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Ian Roberts - One of the best experts on this subject based on the ideXlab platform.
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effect of tranexamic acid by baseline risk of death in acute bleeding patients a meta analysis of individual patient level data from 28 333 patients
BJA: British Journal of Anaesthesia, 2020Co-Authors: Ian Roberts, Katharine Ker, Francoisxavier Ageron, Angele Gayetageron, Timothy J Coats, Haleema Shakurstill, Aasia Kayani, Amber Geer, Bernard NdunguAbstract:Abstract Background Early administration of the Antifibrinolytic drug tranexamic acid reduces death from bleeding in trauma and postpartum haemorrhage. We examined how the effectiveness and safety of Antifibrinolytic drugs varies by the baseline risk of death as a result of bleeding. Methods We performed an individual patient-level data meta-analysis of randomised trials including more than 1000 patients that assessed Antifibrinolytics in acute severe bleeding. We identified trials performed between January 1, 1946 and July 5, 2018 (PROSPERO, number 42016052155). Results Two randomised trials were selected where 28 333 patients received tranexamic acid treatment within 3 h after the onset of acute bleeding. Baseline characteristics to estimate the risk of death as a result of bleeding were divided into four categories: Low (0–5%), intermediate (6–10%), high (11–20%), and very high (>20%). Most patients had a low baseline risk of death as a result of bleeding (23 008 [81%]). Deaths as a result of bleeding occurred in all baseline risk categories with 240 (1%), 202 (8%), 232 (14%), and 357 (30%) deaths in the low-, intermediate-, high-, and very high-risk categories, respectively. The effectiveness of tranexamic acid did not vary by baseline risk when given within 3 h after bleeding onset (P=0.51 for interaction term). There was no increased risk of vascular occlusive events with tranexamic acid and it did not vary by baseline risk categories (P=0.25). Conclusions Tranexamic acid appears to be safe and effective regardless of baseline risk of death. Because many deaths are in patients at low and intermediate risk, tranexamic acid use should not be restricted to the most severely injured or bleeding patients.
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The effect of tranexamic acid by baseline risk in acute bleeding patients: a meta-analysis of individual patient-level data from 28 333 patients.
2020Co-Authors: Francoisxavier Ageron, Ian Roberts, Katharine Ker, Timothy J Coats, Angele Gayet-ageron, Haleema Shakur-still, Antifibrinolytics Trials CollaborationAbstract:BACKGROUND:Early administration of the Antifibrinolytic drug tranexamic acid reduces death from bleeding in trauma and postpartum haemorrhage. We examined how the effectiveness and safety of Antifibrinolytic drugs varies by the baseline risk of death as a result of bleeding. METHODS:We performed an individual patient-level data meta-analysis of randomised trials including more than 1000 patients that assessed Antifibrinolytics in acute severe bleeding. We identified trials performed between January 1, 1946 and July 5, 2018 (PROSPERO, number 42016052155). RESULTS:Two randomised trials were selected where 28 333 patients received tranexamic acid treatment within 3 h after the onset of acute bleeding. Baseline characteristics to estimate the risk of death as a result of bleeding were divided into four categories: Low (0-5%), intermediate (6-10%), high (11-20%), and very high (>20%). Most patients had a low baseline risk of death as a result of bleeding (23 008 [81%]). Deaths as a result of bleeding occurred in all baseline risk categories with 240 (1%), 202 (8%), 232 (14%), and 357 (30%) deaths in the low-, intermediate-, high-, and very high-risk categories, respectively. The effectiveness of tranexamic acid did not vary by baseline risk when given within 3 h after bleeding onset (P=0.51 for interaction term). There was no increased risk of vascular occlusive events with tranexamic acid and it did not vary by baseline risk categories (P=0.25). CONCLUSIONS:Tranexamic acid appears to be safe and effective regardless of baseline risk. Because many deaths are in patients at low and intermediate risk, tranexamic acid use should not be restricted to the most severely injured or bleeding patients
