The Experts below are selected from a list of 663 Experts worldwide ranked by ideXlab platform
Craig P Fischer - One of the best experts on this subject based on the ideXlab platform.
-
A Randomized Trial of Aprotinin-Free Fibrin Sealant Versus Absorbable Hemostat
2016Co-Authors: Craig P Fischer, Jessica Shen, Bababhai Patel, Jonathan Batiller, Christopher G. Wood, James C. Hart, David M. AlbalaAbstract:Background: This study evaluated the safety and Hemostatic effectiveness of a tranexamic acid- and aprotinin-free fibrin sealant versus an absorbable Hemostat in soft tissue during elective retroperitoneal or intra-abdominal surgery. Materials and Methods: This randomized, active-controlled, multicenter study enrolled patients who were undergoing elective retroperitoneal or intra-abdominal surgery and required adjunctive Hemostatic measures at the target bleeding site (TBS). Patients were rando-mized (time 0 minutes) to receive fibrin sealant or absorbable Hemostat. The primary endpoint was the absence of bleeding at the TBS at 10 minutes. Secondary endpoints included the absence of bleeding at 4 and 7 minutes and the incidence of treatment failure (bleeding at 10 minutes or brisk bleeding requiring additional Hemostatic measures), and the incidence of complications potentially related to bleeding. Adverse events were assessed. Results: Patients (N 124) were randomized to receive fibrin sealant (n 62) or absorbable Hemostat (n 62). A higher percentage of patients who received fibrin sealant versus absorbable Hemostat achieved hemostasis within 10 minutes (95.2 % vs 82.3%; 95 % CI, 1.02-1.35) and also at 4 (74.2 % vs 54.8%; 95 % CI, 1.04-1.80) and 7 (90.3 % vs 77.4%; 95 % CI, 1.00-1.39) minutes. A lower incidence of treatment failure was observed for patients receiving fibrin sealant. Similar incidences of adverse events and complications potentially related to bleeding were observed. Conclusions: This tranexamic acid- and aprotinin-free fibrin sealant is safe and effective for achieving hemostasis in soft tissue during elective retroperitoneal or intra-abdominal surgery
-
erratum to safety and Hemostatic effectiveness of the fibrin pad for severe soft tissue bleeding during abdominal retroperitoneal pelvic and thoracic non cardiac surgery a randomized controlled superiority trial
World Journal of Surgery, 2015Co-Authors: Jeff R Hammond, Jessica Shen, Bababhai Patel, Jonathan Batiller, James Hart, Jonathan B Koea, Peter Baldwin, Axel Arnaud, Craig P FischerAbstract:In surgery, rapid hemostasis can be required in various settings and bleeding intensities to minimize complications related to blood loss. While effective Hemostats are available for mild-to-moderate surgical bleeding, few are effective against challenging severe hemorrhage. We report the effectiveness and safety of the fibrin pad (FP), a novel combination Hemostat (device/human biologic), in controlling severe soft-tissue bleeding as compared to the standard of care (SoC). This randomized, controlled, superiority study enrolled subjects ≥18 years, requiring elective abdominal, retroperitoneal, pelvic, or thoracic (non-cardiac) surgery. A severe target bleeding site (TBS) was identified intra-operatively following which, subjects were randomized to the FP or the SoC group. Hemostatic status was observed at 4 min (primary endpoint) and 10 min post-randomization. Safety variables included TBS-related bleeding and thrombotic events. At 4 min post-randomization, 50/59 (84.7 %) subjects in the FP group and 16/32 (50 %) subjects in the SoC group achieved hemostasis without needing re-treatment (P < 0.0001). Compared to the SoC group, the FP group showed better hemostasis at 10 min post-randomization [58/59 (98.3 %) vs. 28/32 (87.5 %); P = 0.01], lower mean time to hemostasis (6.1 ± 13.5 vs. 17.8 ± 32.0 min), and a less frequent need for re-treatment (5.1 vs. 53.1 %). The triangular test for binary response demonstrated the FP to be superior to SoC (95 % CI 1.474–3.290; P < 0.0001). Safety profiles in both groups were similar to those typically observed after long-duration surgery. The FP is safe and superior to SoC for controlling challenging severe soft-tissue bleeding encountered during intra-abdominal and thoracic surgical procedures.
