Factbites
 Where results make sense
About us   |   Why use us?   |   Reviews   |   PR   |   Contact us  

Topic: PolyHeme


Related Topics
FDA

In the News (Sat 6 Sep 08)

  
  PolyHeme - Wikipedia, the free encyclopedia
PolyHeme is a human hemoglobin-based temporary oxygen-carrying red blood cell substitute in development for the treatment of urgent, large volume blood loss in trauma and resultant surgical settings, with a particular focus on settings where blood is not immediately available.
PolyHeme is a solution of chemically modified human hemoglobin which simultaneously restores lost blood volume and hemoglobin levels and is designed for rapid, massive infusion.
Polyheme is produced by Northfield Laboratories Inc. and is currently in a Phase III trial.
en.wikipedia.org /wiki/Polyheme   (635 words)

  
 PolyHeme Background Materials   (Site not responding. Last check: 2007-11-02)
PolyHeme® is a unique human hemoglobin-based oxygen-carrying blood substitute in development for the treatment of urgent, large volume blood loss in trauma and surgical settings, with a particular focus on settings where blood is not immediately available.
PolyHeme® is the only blood substitute in development that has been rapidly and safely infused in clinical trials in sufficiently massive quantities to be useful in the treatment of urgent, large volume blood loss.
PolyHeme® is derived by lysing the red blood cells in outdated human blood and extracting the tetrameric hemoglobin protein which carries oxygen from inside.
www.hmc.psu.edu /clinicaltrials/studies/weblistings/polyheme/polyheme_background.htm   (980 words)

  
 Virginia Commonwealth University
Having already announced its interest in participating in the first national clinical research project to evaluate the usefulness of PolyHeme, VCU Medical Center is one of 20 Level-1 trauma centers in the country that may study the oxygen-carrying blood substitute and its ability to increase survival in critically injured and bleeding patients.
PolyHeme is a universally compatible oxygen-carrying fluid composed of chemically modified hemoglobin derived from human blood.
PolyHeme is designed to treat hemorrhagic shock where blood transfusion is required but blood is not available.
www.vcu.edu /uns/Releases/2004/may/051104.html   (781 words)

  
 deseretnews.com | Hospitals testing synthetic blood
PolyHeme, because of its hemoglobin base, can be placed intravenously into the trauma patient at the scene of the accident and can pump oxygen into the blood stream.
PolyHeme can be administered to patients who have lost a large amount of blood and are in shock, patients who are at least 18 years old and patients who have sustained severe injuries.
PolyHeme is manufactured by Northfield Laboratories, Inc. of Evanston, Ill., and is in its third phase of study.
deseretnews.com /dn/view/0,1249,600141548,00.html   (653 words)

  
 News and Events   (Site not responding. Last check: 2007-11-02)
PolyHeme® will be administered on a random basis to patients at the scene of the injury or in the ambulance en route to the emergency room.
Manufactured by the Evanston, Illinois-based, Northfield Laboratories Inc., PolyHeme® is the first blood substitute of its kind to undergo U.S. trial where treatment begins at the scene of the injury and in the ambulance.
In addition, PolyHeme® has the potential of becoming an ideal resuscitative fluid because it supports life in the absence of red blood cells, reduces the risk of disease transmission, does not cause transfusion reactions, and allows for rapid, massive infusion.
www.etsu.edu /calendars/calendars_news.asp?EventID=3303   (542 words)

  
 UC Polyheme Project
The University of Cincinnati Medical Center is one of a select number of Level I trauma centers in the U.S. chosen to participate in a groundbreaking national clinical trial to evaluate the safety and efficacy of PolyHeme®, an oxygen-carrying blood substitute, in increasing survival of critically injured and bleeding patients.
Since blood is not presently carried in ambulances, the use of PolyHeme in these settings has the potential to address a critical unmet medical need for an oxygen-carrying solution where blood is currently not available.
In this trial it may not be possible to obtain informed consent from the patient or a legally authorized representative due to the urgency of the situation and the extent of the injuries.
www.ucpolyheme.org   (531 words)

  
 Army To Partner in Trauma Blood Substitute Study - U.S. Department of Defense Transformation Story   (Site not responding. Last check: 2007-11-02)
PolyHeme, is a universally compatible, immediately available, oxygen-carrying resuscitative fluid designed for use in urgent blood loss when blood is not immediately available.
PolyHeme has previously been studied in the hospital setting in trauma patients demonstrating an improved survival, according to the Journal of the American College of Surgeons, October 2002.
PolyHeme is manufactured by Northfield Laboratories Inc., of Evanston, Ill. It requires no cross matching, making it immediately available and compatible with all blood types, and has an extended shelf-life of more than 12 months.
www.defenselink.mil /transformation/articles/2005-07/ta071905a.html   (525 words)