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The effectiveness and safety of Antifibrinolytics in patients with acute intracranial haemorrhage: statistical analysis plan for an individual patient data meta-analysis [version 2; referees: 2 approved]
Wellcome, 2018Co-Authors: Katharine Ker, Abda Mahmood, Katie Flaherty, Nikola Sprigg, David Prieto-merino, Philip Bath, Zhe Kang Law, Ian RobertsAbstract:Introduction: The Antifibrinolytic Trialists Collaboration aims to increase knowledge about the effectiveness and safety of Antifibrinolytic treatment by conducting individual patient data (IPD) meta-analyses of randomised trials. This article presents the statistical analysis plan for an IPD meta-analysis of the effects of Antifibrinolytics for acute intracranial haemorrhage. Methods: The protocol for the IPD meta-analysis has been registered with PROSPERO (CRD42016052155). We will conduct an individual patient data meta-analysis of randomised controlled trials with 1000 patients or more assessing the effects of Antifibrinolytics in acute intracranial haemorrhage. We will assess the effect on two co-primary outcomes: 1) Death in hospital within 30 days of randomisation, and 2) Death or dependency at final follow-up within 90 days of randomisation. The co-primary outcomes will be limited to patients treated within three hours of injury or stroke onset. We will report treatment effects using odds ratios and 95% confidence intervals. We use logistic regression models to examine how the effect of Antifibrinolytics vary by time to treatment, severity of intracranial bleeding, and age. We will also examine the effect of Antifibrinolytics on secondary outcomes including death, dependency, vascular occlusive events, seizures, and neurological outcomes. Secondary outcomes will be assessed in all patients irrespective of time of treatment. All analyses will be conducted on an intention-to-treat basis. Conclusions: This IPD meta-analysis will examine important clinical questions about the effects of Antifibrinolytic treatment in patients with intracranial haemorrhage that cannot be answered using aggregate data. With IPD we can examine how effects vary by time to treatment, bleeding severity, and age, to gain better understanding of the balance of benefit and harms on which to base recommendations for practice
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the effectiveness and safety of Antifibrinolytics in patients with acute intracranial haemorrhage statistical analysis plan for an individual patient data meta analysis
Wellcome open research, 2017Co-Authors: Abda Mahmood, Katie Flaherty, Philip M.w. Bath, Nikola Sprigg, David Prietomerino, Ian RobertsAbstract:Introduction: The Antifibrinolytic Trialists Collaboration aims to increase knowledge about the effectiveness and safety of Antifibrinolytic treatment by conducting individual patient data (IPD) meta-analyses of randomised trials. This article presents the statistical analysis plan for an IPD meta-analysis of the effects of Antifibrinolytics for acute intracranial haemorrhage. Methods: The protocol for the IPD meta-analysis has been registered with PROSPERO (CRD42016052155). We will conduct an individual patient data meta-analysis of randomised controlled trials with 1000 patients or more assessing the effects of Antifibrinolytics in acute intracranial haemorrhage. We will assess the effect on two co-primary outcomes: 1) death in hospital at end of trial follow-up, and 2) death in hospital or dependency at end of trial follow-up. The co-primary outcomes will be limited to patients treated within three hours of injury or stroke onset. We will report treatment effects using odds ratios and 95% confidence intervals. We use logistic regression models to examine how the effect of Antifibrinolytics vary by time to treatment, severity of intracranial bleeding, and age. We will also examine the effect of Antifibrinolytics on secondary outcomes including death, dependency, vascular occlusive events, seizures, and neurological outcomes. Secondary outcomes will be assessed in all patients irrespective of time of treatment. All analyses will be conducted on an intention-to-treat basis. Conclusions: This IPD meta-analysis will examine important clinical questions about the effects of Antifibrinolytic treatment in patients with intracranial haemorrhage that cannot be answered using aggregate data. With IPD we can examine how effects vary by time to treatment, bleeding severity, and age, to gain better understanding of the balance of benefit and harms on which to base recommendations for practice.