-
a prospective randomized controlled trial of the efficacy and safety of fibrin pad as an adjunct to control soft tissue bleeding during abdominal retroperitoneal pelvic and thoracic surgery
Journal of The American College of Surgeons, 2013Co-Authors: Craig P Fischer, Grant V Bochicchio, Jessica Shen, Bababhai Patel, Jonathan Batiller, James HartAbstract:Background This study evaluated the Hemostatic effectiveness and safety of Fibrin Pad (Omrix Biopharmaceuticals Ltd.) vs absorbable Hemostat in patients undergoing nonemergent surgery. Fibrin Pad is a topical absorbable Hemostat designed to be effective in a variety of soft tissues and across multiple bleeding intensities. Study Design Patients 18 years and older, requiring abdominal, retroperitoneal, pelvic, or thoracic (noncardiac) surgery and with an appropriate soft-tissue target bleeding site (TBS), were randomized to receive Fibrin Pad or absorbable Hemostat (NCT00658723). Patients were stratified by bleeding severity at the TBS. Assessments included percentage of patients achieving hemostasis at 4 minutes after randomization with no rebleeding requiring treatment during the subsequent 6 minutes (primary endpoint), proportion of patients achieving hemostasis at 10 minutes, and incidence of treatment failure. Results On the primary endpoint, 98.3% of patients with Fibrin Pad and 53.3% with absorbable Hemostat achieved hemostasis at 4 minutes (p Conclusions Fibrin Pad is superior to absorbable Hemostat (SURGICEL Original Absorbable Hemostat [Ethicon]) in soft-tissue bleeding control and is safe and effective as an adjunct for rapidly and reliably achieving hemostasis for soft-tissue bleeding during surgery.
-
a randomized trial of aprotinin free fibrin sealant versus absorbable Hemostat
Clinical and Applied Thrombosis-Hemostasis, 2011Co-Authors: Craig P Fischer, Jessica Shen, Bababhai Patel, Jonathan Batiller, James Hart, Christopher G. Wood, David M. AlbalaAbstract:Background: This study evaluated the safety and Hemostatic effectiveness of a tranexamic acid- and aprotinin-free fibrin sealant versus an absorbable Hemostat in soft tissue during elective retrope...
James Hart - One of the best experts on this subject based on the ideXlab platform.
-
erratum to safety and Hemostatic effectiveness of the fibrin pad for severe soft tissue bleeding during abdominal retroperitoneal pelvic and thoracic non cardiac surgery a randomized controlled superiority trial
World Journal of Surgery, 2015Co-Authors: Jeff R Hammond, Jessica Shen, Bababhai Patel, Jonathan Batiller, James Hart, Jonathan B Koea, Peter Baldwin, Axel Arnaud, Craig P FischerAbstract:In surgery, rapid hemostasis can be required in various settings and bleeding intensities to minimize complications related to blood loss. While effective Hemostats are available for mild-to-moderate surgical bleeding, few are effective against challenging severe hemorrhage. We report the effectiveness and safety of the fibrin pad (FP), a novel combination Hemostat (device/human biologic), in controlling severe soft-tissue bleeding as compared to the standard of care (SoC). This randomized, controlled, superiority study enrolled subjects ≥18 years, requiring elective abdominal, retroperitoneal, pelvic, or thoracic (non-cardiac) surgery. A severe target bleeding site (TBS) was identified intra-operatively following which, subjects were randomized to the FP or the SoC group. Hemostatic status was observed at 4 min (primary endpoint) and 10 min post-randomization. Safety variables included TBS-related bleeding and thrombotic events. At 4 min post-randomization, 50/59 (84.7 %) subjects in the FP group and 16/32 (50 %) subjects in the SoC group achieved hemostasis without needing re-treatment (P < 0.0001). Compared to the SoC group, the FP group showed better hemostasis at 10 min post-randomization [58/59 (98.3 %) vs. 28/32 (87.5 %); P = 0.01], lower mean time to hemostasis (6.1 ± 13.5 vs. 17.8 ± 32.0 min), and a less frequent need for re-treatment (5.1 vs. 53.1 %). The triangular test for binary response demonstrated the FP to be superior to SoC (95 % CI 1.474–3.290; P < 0.0001). Safety profiles in both groups were similar to those typically observed after long-duration surgery. The FP is safe and superior to SoC for controlling challenging severe soft-tissue bleeding encountered during intra-abdominal and thoracic surgical procedures.