  
 Boston.com / News / Local / Mass. / Substitute blood trial worries ethicists
Because severely injured patients are usually either in shock or unconscious, the small Illinois company that makes PolyHeme has received a waiver from the federal rule requiring that people give their consent to the experiment, which could be carried out at up to 20 hospitals nationwide.
Most recently, the death rate among 171 patients who received rapid PolyHeme infusions was less than half the rate of those who didn't receive blood, according to a study in the Journal of the American College of Surgeons.
PolyHeme is derived from human hemoglobin, the molecules in red blood cells that carry oxygen, and is chemically treated to last 12 months, making it practical to carry on an ambulance.
www.boston.com /news/local/massachusetts/articles/2004/02/21/substitute_blood_trial_worries_ethicists   (876 words)

  
 PolyHeme FAQ
It is hoped that infusing PolyHeme® will reduce the mortality rates in comparison to salt water infusion when started at the scene of injury and in comparison to blood during the first 12 hours in the hospital.
PolyHeme® is highly purified to reduce the risk of viral disease transmission.
Past studies have shown that PolyHeme® carries as much oxygen as blood, has not caused organ damage, keeps people alive who have lost all of their own blood, and can be infused up to two times a person’s entire blood volume.
irb.ucsd.edu /notices/polyheme/FAQs.htm   (1008 words)

  
 PolyHeme Trial Underway in Wyandotte, Douglas and Leavenworth Counties   (Site not responding. Last check: 2007-11-02)
During this study Polyheme® is compared to standard of care, saline (salt water) in the pre-hospital setting and blood in the hospital.
The treatment under study, PolyHeme®, is a universally compatible, immediately available, oxygen-carrying resuscitative fluid designed for use in urgent blood loss when blood is not immediately available and following in the hospital where blood is available but is not necessarily free of certain side effects.
Its product, PolyHeme, has been rapidly infused in clinical trials in sufficiently large quantities to be considered well tolerated and may be useful in the treatment of large volume blood loss in trauma and surgical settings.
www.kumc.edu /news/publish/article_00660.shtml   (726 words)

  
 The Cincinnati Post
PolyHeme, made from purified hemoglobin, is an oxygen-carrying solution that will help keep patients alive when blood isn't available, Locasto said.
The major difference between saline and PolyHeme, is that saline doesn't carry oxygen, and is used merely as a means to keep fluid in the circulatory system, hence increasing blood pressure.
PolyHeme has previously been studied in hospital situations, leading to approval of the urban ambulance trial, pending the community notification, Locasto said.
www.cincypost.com /2004/02/04/blood020404.html   (809 words)

  
 Substitute proves effective in emergencies - January 12, 2005
The medical center plans to take part in a study to use PolyHeme, a blood substitute made from real blood that would otherwise be discarded, to treat critical patients.
Since the blood used in PolyHeme undergoes a filtration process to rid it of viral elements, Cherry said it is considered safe, and there have been no known infections in other trials.
PolyHeme will not be used in anyone under 18, in pregnant women or anyone with a severe brain injury or unsurvivable injury.
archive.dailyitem.com /archive/2005/0112/fea/stories/07fea.htm   (624 words)

  
 || DukeMedNews || PolyHeme Trial to Begin Monday at Duke University Hospital
Federal regulations require "waiver of consent" study investigators to hold public meetings to educate the community in which the trial is to be conducted; answer questions from the community about the study; and obtain feedback from citizens regarding the proposed clinical trial.
The blood substitute PolyHeme is capable of efficient delivery of oxygen to patients, and it creates less risk of disease transmission, and has a shelf-life of 12 months as opposed to the 42-day shelf life of whole blood, the researchers said.
PolyHeme is a universally compatible, oxygen-carrying resuscitative fluid designed for use in urgent blood-loss situations where blood is not immediately available.
news.mc.duke.edu /news/article.php?id=9141   (1197 words)

  
 UPHS Bloodless Medicine & Surgery: Newsletter - PolyHeme, An Alternative to Blood Transfusion
PolyHeme lasts in the body for only 72 hours, but could serve as a temporary solution for critically injured patients who do not have immediate access to stored blood, or who refuse to receive standard blood transfusions.
PolyHeme has a shelf life of approximately 100 days, which is more than half the shelf life of donated blood.
Also, PolyHeme is universally compatible, which means that no blood typing is required prior to its use and it can be used immediately.
www.pennhealth.com /bloodless/newsletter/fall03/poly.html   (392 words)

  
 NEWS - HEALTH - Comcast.net
He said the study was stopped, not for safety concerns, but because enrollment was declining and the company wanted to focus on trauma research.
Testing Polyheme against blood should be done separately in patients who can give consent or who have family members who can consent, wrote King and University of Hawaii ethicist Ken Kipnis and Philadelphia anesthesiologist Dr. Robert Nelson.
Many briefings also did not mention the previous Polyheme study, and withholding that information was unethical, the ethicists said.
www.comcast.net /news/health/index.jsp?cat=HEALTHWELLNESS&fn=/2006/03/01/336169.html   (832 words)

