?????????Division of Emergency Medicine
RESTORE: REsuscitation of Shock from Traumatic HaemORrhagE?
A randomized controlled, multi-site adaptive trial to test the efficacy of Bioplasma Freeze Dried Plasma (FDP) compared to standard fluid therapy on prehospital participants with significant haemorrhage, following trauma.
Backgrou?nd
South Africa faces one of the highest injury loads and injury-mortality rates globally, yet it has few dedicated trauma centres. A critical issue in the treatment of trauma in South Africa is the scarcity of blood in both prehospital and emergency centre settings. Only 9% of South Africa's population are potential blood donors, leading to a severe shortage of blood availability. This shortage is exacerbated by the limited direct access to blood banks by South African Emergency Centres, presenting significant challenges for blood and blood product transfusions at these facilities. The initial care for traumatic shock patients in South Africa frequently occurs in Emergency Centres at district or regional hospitals, which only have a limited number of stored blood units that are replenished from off-site blood banks. These limitations, coupled with the cold chain logistical constraints associated with blood products and their short shelf life, highlight the need for alternative strategies to prolong traumatic shock patient survival until transfusion is possible.
Research Hypothes?is
To address this critical issue, we hypothesize that a freeze-dried plasma (FDP) solution, specifically Bioplasma FDP, is an ideal alternative due to its effect on blood coagulation. Bioplasma FDP is registered by the South African Health Products Regulatory Authority (SAHPRA) and is stable at ambient temperatures. It can be reconstituted for use on demand, allowing for timely delivery of plasma to bleeding patients and reducing suboptimal treatment with crystalloids.
Study Objectiv??es
Our primary objective is to establish the efficacy of Bioplasma FDP in reducing 24-hour mortality compared to standard fluid therapy. By assessing the impact of Bioplasma FDP, we hope to provide a viable solution to improve the survival rates of traumatic shock patients in South Africa, thereby addressing a critical need in emergency medical care.
Our dedicated research team is committed to exploring and validating the potential of Bioplasma FDP to revolutionize pre-hospital trauma care in South Africa. Through rigorous study and collaboration, we hope to contribute to the enhancement of emergency medical services and the overall health outcomes for trauma patients in the region.
Research tea?m
Principle investigator
- Dr Scott Mahoney, Division of Emergency Medicine, Stellenbosch 万博体育官网.
scott@sun.ac.za
Co-investigators:
- Dr Ismaeel Ebrahim, Division of Emergency Medicine, Stellenbosch 万博体育官网.
- Mr Wesley Craig, Division of Emergency Medicine, 万博体育官网 of Cape Town.
- A/prof Willem Stassen, Division of Emergency Medicine, 万博体育官网 of Cape Town.
- Dr Ni?l Van Hoving, Division of Emergency Medicine, Stellenbosch 万博体育官网.
Project Manager: Mrs Regina Mlobeli
Research Co-ordinator: Mrs Cheryl Fillis
Community Liaison officer: Mrs Nozizwe Makola
Administrative support: Mrs Leandrei Kipido?
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