-
a prospective randomized controlled trial of the efficacy and safety of fibrin pad as an adjunct to control soft tissue bleeding during abdominal retroperitoneal pelvic and thoracic surgery
Journal of The American College of Surgeons, 2013Co-Authors: Craig P Fischer, Grant V Bochicchio, Jessica Shen, Bababhai Patel, Jonathan Batiller, James HartAbstract:Background This study evaluated the Hemostatic effectiveness and safety of Fibrin Pad (Omrix Biopharmaceuticals Ltd.) vs absorbable Hemostat in patients undergoing nonemergent surgery. Fibrin Pad is a topical absorbable Hemostat designed to be effective in a variety of soft tissues and across multiple bleeding intensities. Study Design Patients 18 years and older, requiring abdominal, retroperitoneal, pelvic, or thoracic (noncardiac) surgery and with an appropriate soft-tissue target bleeding site (TBS), were randomized to receive Fibrin Pad or absorbable Hemostat (NCT00658723). Patients were stratified by bleeding severity at the TBS. Assessments included percentage of patients achieving hemostasis at 4 minutes after randomization with no rebleeding requiring treatment during the subsequent 6 minutes (primary endpoint), proportion of patients achieving hemostasis at 10 minutes, and incidence of treatment failure. Results On the primary endpoint, 98.3% of patients with Fibrin Pad and 53.3% with absorbable Hemostat achieved hemostasis at 4 minutes (p Conclusions Fibrin Pad is superior to absorbable Hemostat (SURGICEL Original Absorbable Hemostat [Ethicon]) in soft-tissue bleeding control and is safe and effective as an adjunct for rapidly and reliably achieving hemostasis for soft-tissue bleeding during surgery.
-
a randomized trial of aprotinin free fibrin sealant versus absorbable Hemostat
Clinical and Applied Thrombosis-Hemostasis, 2011Co-Authors: Craig P Fischer, Jessica Shen, Bababhai Patel, Jonathan Batiller, James Hart, Christopher G. Wood, David M. AlbalaAbstract:Background: This study evaluated the safety and Hemostatic effectiveness of a tranexamic acid- and aprotinin-free fibrin sealant versus an absorbable Hemostat in soft tissue during elective retrope...
Jessica Shen - One of the best experts on this subject based on the ideXlab platform.
-
A Randomized Trial of Aprotinin-Free Fibrin Sealant Versus Absorbable Hemostat
2016Co-Authors: Craig P Fischer, Jessica Shen, Bababhai Patel, Jonathan Batiller, Christopher G. Wood, James C. Hart, David M. AlbalaAbstract:Background: This study evaluated the safety and Hemostatic effectiveness of a tranexamic acid- and aprotinin-free fibrin sealant versus an absorbable Hemostat in soft tissue during elective retroperitoneal or intra-abdominal surgery. Materials and Methods: This randomized, active-controlled, multicenter study enrolled patients who were undergoing elective retroperitoneal or intra-abdominal surgery and required adjunctive Hemostatic measures at the target bleeding site (TBS). Patients were rando-mized (time 0 minutes) to receive fibrin sealant or absorbable Hemostat. The primary endpoint was the absence of bleeding at the TBS at 10 minutes. Secondary endpoints included the absence of bleeding at 4 and 7 minutes and the incidence of treatment failure (bleeding at 10 minutes or brisk bleeding requiring additional Hemostatic measures), and the incidence of complications potentially related to bleeding. Adverse events were assessed. Results: Patients (N 124) were randomized to receive fibrin sealant (n 62) or absorbable Hemostat (n 62). A higher percentage of patients who received fibrin sealant versus absorbable Hemostat achieved hemostasis within 10 minutes (95.2 % vs 82.3%; 95 % CI, 1.02-1.35) and also at 4 (74.2 % vs 54.8%; 95 % CI, 1.04-1.80) and 7 (90.3 % vs 77.4%; 95 % CI, 1.00-1.39) minutes. A lower incidence of treatment failure was observed for patients receiving fibrin sealant. Similar incidences of adverse events and complications potentially related to bleeding were observed. Conclusions: This tranexamic acid- and aprotinin-free fibrin sealant is safe and effective for achieving hemostasis in soft tissue during elective retroperitoneal or intra-abdominal surgery
-
