PolyHeme

PolyHeme was a proposed temporary oxygen-carrying blood substitute made from human hemoglobin for emergency treatment of trauma situations where large volumes of blood are lost, with emphasis on situations where fresh blood for transfusion is not readily available. It originally began as a military project following the Vietnam War and was being developed by Northfield Laboratories, Inc. until clinical trial data showed Polyheme patients suffered increased morbidity, suspected as being due to vasoconstrictive side effects. Operations were shut down in 2009.

PolyHeme was a proposed temporary oxygen-carrying blood substitute made from human hemoglobin for emergency treatment of trauma situations where large volumes of blood are lost, with emphasis on situations where fresh blood for transfusion is not readily available. It originally began as a military project following the Vietnam War and was being developed by Northfield Laboratories, Inc. until clinical trial data showed Polyheme patients suffered increased morbidity, suspected as being due to vasoconstrictive side effects. Operations were shut down in 2009. Lists of the participating hospitals can be found at Artificial Blood Experiment: Is Your City Participating? and ClinicalTrials.gov. Northfield -- Jacobs Engineering contract. Northfield's Mt. Prospect, IL facility purchase. Phase III PolyHeme Trial Completion Application for Fast-Track status sent to FDA. Preliminary Top-Line Results of Phase III study. Participating Trauma Centers. Federal Regulation 21CFR 50.24 allowing Exemption of Informed Consent. PolyHeme's patent. U.S. FDA's Community Disclosure of Institutional Review Boards. U.S. Senator Dick Durbin's $3.5 million Defense Appropriation for PolyHeme Development. A participating Trauma Center's discussion on the above so-called "controversy". Northfield Laboratories Releases Summary Observations from Its Elective Surgery Trial ie. "the ANH trial". Northfield Laboratories Strongly Disputes Wall Street Journal Story Conclusions. Northfield Laboratories Statement Regarding Its Pivotal Phase III Trial, in response to critics about its waiver of informed consent status. Northfield Labs' response to ABC 20/20 segment regarding patient safety and waiver of informed consent status. (archive) Fake Blood, Real Controversy PolyHeme - and the Newest Plastic Bracelet PolyHeme Lawsuit (archive)

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