  
 KY Kernel   (Site not responding. Last check: 2007-11-02)
PolyHeme, an experimental blood replacement made by Northfield Labs Inc. of Indiana, came under fire in a Wall Street Journal article published in late February.
PolyHeme is an oxygen-carrying blood substitute derived from blood, where the oxygen-carrying chemical, hemoglobin, is extracted and then put into a form where it not only carries oxygen but also replaces blood volume.
In contrast, UK's PolyHeme study takes place with trauma patients who have lost blood volume and need to have it replaced, both to maintain blood pressure and to carry oxygen to the body to help the patient survive.
www.kykernel.com /media/paper305/news/2006/03/23/CampusNews/Uk.Continues.Study.Despite.Controversy-1713846.shtml?norewrite200606240401&sourcedomain=www.kykernel.com   (538 words)

  
 Paramedics praising PolyHeme - Campus News   (Site not responding. Last check: 2007-11-02)
PolyHeme is derived from hemoglobin, the chemical that carries oxygen in the blood and gives it its red color.
The only side effect that has been reported with PolyHeme was a mild red rash around where it is administered, which does not itch and disappears after a few hours.
PolyHeme is being used in Fayette County, as well as in several surrounding counties within a certain distance of UK Chandler Medical Center.
media.www.kykernel.com /media/storage/paper305/news/2006/01/17/CampusNews/Paramedics.Praising.Polyheme-1370753.shtml?sourcedomain=www.kykernel.com&MIIHost=media.collegepublisher.com   (487 words)

  
 Evaluating the ability of an investigational blood substitute PolyHeme®
The blood substitute, PolyHeme®, is universally compatible with all blood types and can be given to trauma victims in the field, whereas blood typically is not.
PolyHeme is manufactured by Northfield Laboratories Inc. of Evanston, Ill. Data from the trial is monitored nationally by an independent data monitoring committee (IDMC).
The IDMC is a group of experts, not associated with Northfield, responsible for periodically evaluating the safety data from the study and making recommendations relating to the continuation or modification of the study to minimize any identified risks to patients.
www.rxpgnews.com /research/hematology/article_2439.shtml   (761 words)

  
 Northfield CEO: PolyHeme May Need More Trials
Northfield is seeking approval of PolyHeme for use in trauma situations where patients face life-threatening blood loss and do not have access to regular blood.
Instead, all patients in Northfield's study were given PolyHeme, then their results were compared to published, historical reports of results of patients in similar situations.
At this point, investors seem to be shrugging off the risks of a lengthy delay in PolyHeme's development, and are instead happy with the management changes and promises of more openness about the company's operations.
www.thestreet.com /pf/tech/adamfeuerstein/10034355.html   (1042 words)

  
 Norfolk Fire Polyheme Study
Actually getting to a point where a person may receive PolyHeme® requires the patient to meet a group of inclusion as well as exclusion criteria before they are enrolled in the study.
Once enrolled, the patient may still not receive the PolyHeme®, dependent on what group the person is randomized to.
The PolyHeme® program in Norfolk is set to run approximately one year and will attempt to capture data on at least 30 patients.
tidewater.vaems.org /archive/Polyheme.htm   (552 words)

  
 The Tonganoxie Mirror: County residents part of blood study
PolyHeme, which replaces lost blood volume and hemoglobin, or red blood cells, can be given to a patient at the scene of an accident or on the way to the hospital.
Trials of PolyHeme have shown that in worst-case scenarios, patients who were losing all of their own blood received as many as 20 units of PolyHeme and survived, Moncure said.
Certainly (with PolyHeme) there is the opportunity to save some of the people on the 45 minutes to an hour who are bleeding until they can get to a trauma center and receive care.
www.tonganoxiemirror.com /section/local/storypr/8408   (684 words)

  
 newsobserver.com | Blood product draws doubts
PolyHeme, which is made from proteins extracted from donated blood, offers a possible treatment for emergency trauma patients who lose a lot of blood.
The current trial aims to discover whether PolyHeme, which has a shelf life of 12 months and can carry oxygen, is a safe and effective alternative.
Northfield believes PolyHeme could be especially valuable in rural areas, where patients may live far from hospitals, and for treating soldiers in battle.
www.newsobserver.com /102/story/410675.html   (778 words)

Try your search on: Qwika (all wikis)

Factbites
  About us   |   Why use us?   |   Reviews   |   Press   |   Contact us  
Copyright © 2005-2007 www.factbites.com Usage implies agreement with terms.