erratum to safety and Hemostatic effectiveness of the fibrin pad for severe soft tissue bleeding during abdominal retroperitoneal pelvic and thoracic non cardiac surgery a randomized controlled superiority trial
World Journal of Surgery, 2015Co-Authors: Jeff R Hammond, Jessica Shen, Bababhai Patel, Jonathan Batiller, James Hart, Jonathan B Koea, Peter Baldwin, Axel Arnaud, Craig P FischerAbstract:In surgery, rapid hemostasis can be required in various settings and bleeding intensities to minimize complications related to blood loss. While effective Hemostats are available for mild-to-moderate surgical bleeding, few are effective against challenging severe hemorrhage. We report the effectiveness and safety of the fibrin pad (FP), a novel combination Hemostat (device/human biologic), in controlling severe soft-tissue bleeding as compared to the standard of care (SoC). This randomized, controlled, superiority study enrolled subjects ≥18 years, requiring elective abdominal, retroperitoneal, pelvic, or thoracic (non-cardiac) surgery. A severe target bleeding site (TBS) was identified intra-operatively following which, subjects were randomized to the FP or the SoC group. Hemostatic status was observed at 4 min (primary endpoint) and 10 min post-randomization. Safety variables included TBS-related bleeding and thrombotic events. At 4 min post-randomization, 50/59 (84.7 %) subjects in the FP group and 16/32 (50 %) subjects in the SoC group achieved hemostasis without needing re-treatment (P < 0.0001). Compared to the SoC group, the FP group showed better hemostasis at 10 min post-randomization [58/59 (98.3 %) vs. 28/32 (87.5 %); P = 0.01], lower mean time to hemostasis (6.1 ± 13.5 vs. 17.8 ± 32.0 min), and a less frequent need for re-treatment (5.1 vs. 53.1 %). The triangular test for binary response demonstrated the FP to be superior to SoC (95 % CI 1.474–3.290; P < 0.0001). Safety profiles in both groups were similar to those typically observed after long-duration surgery. The FP is safe and superior to SoC for controlling challenging severe soft-tissue bleeding encountered during intra-abdominal and thoracic surgical procedures.
-
a prospective randomized controlled trial of the efficacy and safety of fibrin pad as an adjunct to control soft tissue bleeding during abdominal retroperitoneal pelvic and thoracic surgery
Journal of The American College of Surgeons, 2013Co-Authors: Craig P Fischer, Grant V Bochicchio, Jessica Shen, Bababhai Patel, Jonathan Batiller, James HartAbstract:Background This study evaluated the Hemostatic effectiveness and safety of Fibrin Pad (Omrix Biopharmaceuticals Ltd.) vs absorbable Hemostat in patients undergoing nonemergent surgery. Fibrin Pad is a topical absorbable Hemostat designed to be effective in a variety of soft tissues and across multiple bleeding intensities. Study Design Patients 18 years and older, requiring abdominal, retroperitoneal, pelvic, or thoracic (noncardiac) surgery and with an appropriate soft-tissue target bleeding site (TBS), were randomized to receive Fibrin Pad or absorbable Hemostat (NCT00658723). Patients were stratified by bleeding severity at the TBS. Assessments included percentage of patients achieving hemostasis at 4 minutes after randomization with no rebleeding requiring treatment during the subsequent 6 minutes (primary endpoint), proportion of patients achieving hemostasis at 10 minutes, and incidence of treatment failure. Results On the primary endpoint, 98.3% of patients with Fibrin Pad and 53.3% with absorbable Hemostat achieved hemostasis at 4 minutes (p Conclusions Fibrin Pad is superior to absorbable Hemostat (SURGICEL Original Absorbable Hemostat [Ethicon]) in soft-tissue bleeding control and is safe and effective as an adjunct for rapidly and reliably achieving hemostasis for soft-tissue bleeding during surgery.
-
a randomized trial of aprotinin free fibrin sealant versus absorbable Hemostat
Clinical and Applied Thrombosis-Hemostasis, 2011Co-Authors: Craig P Fischer, Jessica Shen, Bababhai Patel, Jonathan Batiller, James Hart, Christopher G. Wood, David M. AlbalaAbstract:Background: This study evaluated the safety and Hemostatic effectiveness of a tranexamic acid- and aprotinin-free fibrin sealant versus an absorbable Hemostat in soft tissue during elective retrope...
Jonathan Batiller - One of the best experts on this subject based on the ideXlab platform.
-
A Randomized Trial of Aprotinin-Free Fibrin Sealant Versus Absorbable Hemostat
2016Co-Authors: Craig P Fischer, Jessica Shen, Bababhai Patel, Jonathan Batiller, Christopher G. Wood, James C. Hart, David M. AlbalaAbstract:Background: This study evaluated the safety and Hemostatic effectiveness of a tranexamic acid- and aprotinin-free fibrin sealant versus an absorbable Hemostat in soft tissue during elective retroperitoneal or intra-abdominal surgery. Materials and Methods: This randomized, active-controlled, multicenter study enrolled patients who were undergoing elective retroperitoneal or intra-abdominal surgery and required adjunctive Hemostatic measures at the target bleeding site (TBS). Patients were rando-mized (time 0 minutes) to receive fibrin sealant or absorbable Hemostat. The primary endpoint was the absence of bleeding at the TBS at 10 minutes. Secondary endpoints included the absence of bleeding at 4 and 7 minutes and the incidence of treatment failure (bleeding at 10 minutes or brisk bleeding requiring additional Hemostatic measures), and the incidence of complications potentially related to bleeding. Adverse events were assessed. Results: Patients (N 124) were randomized to receive fibrin sealant (n 62) or absorbable Hemostat (n 62). A higher percentage of patients who received fibrin sealant versus absorbable Hemostat achieved hemostasis within 10 minutes (95.2 % vs 82.3%; 95 % CI, 1.02-1.35) and also at 4 (74.2 % vs 54.8%; 95 % CI, 1.04-1.80) and 7 (90.3 % vs 77.4%; 95 % CI, 1.00-1.39) minutes. A lower incidence of treatment failure was observed for patients receiving fibrin sealant. Similar incidences of adverse events and complications potentially related to bleeding were observed. Conclusions: This tranexamic acid- and aprotinin-free fibrin sealant is safe and effective for achieving hemostasis in soft tissue during elective retroperitoneal or intra-abdominal surgery
-
erratum to safety and Hemostatic effectiveness of the fibrin pad for severe soft tissue bleeding during abdominal retroperitoneal pelvic and thoracic non cardiac surgery a randomized controlled superiority trial
World Journal of Surgery, 2015Co-Authors: Jeff R Hammond, Jessica Shen, Bababhai Patel, Jonathan Batiller, James Hart, Jonathan B Koea, Peter Baldwin, Axel Arnaud, Craig P FischerAbstract:In surgery, rapid hemostasis can be required in various settings and bleeding intensities to minimize complications related to blood loss. While effective Hemostats are available for mild-to-moderate surgical bleeding, few are effective against challenging severe hemorrhage. We report the effectiveness and safety of the fibrin pad (FP), a novel combination Hemostat (device/human biologic), in controlling severe soft-tissue bleeding as compared to the standard of care (SoC). This randomized, controlled, superiority study enrolled subjects ≥18 years, requiring elective abdominal, retroperitoneal, pelvic, or thoracic (non-cardiac) surgery. A severe target bleeding site (TBS) was identified intra-operatively following which, subjects were randomized to the FP or the SoC group. Hemostatic status was observed at 4 min (primary endpoint) and 10 min post-randomization. Safety variables included TBS-related bleeding and thrombotic events. At 4 min post-randomization, 50/59 (84.7 %) subjects in the FP group and 16/32 (50 %) subjects in the SoC group achieved hemostasis without needing re-treatment (P < 0.0001). Compared to the SoC group, the FP group showed better hemostasis at 10 min post-randomization [58/59 (98.3 %) vs. 28/32 (87.5 %); P = 0.01], lower mean time to hemostasis (6.1 ± 13.5 vs. 17.8 ± 32.0 min), and a less frequent need for re-treatment (5.1 vs. 53.1 %). The triangular test for binary response demonstrated the FP to be superior to SoC (95 % CI 1.474–3.290; P < 0.0001). Safety profiles in both groups were similar to those typically observed after long-duration surgery. The FP is safe and superior to SoC for controlling challenging severe soft-tissue bleeding encountered during intra-abdominal and thoracic surgical procedures.