Katharine Ker - One of the best experts on this subject based on the ideXlab platform.
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effect of tranexamic acid by baseline risk of death in acute bleeding patients a meta analysis of individual patient level data from 28 333 patients
BJA: British Journal of Anaesthesia, 2020Co-Authors: Ian Roberts, Katharine Ker, Francoisxavier Ageron, Angele Gayetageron, Timothy J Coats, Haleema Shakurstill, Aasia Kayani, Amber Geer, Bernard NdunguAbstract:Abstract Background Early administration of the Antifibrinolytic drug tranexamic acid reduces death from bleeding in trauma and postpartum haemorrhage. We examined how the effectiveness and safety of Antifibrinolytic drugs varies by the baseline risk of death as a result of bleeding. Methods We performed an individual patient-level data meta-analysis of randomised trials including more than 1000 patients that assessed Antifibrinolytics in acute severe bleeding. We identified trials performed between January 1, 1946 and July 5, 2018 (PROSPERO, number 42016052155). Results Two randomised trials were selected where 28 333 patients received tranexamic acid treatment within 3 h after the onset of acute bleeding. Baseline characteristics to estimate the risk of death as a result of bleeding were divided into four categories: Low (0–5%), intermediate (6–10%), high (11–20%), and very high (>20%). Most patients had a low baseline risk of death as a result of bleeding (23 008 [81%]). Deaths as a result of bleeding occurred in all baseline risk categories with 240 (1%), 202 (8%), 232 (14%), and 357 (30%) deaths in the low-, intermediate-, high-, and very high-risk categories, respectively. The effectiveness of tranexamic acid did not vary by baseline risk when given within 3 h after bleeding onset (P=0.51 for interaction term). There was no increased risk of vascular occlusive events with tranexamic acid and it did not vary by baseline risk categories (P=0.25). Conclusions Tranexamic acid appears to be safe and effective regardless of baseline risk of death. Because many deaths are in patients at low and intermediate risk, tranexamic acid use should not be restricted to the most severely injured or bleeding patients.
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The effect of tranexamic acid by baseline risk in acute bleeding patients: a meta-analysis of individual patient-level data from 28 333 patients.
2020Co-Authors: Francoisxavier Ageron, Ian Roberts, Katharine Ker, Timothy J Coats, Angele Gayet-ageron, Haleema Shakur-still, Antifibrinolytics Trials CollaborationAbstract:BACKGROUND:Early administration of the Antifibrinolytic drug tranexamic acid reduces death from bleeding in trauma and postpartum haemorrhage. We examined how the effectiveness and safety of Antifibrinolytic drugs varies by the baseline risk of death as a result of bleeding. METHODS:We performed an individual patient-level data meta-analysis of randomised trials including more than 1000 patients that assessed Antifibrinolytics in acute severe bleeding. We identified trials performed between January 1, 1946 and July 5, 2018 (PROSPERO, number 42016052155). RESULTS:Two randomised trials were selected where 28 333 patients received tranexamic acid treatment within 3 h after the onset of acute bleeding. Baseline characteristics to estimate the risk of death as a result of bleeding were divided into four categories: Low (0-5%), intermediate (6-10%), high (11-20%), and very high (>20%). Most patients had a low baseline risk of death as a result of bleeding (23 008 [81%]). Deaths as a result of bleeding occurred in all baseline risk categories with 240 (1%), 202 (8%), 232 (14%), and 357 (30%) deaths in the low-, intermediate-, high-, and very high-risk categories, respectively. The effectiveness of tranexamic acid did not vary by baseline risk when given within 3 h after bleeding onset (P=0.51 for interaction term). There was no increased risk of vascular occlusive events with tranexamic acid and it did not vary by baseline risk categories (P=0.25). CONCLUSIONS:Tranexamic acid appears to be safe and effective regardless of baseline risk. Because many deaths are in patients at low and intermediate risk, tranexamic acid use should not be restricted to the most severely injured or bleeding patients
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The effectiveness and safety of Antifibrinolytics in patients with acute intracranial haemorrhage: statistical analysis plan for an individual patient data meta-analysis [version 2; referees: 2 approved]
