CAPE TOWN, South Africa— Experts from the US Army Institute of Surgical Research and Emergency Medicine and South Africa’s Stellenbosch University (SU) have embarked on a large, multi-institutional clinical trial to evaluate the use of synthetic blood-products for the resuscitation of trauma victims before they arrive at a hospital.
The Institute of Surgical Research is coordinating through the US Africa Command Science department and under an agreement implemented by the US Embassy Pretoria, Office of Defense Coordination on Research, Development, Testing and Evaluation (RDT&E) in 2016.
The San Antonio based center, which focuses on combat casualty care, will be partner with Stellenbosch University’s Division of Emergency Medicine Faculty of Medicine and Health Sciences.
Other universities involved in the clinical trial include the University of Cape Town, KwaZulu-Natal), Witwatersrand and Pretoria. These entities collectively represent the body of academic emergency medicine in South Africa.
All parties met in Cape Town for the first major planning session 27-30 November at Stellenbosch University’s Tygerburg Multi-Center, Prospective, Randomized Clinical Study of Bioplasma Freeze Dried Plasma and Hemopure for use in Treatment of Trauma Patients with Significant Haemorrhage.
“We want to build a strategy that actually works effectively regarding hemopure, bioplasma from accountability flow to legitimate sources and dosing according to clinical protocol,” explained Nicky Kramer, Senior Research Pharmacist at the University of Cape Town Clinical Research Centre.
Hemopure is indicated for the treatment of adult surgical patients who are acutely anemic according to the South African National Health Act 2003.
The study will evaluate the use of the hemoglobin-based oxygen carrier Hemopure (HbO2 Therapeutics LLC) together with Bioplasma FDP (National Biologics Institute), freeze-dried plasma, to resuscitate trauma victims prior to arrival at a hospital emergency room.
Hemoglobin is a naturally occurring protein responsible for transporting oxygen through the blood. Plasma is the colorless fluid part of the blood that contains proteins that make blood clot.
“This is an 8.2 million project with over 6 million already allocated. Our primary objective in establishing the efficacy of a combination of Hemopure and Bioplasma on 24-hour mortality compared to standard fluid therapy,” said Dr Anthony Pusateri, PhD, the Director of Research for the Institute of Surgical Research.
Trauma is the leading cause of death and disability among young adults, which is often due to severe blood loss. Bleeding following trauma causes 1.5 million deaths a year worldwide.
South Africa has a high burden of trauma, especially amongst young adults.
Improvements in survival and better clinical outcomes from trauma result from early diagnosis, rapid bleeding control, and the early deployment of ambulances to rapidly transport patients to advanced medical care.