-
a prospective randomized controlled trial of the efficacy and safety of fibrin pad as an adjunct to control soft tissue bleeding during abdominal retroperitoneal pelvic and thoracic surgery
Journal of The American College of Surgeons, 2013Co-Authors: Craig P Fischer, Grant V Bochicchio, Jessica Shen, Bababhai Patel, Jonathan Batiller, James HartAbstract:Background This study evaluated the Hemostatic effectiveness and safety of Fibrin Pad (Omrix Biopharmaceuticals Ltd.) vs absorbable Hemostat in patients undergoing nonemergent surgery. Fibrin Pad is a topical absorbable Hemostat designed to be effective in a variety of soft tissues and across multiple bleeding intensities. Study Design Patients 18 years and older, requiring abdominal, retroperitoneal, pelvic, or thoracic (noncardiac) surgery and with an appropriate soft-tissue target bleeding site (TBS), were randomized to receive Fibrin Pad or absorbable Hemostat (NCT00658723). Patients were stratified by bleeding severity at the TBS. Assessments included percentage of patients achieving hemostasis at 4 minutes after randomization with no rebleeding requiring treatment during the subsequent 6 minutes (primary endpoint), proportion of patients achieving hemostasis at 10 minutes, and incidence of treatment failure. Results On the primary endpoint, 98.3% of patients with Fibrin Pad and 53.3% with absorbable Hemostat achieved hemostasis at 4 minutes (p Conclusions Fibrin Pad is superior to absorbable Hemostat (SURGICEL Original Absorbable Hemostat [Ethicon]) in soft-tissue bleeding control and is safe and effective as an adjunct for rapidly and reliably achieving hemostasis for soft-tissue bleeding during surgery.
-
a randomized trial of aprotinin free fibrin sealant versus absorbable Hemostat
Clinical and Applied Thrombosis-Hemostasis, 2011Co-Authors: Craig P Fischer, Jessica Shen, Bababhai Patel, Jonathan Batiller, James Hart, Christopher G. Wood, David M. AlbalaAbstract:Background: This study evaluated the safety and Hemostatic effectiveness of a tranexamic acid- and aprotinin-free fibrin sealant versus an absorbable Hemostat in soft tissue during elective retrope...
Bababhai Patel - One of the best experts on this subject based on the ideXlab platform.
-
A Randomized Trial of Aprotinin-Free Fibrin Sealant Versus Absorbable Hemostat
2016Co-Authors: Craig P Fischer, Jessica Shen, Bababhai Patel, Jonathan Batiller, Christopher G. Wood, James C. Hart, David M. AlbalaAbstract:Background: This study evaluated the safety and Hemostatic effectiveness of a tranexamic acid- and aprotinin-free fibrin sealant versus an absorbable Hemostat in soft tissue during elective retroperitoneal or intra-abdominal surgery. Materials and Methods: This randomized, active-controlled, multicenter study enrolled patients who were undergoing elective retroperitoneal or intra-abdominal surgery and required adjunctive Hemostatic measures at the target bleeding site (TBS). Patients were rando-mized (time 0 minutes) to receive fibrin sealant or absorbable Hemostat. The primary endpoint was the absence of bleeding at the TBS at 10 minutes. Secondary endpoints included the absence of bleeding at 4 and 7 minutes and the incidence of treatment failure (bleeding at 10 minutes or brisk bleeding requiring additional Hemostatic measures), and the incidence of complications potentially related to bleeding. Adverse events were assessed. Results: Patients (N 124) were randomized to receive fibrin sealant (n 62) or absorbable Hemostat (n 62). A higher percentage of patients who received fibrin sealant versus absorbable Hemostat achieved hemostasis within 10 minutes (95.2 % vs 82.3%; 95 % CI, 1.02-1.35) and also at 4 (74.2 % vs 54.8%; 95 % CI, 1.04-1.80) and 7 (90.3 % vs 77.4%; 95 % CI, 1.00-1.39) minutes. A lower incidence of treatment failure was observed for patients receiving fibrin sealant. Similar incidences of adverse events and complications potentially related to bleeding were observed. Conclusions: This tranexamic acid- and aprotinin-free fibrin sealant is safe and effective for achieving hemostasis in soft tissue during elective retroperitoneal or intra-abdominal surgery
-
