Poly Heme Trial DocumentsMethodist Hospital, Clarian Health Partners and Wishard Memorial Hospital, Wishard Health Services in Indianapolis, Indiana, in partnership with the Indiana University School of Medicine, are among 32 sites conducting a study testing PolyHemeŽ, a solution of chemically modified human hemoglobin in trauma patients who are suffering from massive blood loss. Because this study involves trauma patients in hemorrhagic shock, they are likely to be unconscious and unable to grant consent at the time of their injuries. This led the Food and Drug Administration to grant an exception from the requirement for informed consent (21 CFR 50.24) before the study began.
The Methodist and Wishard study initially was approved by the Indiana University-Purdue University Indianapolis (IUPUI) Institutional Review Board (IRB) in April 2004 and has been reviewed by the IRB every six months since that time. The IRB has oversight for human research at Methodist and Wishard and is responsible for the protection of people who participate in research studies.
The safety of those who participate in research studies is the top priority of all who conduct medical research at our institutions. The PolyHemeŽ trials at all 32 sites have been approved by each site's Institutional Review Board, and the data from all 32 sites has been reviewed by an Independent Data Monitoring Committee. IDMC recently reviewed the study data for the fourth time and issued the following statement:
"As has been reported by Northfield Laboratories regarding the final assessment of the interim data, including 500 randomized patients, there were no statistically significant trends or safety issues identified to warrant modification or other changes in the current protocol and patient recruitment. The IDMC conclusion is that completion of the trials is appropriate with completion of data sets and final analysis indicated."
The current PolyHemeŽ study at Methodist and Wishard is a Stage III clinical trial, which means that it has been tested in previous studies that examined its safety and its effectiveness when used to treat trauma patients who were suffering from massive blood losses. Researchers who conducted the Phase II trauma trials in which PolyHemeŽ was administered to rapidly bleeding patients at much larger doses of up to 20 units, or twice the normal adult blood volume, have reported that their data did not show any adverse effects of using PolyHemeŽ. (Source: Denver Health Medical Center web site, March 2006)
The IUPUI Institutional Review Board, which is responsible for research at both Methodist and Wishard hospitals, further states that recent national media accounts erroneously reported that the research community did not have knowledge of a PolyHemeŽ study in which two patients suffering from abdominal aortic aneurysm (ballooning in the wall of a major artery) died of heart attacks. The information from those studies was known and was determined not to be attributed to the use of PolyHemeŽ.
Researchers at Methodist and Wishard hospitals conducting the Phase III PolyHemeŽ study involving trauma patients have not reported any adverse effects in the trauma patients they have enrolled in the trial. All 32 sites conducting the study have reviewed and decided to continue enrolling participants. The study investigators anticipate that the trial will end in summer 2006 when the total number of patients outlined in the trial proposal has been reached.
For additional information about the study, click the PolyHemeŽ Trial Documents link at beginning of this news release. Those with further questions, please contact Jon Mills at Clarian Health, jmills3@clarian.org; Kimberly Harper at Wishard Health Services, kimberly.harper@wishard.edu or Pamela Perry at the IU School of Medicine, pperry@iupui.edu.
Bracelets to opt out of the PolyHemeŽ study can be obtained at the front desk of the Emergency Department at Wishard Memorial Hospital, located along Wishard Boulevard in Indianapolis, IN. Alternatively, bracelets can be mailed to you if you email your name and address to webmaster@clarian.org . (Clarian Health is handling all online requests for bracelets.)