Wellcome, 2018Co-Authors: Katharine Ker, Abda Mahmood, Katie Flaherty, Nikola Sprigg, David Prieto-merino, Philip Bath, Zhe Kang Law, Ian RobertsAbstract:Introduction: The Antifibrinolytic Trialists Collaboration aims to increase knowledge about the effectiveness and safety of Antifibrinolytic treatment by conducting individual patient data (IPD) meta-analyses of randomised trials. This article presents the statistical analysis plan for an IPD meta-analysis of the effects of Antifibrinolytics for acute intracranial haemorrhage. Methods: The protocol for the IPD meta-analysis has been registered with PROSPERO (CRD42016052155). We will conduct an individual patient data meta-analysis of randomised controlled trials with 1000 patients or more assessing the effects of Antifibrinolytics in acute intracranial haemorrhage. We will assess the effect on two co-primary outcomes: 1) Death in hospital within 30 days of randomisation, and 2) Death or dependency at final follow-up within 90 days of randomisation. The co-primary outcomes will be limited to patients treated within three hours of injury or stroke onset. We will report treatment effects using odds ratios and 95% confidence intervals. We use logistic regression models to examine how the effect of Antifibrinolytics vary by time to treatment, severity of intracranial bleeding, and age. We will also examine the effect of Antifibrinolytics on secondary outcomes including death, dependency, vascular occlusive events, seizures, and neurological outcomes. Secondary outcomes will be assessed in all patients irrespective of time of treatment. All analyses will be conducted on an intention-to-treat basis. Conclusions: This IPD meta-analysis will examine important clinical questions about the effects of Antifibrinolytic treatment in patients with intracranial haemorrhage that cannot be answered using aggregate data. With IPD we can examine how effects vary by time to treatment, bleeding severity, and age, to gain better understanding of the balance of benefit and harms on which to base recommendations for practice
Francoisxavier Ageron - One of the best experts on this subject based on the ideXlab platform.
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effect of tranexamic acid by baseline risk of death in acute bleeding patients a meta analysis of individual patient level data from 28 333 patients
BJA: British Journal of Anaesthesia, 2020Co-Authors: Ian Roberts, Katharine Ker, Francoisxavier Ageron, Angele Gayetageron, Timothy J Coats, Haleema Shakurstill, Aasia Kayani, Amber Geer, Bernard NdunguAbstract:Abstract Background Early administration of the Antifibrinolytic drug tranexamic acid reduces death from bleeding in trauma and postpartum haemorrhage. We examined how the effectiveness and safety of Antifibrinolytic drugs varies by the baseline risk of death as a result of bleeding. Methods We performed an individual patient-level data meta-analysis of randomised trials including more than 1000 patients that assessed Antifibrinolytics in acute severe bleeding. We identified trials performed between January 1, 1946 and July 5, 2018 (PROSPERO, number 42016052155). Results Two randomised trials were selected where 28 333 patients received tranexamic acid treatment within 3 h after the onset of acute bleeding. Baseline characteristics to estimate the risk of death as a result of bleeding were divided into four categories: Low (0–5%), intermediate (6–10%), high (11–20%), and very high (>20%). Most patients had a low baseline risk of death as a result of bleeding (23 008 [81%]). Deaths as a result of bleeding occurred in all baseline risk categories with 240 (1%), 202 (8%), 232 (14%), and 357 (30%) deaths in the low-, intermediate-, high-, and very high-risk categories, respectively. The effectiveness of tranexamic acid did not vary by baseline risk when given within 3 h after bleeding onset (P=0.51 for interaction term). There was no increased risk of vascular occlusive events with tranexamic acid and it did not vary by baseline risk categories (P=0.25). Conclusions Tranexamic acid appears to be safe and effective regardless of baseline risk of death. Because many deaths are in patients at low and intermediate risk, tranexamic acid use should not be restricted to the most severely injured or bleeding patients.