erratum to safety and Hemostatic effectiveness of the fibrin pad for severe soft tissue bleeding during abdominal retroperitoneal pelvic and thoracic non cardiac surgery a randomized controlled superiority trial
World Journal of Surgery, 2015Co-Authors: Jeff R Hammond, Jessica Shen, Bababhai Patel, Jonathan Batiller, James Hart, Jonathan B Koea, Peter Baldwin, Axel Arnaud, Craig P FischerAbstract:In surgery, rapid hemostasis can be required in various settings and bleeding intensities to minimize complications related to blood loss. While effective Hemostats are available for mild-to-moderate surgical bleeding, few are effective against challenging severe hemorrhage. We report the effectiveness and safety of the fibrin pad (FP), a novel combination Hemostat (device/human biologic), in controlling severe soft-tissue bleeding as compared to the standard of care (SoC). This randomized, controlled, superiority study enrolled subjects ≥18 years, requiring elective abdominal, retroperitoneal, pelvic, or thoracic (non-cardiac) surgery. A severe target bleeding site (TBS) was identified intra-operatively following which, subjects were randomized to the FP or the SoC group. Hemostatic status was observed at 4 min (primary endpoint) and 10 min post-randomization. Safety variables included TBS-related bleeding and thrombotic events. At 4 min post-randomization, 50/59 (84.7 %) subjects in the FP group and 16/32 (50 %) subjects in the SoC group achieved hemostasis without needing re-treatment (P < 0.0001). Compared to the SoC group, the FP group showed better hemostasis at 10 min post-randomization [58/59 (98.3 %) vs. 28/32 (87.5 %); P = 0.01], lower mean time to hemostasis (6.1 ± 13.5 vs. 17.8 ± 32.0 min), and a less frequent need for re-treatment (5.1 vs. 53.1 %). The triangular test for binary response demonstrated the FP to be superior to SoC (95 % CI 1.474–3.290; P < 0.0001). Safety profiles in both groups were similar to those typically observed after long-duration surgery. The FP is safe and superior to SoC for controlling challenging severe soft-tissue bleeding encountered during intra-abdominal and thoracic surgical procedures.
-
a prospective randomized controlled trial of the efficacy and safety of fibrin pad as an adjunct to control soft tissue bleeding during abdominal retroperitoneal pelvic and thoracic surgery
Journal of The American College of Surgeons, 2013Co-Authors: Craig P Fischer, Grant V Bochicchio, Jessica Shen, Bababhai Patel, Jonathan Batiller, James HartAbstract:Background This study evaluated the Hemostatic effectiveness and safety of Fibrin Pad (Omrix Biopharmaceuticals Ltd.) vs absorbable Hemostat in patients undergoing nonemergent surgery. Fibrin Pad is a topical absorbable Hemostat designed to be effective in a variety of soft tissues and across multiple bleeding intensities. Study Design Patients 18 years and older, requiring abdominal, retroperitoneal, pelvic, or thoracic (noncardiac) surgery and with an appropriate soft-tissue target bleeding site (TBS), were randomized to receive Fibrin Pad or absorbable Hemostat (NCT00658723). Patients were stratified by bleeding severity at the TBS. Assessments included percentage of patients achieving hemostasis at 4 minutes after randomization with no rebleeding requiring treatment during the subsequent 6 minutes (primary endpoint), proportion of patients achieving hemostasis at 10 minutes, and incidence of treatment failure. Results On the primary endpoint, 98.3% of patients with Fibrin Pad and 53.3% with absorbable Hemostat achieved hemostasis at 4 minutes (p Conclusions Fibrin Pad is superior to absorbable Hemostat (SURGICEL Original Absorbable Hemostat [Ethicon]) in soft-tissue bleeding control and is safe and effective as an adjunct for rapidly and reliably achieving hemostasis for soft-tissue bleeding during surgery.
-
a randomized trial of aprotinin free fibrin sealant versus absorbable Hemostat
Clinical and Applied Thrombosis-Hemostasis, 2011Co-Authors: Craig P Fischer, Jessica Shen, Bababhai Patel, Jonathan Batiller, James Hart, Christopher G. Wood, David M. AlbalaAbstract:Background: This study evaluated the safety and Hemostatic effectiveness of a tranexamic acid- and aprotinin-free fibrin sealant versus an absorbable Hemostat in soft tissue during elective retrope...