PolyHeme

09/01/2023 - "New analyses of the original trial database, including Fisher's exact test, examined impact of interval changes in total haemoglobin [THb], coagulation, fluid volumes administered and mortality on Day 1 in the Control (pre-hospital crystalloids, then blood after trauma centre admission) and PolyHeme arms of the trial. "
01/01/2003 - ", on 7 March 2003, the newswires quoted er, on 7 March 2003, the newswires quoted the CEO of Northfield Laboratories, stating that it is to administer 10 000 units of PolyHeme to 20 US trauma centres, following US FDA approval of a third phase III trial. "
01/01/2003 - "Up to 20 units of PolyHeme have been infused in US trials in trauma patients. "
08/01/1998 - "Forty-four trauma patients (33 male, 11 female) aged 19-75 years with an average Injury Severity Score (ISS) score of 21+/-10 were randomized to receive red cells (n = 23) or up to 6 U (300 g) of PolyHeme (n = 21) as their initial blood replacement after trauma and during emergent operations. "
01/01/2003 - "In March 2003, Northfield Laboratories announced that it had received clearance from the US FDA to proceed with a pivotal phase III trial evaluating the safety and efficacy of PolyHeme in improving patient survival when used to treat severely injured and bleeding trauma patients at the scene of injury and during ambulance transport to the hospital. "

09/01/2023 - "Coagulopathy exacerbated bleeding, anaemia, contributing to excess mortality in the PolyHeme arm. "
01/01/2003 - "In March 2003, Northfield Laboratories announced that it had received clearance from the US FDA to proceed with a pivotal phase III trial evaluating the safety and efficacy of PolyHeme in improving patient survival when used to treat severely injured and bleeding trauma patients at the scene of injury and during ambulance transport to the hospital. "
05/01/2006 - "(Evanston, IL) the trial is intended to evaluate the emergency use of PolyHeme, an oxygen-carrying resuscitative fluid that might prevent deaths from uncontrolled bleeding. "
01/01/2005 - "Clinical studies have shown that the peri-operative use of different HBOC (Hemopure, PolyHeme, Hemolink and HemAssist) can reduce the number of allogeneic RBC units and increase the avoidance rate of allogeneic transfusion in emergency bleeding, vascular, cardiac and non-cardiac surgery. "

10/01/2019 - "Greater anemia in subjects randomized to HBOC-201 was consistent with the relative efficacies of HBOC-201 and pRBCs to increase [THb] and may have contributed to more SAEs in the HBOC arm of HEM-0115 and greater long-term mortality in the PolyHeme trial."
04/01/2009 - "Human polymerized hemoglobin (PolyHeme) is a universally compatible oxygen carrier developed for use when red blood cells are unavailable and oxygen-carrying replacement is needed to treat life-threatening anemia. "
01/01/2009 - "Human polymerized hemoglobin (PolyHeme, Northfield Laboratories) is a universally compatible oxygen carrier developed to treat life-threatening anemia. "

05/01/2006 - "The protocol allows patients in hemorrhagic shock to be randomized between PolyHeme and saline in the field and, still without consent, randomized between PolyHeme and blood after arrival at an emergency department. "
06/01/2007 - "Significant attention has focused recently on RES in response to the trial of PolyHeme, a synthetic blood substitute, in trauma victims in hemorrhagic shock. "

01/01/2003 - "The IND is being developed to gain authorisation for the use of PolyHeme in patients in shock in remote battlefield settings, where red blood cells are not available. "
01/01/2017 - "This included the early trauma trials with HemAssist ® (BAXTER), Hemopure ® (BIOPURE) and PolyHeme ® (NORTHFIELD) for resuscitating hypotensive shock. "