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Karlgosta Ljungstrom - One of the best experts on this subject based on the ideXlab platform.

Robert P Wise - One of the best experts on this subject based on the ideXlab platform.

  • anaphylactoid reactions to Dextran 40 and 70 reports to the united states food and drug administration 1969 to 2004
    Journal of Vascular Surgery, 2006
    Co-Authors: Craig Zinderman, Laurence Landow, Robert P Wise
    Abstract:

    Background Clinical Dextrans, such as Dextran 40 and Dextran 70, are associated with anaphylactoid reactions caused by Dextran-reactive immunoglobulin G antibodies. When infused immediately before clinical Dextrans, Dextran 1 significantly reduces the incidence of severe anaphylactoid reactions. The objective of the study was to describe the frequency and characteristics of reports submitted to the United States Food and Drug Administration (FDA) for anaphylaxis or anaphylactoid events after clinical Dextran administration. Methods We searched the FDA's Adverse Event Reporting System for reports associated with a clinical Dextran and describing anaphylaxis/anaphylactoid reactions. Our case definition for a probable anaphylaxis/anaphylactoid event required signs or symptoms from at least two body systems, with at least one sign or symptom being hypotension, vasodilation, or respiratory difficulty, and onset within 60 minutes. Other reports were considered possible cases if the reporter specifically described the reaction as anaphylaxis or an anaphylactoid reaction. Premier RxMarket Advisor provided estimates of total US hospitalizations with clinical Dextran or Dextran 1 administration from 2000 to 2004, based on discharge billing data from a sample of US hospitals. The IMS National Sales Perspective provided estimates of total doses of Dextrans sold in the United States from 1999 to 2004, based on volumes of Dextrans sold in a sample of retail and nonretail outlets. Results The FDA received 366 clinical Dextran adverse event reports from 1969 to 2004, of which 90 (24.6%) were anaphylaxis/anaphylactoid events. The ratio of hospitalizations where clinical Dextran was administered to hospitalizations where Dextran 1 was administered was 28.4:1. The expected ratio would be 1:1 if all clinical Dextran patients had received Dextran 1 pretreatment. The ratio of clinical Dextran doses sold to Dextran 1 doses sold in the United States was 38.6:1. Conclusions A high proportion of adverse event reports for clinical Dextrans described anaphylaxis or anaphylactoid reactions. Hospital discharge and product sales data suggest that Dextran 1 has not been used consistently before clinical Dextran administration in recent years. To reduce the risk of anaphylactoid reactions, physicians should consider routine administration of Dextran 1 before the infusion of a clinical Dextran.

Laura Cooling - One of the best experts on this subject based on the ideXlab platform.

  • another case of acute cardiopulmonary toxicity with cord blood infusion is Dextran the culprit
    Transfusion, 2012
    Co-Authors: Sung Choi, Sandra Hoffmann, Laura Cooling
    Abstract:

    Infusion-related adverse reactions associated with cord blood (CB) transplants are considered to be less frequent and less severe when compared to cryopreserved bone marrow or peripheral blood stem cells.1 The true incidence of these reactions is unknown, although it is reported that 30-60% of CB recipients are affected by infusion reactions.1,2 Recently, there have been six published reports of severe, life-threatening cardiopulmonary reactions associated with CB infusions (Table 1).3,4 A review by the National Marrow Donor Program (NMDP) and the Food and Drug Administration (FDA) of 13 serious CB-associated infusion reactions events showed that the majority of cases (92%; 12/13) involved infusion of at least one RBC-replete CB unit.3 As a consequence, the NMDP and FDA provided recommendations for thawing and washing RBC-replete CB units.3 We report a case of a seventh, cardiopulmonary reaction associated with the infusion of a RBC-depleted, CB unit diluted with human serum albumin (HSA)-Dextran 40.2 Table 1 Summary of Cord Blood Infusion Reactions with Cardiopulmonary Symptoms* The patient was a 16-year old, 46 kg, group O Caucasian female with acute biphenotypic leukemia. As part of a clinical trial, the patient was randomized to receive a 5/6 HLA-matched, double CB transplant (Table 1). Both CB units were RBC-depleted and cryopreserved in a solution containing 10% DMSO and 10% Dextran-40. After thawing, both CB units were diluted 1:3 with 5% HSA-8% Dextran 40 solution, for a combined final infusion volume of 411 ml and less than 3% DMSO per unit. The total transplant dose was 2.6 × 105 CD34 per kg and 5.7 × 107 TNC per kg of recipient weight. The patient was pre-medicated with acetaminophen, diphenhydramine, hydrocortisone, and mannitol per institutional clinical practice guidelines. Less than five minutes after starting the first CB unit, the patient experienced a severe anaphylactic reaction characterized by nausea, vomiting, dyspnea, wheezing, chest tightness, tachycardia, and tachypnea. The infusion was immediately stopped and the patient was treated with hydrocortisone, diphenhydramine, ativan, atrovent, and albuterol, and placed on 4 liters of oxygen by nasal cannula. After 10 minutes, the patient’s symptoms improved and the infusion of CB unit #1 was slowly restarted and subsequently completed within 60 minutes. After additional premedication, the patient received the second CB unit over 60 minutes. The second infusion was uneventful except for hypertension and a few hives two hours post-infusion. Both were successfully treated with additional antihistamine and anti-hypertensive medications. Diagnostic studies at the time of the infusion reaction showed a prolonged QTc (baseline 0.416 to 0.514 sec), elevated troponin (baseline <0.01 to 1.7 ng/mL) and B-type natriuretic peptide (baseline 110 to 592 pg/mL). An echocardiogram revealed regional hypokinesis of the basal half of the posterior two-thirds of the septum, with overall mildly depressed left ventricular systolic function. The patient had no evidence of electrolyte abnormalities, renal insufficiency, intravascular hemolysis or acute pulmonary changes. Pertinent EKG and laboratory studies returned to baseline within 48 hours and were attributed to transient myocardial ischemia. Our patient’s symptoms were consistent with a severe, anaphylactic reaction. We believe the reaction was precipitated by Dextran 40. Acute, severe reactions to Dextran 40 have a reported incidence of 1/2000 and can be associated with cardiac ischemia, pulmonary and renal injury.4,5 It is noteworthy that the majority (6/7) of cardiopulmonary infusion reactions reported to date were associated with CB units frozen and/or diluted in HSA-Dextran. As observed by Ma et al,4 reports of severe CB infusion reactions “coincide with the introduction of Dextran in cryopreservation”, and include more recent protocols for dilution or washing CB products in HSA-Dextran.2 Ongoing investigations into severe CB reactions should include the potential role of Dextran in such reactions, as well as possible prophylaxis with Dextran-1, a hapten known to significantly decrease the risk of Dextran reactions.4,5

Robert G Hahn - One of the best experts on this subject based on the ideXlab platform.

Edith Dellacherie - One of the best experts on this subject based on the ideXlab platform.

  • polymeric conjugates of gd3 diethylenetriaminepentaacetic acid and Dextran 1 synthesis characterization and paramagnetic properties
    Bioconjugate Chemistry, 1997
    Co-Authors: Richard Rebizak, Michel Schaefer, Edith Dellacherie
    Abstract:

    Macromolecular conjugates of Dextran and diethylenetriaminepentaacetic acid (DTPA), aimed to complex gadolinium, were synthesized to obtain contrast agents for nuclear magnetic resonance imaging with good paramagnetic properties and long intravascular persistence. These conjugates were prepared from Dextran 40 (Mn = 38 kg/mol and Mw = 43 kg/mol), which was first carboxymethylated. Then amines were introduced by reacting ethylenediamine with Dextran carboxylic acid groups in the presence of 2-ethoxy-1-(ethoxycarbonyl)-1,2-dihydroquinoline. DTPA was then covalently linked to aminated Dextran by using three different coupling procedures (DTPA bisanhydride, dicyclohexylcarbodiimide/N-hydroxysuccinimide, and isobutyl chloroformate). The different final products were compared in terms of DTPA contents, molecular masses, and sizes, and it was proved that the last synthesis step led to a small fraction of cross-linked chains as Mn was between 128 and 166 kg/mol and Mw between 332 and 371 kg/mol. In spite of t...