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The effect of tranexamic acid by baseline risk in acute bleeding patients: a meta-analysis of individual patient-level data from 28 333 patients.
2020Co-Authors: Francoisxavier Ageron, Ian Roberts, Katharine Ker, Timothy J Coats, Angele Gayet-ageron, Haleema Shakur-still, Antifibrinolytics Trials CollaborationAbstract:BACKGROUND:Early administration of the Antifibrinolytic drug tranexamic acid reduces death from bleeding in trauma and postpartum haemorrhage. We examined how the effectiveness and safety of Antifibrinolytic drugs varies by the baseline risk of death as a result of bleeding. METHODS:We performed an individual patient-level data meta-analysis of randomised trials including more than 1000 patients that assessed Antifibrinolytics in acute severe bleeding. We identified trials performed between January 1, 1946 and July 5, 2018 (PROSPERO, number 42016052155). RESULTS:Two randomised trials were selected where 28 333 patients received tranexamic acid treatment within 3 h after the onset of acute bleeding. Baseline characteristics to estimate the risk of death as a result of bleeding were divided into four categories: Low (0-5%), intermediate (6-10%), high (11-20%), and very high (>20%). Most patients had a low baseline risk of death as a result of bleeding (23 008 [81%]). Deaths as a result of bleeding occurred in all baseline risk categories with 240 (1%), 202 (8%), 232 (14%), and 357 (30%) deaths in the low-, intermediate-, high-, and very high-risk categories, respectively. The effectiveness of tranexamic acid did not vary by baseline risk when given within 3 h after bleeding onset (P=0.51 for interaction term). There was no increased risk of vascular occlusive events with tranexamic acid and it did not vary by baseline risk categories (P=0.25). CONCLUSIONS:Tranexamic acid appears to be safe and effective regardless of baseline risk. Because many deaths are in patients at low and intermediate risk, tranexamic acid use should not be restricted to the most severely injured or bleeding patients
Ryuichi Tanaka - One of the best experts on this subject based on the ideXlab platform.
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predictors of hematoma enlargement in patients with intracerebral hemorrhage treated with rapid administration of Antifibrinolytic agents and strict blood pressure control
Journal of Neurosurgery, 2007Co-Authors: Takatoshi Sorimachi, Yukihiko Fujii, Kenichi Morita, Ryuichi TanakaAbstract:Object Hematoma enlargement is a major cause of poor outcome in patients with intracerebral hemorrhage (ICH). A combination of rapid administration of Antifibrinolytics and strict blood pressure (BP) control for prevention of hematoma enlargement has been recently reported. The authors examined the incidence and predictors of hematoma enlargement in patients with ICH who were treated with this therapy. Methods Rapid administration of Antifibrinolytic agents consisted of intravenous administration of 2 g tranexamic acid over 10 minutes. Systolic BP was strictly maintained below 150 mm Hg using intravenous nicardipine. Immediately after diagnosis of ICH on computed tomography (CT), 188 patients who were admitted within 24 hours of symptom onset were treated with a combination of rapid administration of Antifibrinolytic agents and BP control. Hematoma enlargement was determined on the basis of a second CT scan performed the day after admission. Several factors, including those that have been reported to affe...
