Why the study?
Is Dextran 40 safe and effective compared to alternatives for volume expansion, pump priming, and antithrombotic prophylaxis?
Is Dextran 40 safe and effective compared to alternatives for volume expansion, pump priming, and antithrombotic prophylaxis?
Dextran 40 is not recommended for its approved uses due to the lack of comparative data establishing its safety and efficacy over available alternatives, alongside significant risks of fatal side effects.
Warrants caution with Dextran 40 given risks without proven superiority; leaves open rigorous comparative trials versus alternatives.
Dextran 40 has been approved for use as a volume expander for shock of any cause and as a pump primer for extracorporeal circulation. Since its approval, no critical studies that clearly show its superiority over other solutions have been published. It is being used increasingly for prophylactic antithrombotic therapy in surgical patients who are at high risk of thromboembolic complications, and comparative studies show it to be as effective as warfarin for this purpose. But its dangerous and potentially fatal side effects should be known to the potential user. These include anaphylaxis and other allergic reactions, hypervolemia, renal failure, and a bleeding diathesis. These side effects may be overlooked because they can be easily ascribed to the condition for which the drug is being given. Because other equally effective drugs are available for all the approved uses of dextran 40, we cannot recommend this drug until we have comparative data that establish it as being at least as safe and effective as the alternatives.
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Joann L. Data (1974) studied this question.
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