Hemopure trials

Last Update Posted : May 16, Study Description. Detailed Description:. Arms and Interventions. Outcome Measures. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Inclusion Criteria: Subject is between the ages of 18 and Subject is an acceptable candidate for CABG.

Subject is scheduled for CABG without planned valvular repair or replacement by cardiopulmonary bypass. Subject signs informed consent Subject and the treating physician agree that subject can comply with all study procedures and follow-up visit at time of subject screening.

Active infection. History of prior stroke within last six months or history of prior stroke with residual neurological deficit. Transient Ischemic attack within last 6 months. Subject has a history of coagulopathy. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Search for terms. Save this study. Warning You have reached the maximum number of saved studies Listing a study does not mean it has been evaluated by the U. Federal Government. They chose to do this because blood is not available during the pre-hospital period and therefore the investigators thought the rapid delivery of HBOCs may have the greatest impact on survival in this setting. The rationale for the setting was the potential that these HBOCs could potentially save more lives than were lost in the emergent trauma setting and that they could significantly reduce the number of transfusions required by patients.

The FDA considers non-inferiority trials to be an acceptable study design and an acceptable marketing base for companies. If approved, a safe HBOC could change the way transfusion medicine is practiced and possibly reduce the morbidity and mortality of major surgical procedures and trauma.

HBOCs have the potential to reduce the incidence of inflammatory effects that result from trauma and transfusions, as well as preventing other problems associated with transfusions. However, trials to evaluate HBOCs have impacted the healthcare community at the junction where clinical practices and societal ethics meet.

For the Phase III trial that completed enrollment in December , PolyHeme enrolled its patients under a rule established by the FDA in , which waives informed consent in life-threatening conditions that must be handled quickly and when no better alternative is available. Investigators were required to educate their communities about the trial, through a variety of means.

Educating the public about the study was difficult for a variety of reasons, such as limited budgets and lack of guidelines for informing the public about the study. Another ethical criticism of the study was aimed at the study design. Patients in the PolyHeme group received their initial dose while in the ambulance, on the way to the hospital, whereas the control subjects were given a crystalloid solution.

However, once inside the ED, the control patients were given blood transfusions, while the PolyHeme patients continued to receive the test solution for the next 12 hours instead of blood. Unlike HBOCs, crystalloid fluids possess no oxygen carrying capacities and are used to simply maintain blood volume in trauma patients.

However, ethicists suggested the conditions allowing the waiver of informed consent was then violated once the patients reached the ED because the PolyHeme subjects failed to receive blood and instead continued to receive the test solution.

The need for an effective study design that both follows the scientific process and complies with community ethical standards is essential for the continued evaluation of any HBOC product. Society must determine how much risk the population will accept to save lives in the short term and to reduce mortality in the future. Inherent in any research endeavor is the problem of risk, and communities must weigh the possible benefits of the study against its possible risks.

However, these communities must be fully educated about the study and investigators must make every effort to inform the communities in which the study will be carried out about the trial. A recent meta-analysis published by Natanson et al. Further analyses indicate that these increased risks are consistent across patient population or specific product type. Because of these findings, Natanson et al. We suggest such studies must have a priori set endpoints and should be conducted by independent groups with FDA regulatory oversight.

The study also criticizes the lack of timely data put forth by the companies and the lack of published studies. Both Hemopure and Polyheme published studies only several years after the completion of their trials. Additionally, unpublished studies render a thorough IRB review of trials difficult. Natanson et al. Biopure responded to the Natanson et al. HemoTech was developed by HemoBioTech and derived from bovine hemoglobin. It underwent foreign pre-clinical and clinical testing in the late s and early s.

Sangart produces Hemospan, which is derived from human hemoglobin that has been chemically modified by attaching polyethylene glycol polymers its surface. Using a different approach to modifying hemoglobin, the U. Navy began researching liposome-encapsulated hemoglobin, or neo red cells. This unique oxygen carrier is being developed by Oxygenix, the company that produces Oxy, and is still in the experimental phase. Based on the results of clinical results, the efforts of Baxter, Northfield and Biopure to develop a safe and effective HBOC have not met with success to date.

Tables 2 — 4 demonstrate both the potential and the limitations of the HBOCs reviewed. Alarmingly, they also resulted in greater incidences of adverse side effects including pulmonary hypertension and cardiac depression. Our analysis and the conclusions of these studies suggest that the risks of using HBOCs currently exceed the benefits. It does not seem likely that any of these products will become successful in their present formulation until these unwanted effects are resolved.

Despite many setbacks in the development of its product, Biopure continues to work towards FDA approval. The quest for the Holy Grail of blood substitutes remains unfulfilled. To succeed, investigators must overcome scientific barriers, as well as federal regulation and social apprehension. However, if such a product can be developed, it will dramatically change both surgical and critical care medicine.

National Center for Biotechnology Information , U. Journal List Clinics Sao Paulo v. Clinics Sao Paulo. Author information Article notes Copyright and License information Disclaimer. Received Apr 21; Accepted May 6.

This article has been cited by other articles in PMC. Abstract The complications associated with acquiring and storing whole blood for transfusions have launched substantial efforts to develop a blood substitute.

Early History Research exploring alternatives to blood began approximately years ago. Table 1 Properties of hemoglobin based oxygen carriers. Open in a separate window. Table 2 HemAssist clinical trials. Table 3 PolyHeme clinical trials. Table 4 Hemopure clinical trials. Meta-analysis A recent meta-analysis published by Natanson et al. McCullough J. Progress toward a pathogen-free blood supply. Clin Infect Dis. Ross S, Jeter E. Emergency surgery, trauma, and massive transfusion.

Clinical Practice of Transfusion Medicine. New York: Churchill Livingstone; Allogeneic blood transfusion in the first 24 hours after trauma is associated with increased systemic inflammatory response system SIRS and death. Surgical Infections.

Blood transfusion: An independent risk factor for post injury multiple organ failure. Arch Surg. Upon administration, it immediately transports oxygen to tissues served by blood flow and, because of the relatively small molecular diameter, has the potential of transporting oxygen through constricted or partially blocked blood vessels via the movement of plasma through tissues in which red blood cell RBC flow is restricted.

Hemopure has an oxygen dissociation curve that is right-shifted with a P50 of 40 mmHg, compared to 27 mmHg for corpuscular hemoglobin. This property facilitates the uptake by and off-loading of oxygen from native red blood cells. When administered to anemic volunteers, Hemopure increased their pulmonary diffusion capacity, further demonstrating improved oxygen uptake.