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rapid administration of Antifibrinolytics and strict blood pressure control for intracerebral hemorrhage
Neurosurgery, 2005Co-Authors: Takatoshi Sorimachi, Yukihiko Fujii, Kenichi Morita, Ryuichi TanakaAbstract:OBJECTIVE: Hematoma growth is a major cause of poor outcome in patients with intracerebral hemorrhage. We evaluated the efficacy of a combination of rapid Antifibrinolytic therapy and strict blood pressure control for prevention of hematoma growth in this retrospective study. METHODS: Systolic blood pressure was strictly controlled below 150 mm Hg by use of intravenously administered nicardipine (BPC). Prolonged infusion of Antifibrinolytic therapy was given by intravenous administration of 1 g tranexamic acid over a period of 6 hours (PAF). Rapid administration of Antifibrinolytic therapy was given by intravenous administration of 2 g tranexamic acid over a period of 10 minutes (RAF). Immediately after diagnosis of intracerebral hemorrhage on computed tomographic scan, 156 patients who were admitted within 24 hours of onset were treated with either a combination of PAF and BPC (PAF group) or a combination of RAF and BPC (RAF group). The incidence of hematoma growth determined by a second computed tomographic scan the day after admission was compared between the PAF and the RAF groups. RESULTS: Hematoma growth was observed in 11 (17.5%) of 63 patients in the PAF group and 4 (4.3%) of 93 patients in the RAF group using a 20% cutoff value for hematoma enlargement. The RAF group showed a significantly low incidence of hematoma growth compared with the PAF group (P < 0.05). Between the two groups, there was no significant difference in any of the other factors reported to affect hematoma growth. CONCLUSION: The combination of rapid administration of Antifibrinolytics and strict blood pressure control may prevent hematoma growth in patients with intracerebral hemorrhage.
Kevin Phan - One of the best experts on this subject based on the ideXlab platform.
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the perioperative efficacy and safety of Antifibrinolytics in adult spinal fusion surgery a systematic review and meta analysis
Spine, 2018Co-Authors: Victor M. Lu, Yamting Ho, Mithun Nambiar, Ralph J Mobbs, Kevin PhanAbstract:STUDY DESIGN: Systematic review and meta-analysis. OBJECTIVE: Compare outcomes of adult patients undergoing spinal fusion surgery who receive and do not receive perioperative Antifibrinolytics to reduce operative blood loss. SUMMARY OF BACKGROUND DATA: The clinical potential for Antifibrinolytics such as tranexamic acid and epsilon aminocaproic acid to significantly reduce blood loss during adult spinal fusion surgery remains underexplored. Outcomes for assessment included operative blood loss, and other surgical, clinical, and haematological outcomes. METHODS: We followed the recommended Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines for systematic reviews. Electronic database searches identified 2041 for screening. Data were extracted and analyzed using meta-analysis of proportions. RESULTS: A total of 11 randomized controlled trials with a total of 937 adult spinal fusion surgery patients were included for analysis. There were 472 (50%) patients who were treated with Antifibrinolytics, with 345 of 472 (73%) and 127 of 472 (27%) receiving tranexamic acid and epsilon aminocaproic acid respectively. The use of Antifibrinolytics was associated with significantly lower intraoperative (MD -127.08 mL; P = 0.002) and total blood loss (MD -229.76 mL; P < 0.00001), as well as incidence of blood transfusion (OR 0.58; P = 0.04). There was no significant difference with Antifibrinolytic use in terms of many surgical parameters, including surgery duration (P = 0.50), overall complications (P = 0.21), and length of stay (P = 0.88). Finally, postoperative haemoglobin was significantly greater (MD 0.30 g/dL; P = 0.02) following Antifibrinolytic use, with other haematological parameters mostly unaffected. CONCLUSION: Based on the highest level comparative evidence available, the possibility for blood loss reduction in adult spinal fusion surgery with the use of perioperative Antifibrinolytics is not unreasonable, as it appears both efficacious and safe. In addition to further, larger investigations to validate the associations found in this study, practical aspects such as cost-benefit analysis, and long-term follow-up will further enhance our understanding. LEVEL OF EVIDENCE: 1.