Featured Research

from universities, journals, and other organizations

Blood Substitute's Effectiveness And Safety Addressed In Large Clinical Trial

Date:
June 13, 2008
Source:
University of California - Los Angeles
Summary:
A blood substitute's effectiveness and safety was addressed in a large Phase III clinical trial by academic and industry researchers.

A predicted shortfall of over 4 million units of blood worldwide is driving the need to develop an alternative to red blood cells.

Academic and industry researchers participated in a Phase III multi-center clinical trial and found that use of a blood substitute was relatively safe in patients under 80 years old who have a moderate need for transfusion, up to the equivalent of three units of regular blood.

Published in the June edition of the Journal of Trauma, this study is the first Phase III trial to compare a blood substitute to regular blood and was conducted at 46 sites in the United States, Europe and South Africa.

"The majority of patients who received the blood substitute did well," said Dr. Jonathan Jahr, study lead author and professor of clinical anesthesiology, David Geffen School of Medicine at UCLA.

The six-week study involved 688 patients, ages 18 and older, undergoing elective orthopedic surgery, since these procedures often have a high need for blood transfusions. Patients initially received either one unit of blood, which is about a pint, or received an equivalent one unit or 65 grams of a blood substitute product called HBOC-201, a hemoglobin-based oxygen carrier, manufactured by Biopure Corporation.

Made from a bovine source after multiple purifications, HBOC-201 can be kept at room temperature for up to three years and does not need to be matched to one's blood type.

Patients could receive up to 10 units of the blood substitute during a six-day period, or for those in the study group receiving regular blood, unlimited transfusions. Subjects were evaluated daily and six weeks post-operatively.

"We found that we eliminated the need for blood transfusions for 59 percent of the 350 patients who received the blood substitute," said Dr. Colin F. Mackenzie, study author, professor and former director, National Study Center for Trauma & EMS, University of Maryland School of Medicine. "The blood substitute worked best in those under 80 years old with a moderate transfusion need."

For those over age 80 with more acute health issues and higher transfusion needs, the blood substitute did not work as well as blood. As a result, many of these patients were crossed over into the group to receive regular blood.

A number of adverse events involving the cardiac and central nervous systems were found in 21 of these older patients who received the blood substitute. Analysis revealed that the issues were due to advanced age, heart failure or possibly under-treatment.

"For this specific older acute patient population, we suggest using a blood substitute only if blood is not available. These patients also need to be carefully monitored for vascular volume status and avoidance of fluid overload," said Dr. A. Gerson Greenburg, study author and vice president, medical affairs, Biopure Corporation.

Mortality rates in both study groups with moderate transfusion needs were low -- at one percent. The higher transfusion need groups reported a five percent mortality rate in the blood substitute group and a three percent rate in the group receiving regular blood, which are comparable according to researchers.

Many of the less serious adverse effects seen in the overall group receiving the blood substitute were due to temporary expected physiologic effects of this class of drugs which can include skin discoloration interpreted as jaundice, elevation of blood pressure and the rise of levels in the enzymes troponin and lipase.

"Although these temporary side effects didn't lead to any clinical problems in most patients, these should be studied in future trials," said Jahr.

The majority of the 350 patients in the study arm using the blood substitute received an average of five or less units. A total of 338 patients receiving blood were given less than 2 units on average.

"This product has a definite place where blood is not an option, such as in patients whose immune system attacks red blood cells or those whose religion forbids blood transfusions and in situations where blood is not available," said Mackenzie.

The next stage of research will include studies in military and trauma situations and further studies in anemia and ischemia.

Biopure, the manufacturer of HBOC-201, funded the study. Jahr has served as the principal investigator on one additional Biopure study and owns Biopure stock. He also has been a researcher on other blood substitutes at other companies. Jahr has a large independent lab that has published over 80 manuscripts, reviews and abstracts on blood substitutes independent of any company or company funding. Mackenzie has been a consultant for Biopure and has received funding as a site principal investigator to conduct this study.

Additional authors include L. Bruce Pearce, Ph.D. and Arkadiy Pitman, Biopure Corporation.


Story Source:

The above story is based on materials provided by University of California - Los Angeles. Note: Materials may be edited for content and length.


Journal Reference:

  1. Jahr et al. HBOC-201 as an Alternative to Blood Transfusion: Efficacy and Safety Evaluation in a Multicenter Phase III Trial in Elective Orthopedic Surgery. The Journal of Trauma Injury Infection and Critical Care, 2008; 64 (6): 1484 DOI: 10.1097/TA.0b013e318173a93f

Cite This Page:

University of California - Los Angeles. "Blood Substitute's Effectiveness And Safety Addressed In Large Clinical Trial." ScienceDaily. ScienceDaily, 13 June 2008. <www.sciencedaily.com/releases/2008/06/080610165104.htm>.
University of California - Los Angeles. (2008, June 13). Blood Substitute's Effectiveness And Safety Addressed In Large Clinical Trial. ScienceDaily. Retrieved September 23, 2014 from www.sciencedaily.com/releases/2008/06/080610165104.htm
University of California - Los Angeles. "Blood Substitute's Effectiveness And Safety Addressed In Large Clinical Trial." ScienceDaily. www.sciencedaily.com/releases/2008/06/080610165104.htm (accessed September 23, 2014).

Share This



More Health & Medicine News

Tuesday, September 23, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Liberia Pleads for Help to Fight Ebola

Liberia Pleads for Help to Fight Ebola

AP (Sep. 22, 2014) Liberia's finance minister is urging the international community to quickly follow through on pledges of cash to battle Ebola. Bodies are piling up in the capital Monrovia as the nation awaits more help. (Sept. 22) Video provided by AP
Powered by NewsLook.com
Ebola Doctor Says Border Controls Critical

Ebola Doctor Says Border Controls Critical

AP (Sep. 22, 2014) A Florida doctor who helped fight the expanding Ebola outbreak in West Africa says the disease can be stopped, but only if nations quickly step up their response and make border control a priority. (Sept. 22) Video provided by AP
Powered by NewsLook.com
Global Ebola Aid Increasing But Critics Say It's Late

Global Ebola Aid Increasing But Critics Say It's Late

Newsy (Sep. 21, 2014) More than 100 tons of medical supplies were sent to West Africa on Saturday, but aid workers say the global response is still sluggish. Video provided by Newsy
Powered by NewsLook.com
Sierra Leone in Lockdown to Control Ebola

Sierra Leone in Lockdown to Control Ebola

AP (Sep. 21, 2014) Sierra Leone residents remained in lockdown on Saturday as part of a massive effort to confine millions of people to their homes in a bid to stem the biggest Ebola outbreak in history. (Sept. 20) Video provided by AP
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:

Strange & Offbeat Stories


Health & Medicine

Mind & Brain

Living & Well

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins