Intent to Sole Source- Effects of Hemopure and Bioplasma FDP in patients who have experienced trauma
The U.S. Army Medical Research Acquisition Activity (USAMRAA) is seeking a clinical research network or consortium to conduct a multicenter clinical study in South Africa. This clinical study will examine the effects of Hemopure and Bioplasma FDP in patients who have experienced trauma. The study will be expected to enroll approximately 500 patients, which may include patients from public and/or private sector enrolling centers.
Market research was conducted in May- June 2017. A request for information (RFI) was posted on www.fbo.gov on 10 May 2017 with a response date of 08 June 2017. As a result of the RFI, one response was received from Stellenbosch University. The market research conducted included research conducted by the internet, review of product literature, review of previous similar procurements, research conducted by Joint Program Committee-6 (JPC-6) Combat Casualty Care , and the results of the RFI. The internet search was done using Google, Bing, and GSA Advantage. Vendors which can study the effects of Hemopure and Bioplasma FDP in patients who have experienced trauma are limited to South Africa due to the fact that few countries in the world have approved dried plasma for human use. South Africa is the only country that has approved Hemopure and has both an oxygen carrier and a dried plasma approved. Stellenbosch University's center for Evidence-Based Healthcare (CEBHC) offers robust statistical services for clinical projects, and are actively assisting with research on Hemopure and Bioplasma. Lead staff have been involved in a literature review and meta-analysis for Hemopure in previous studies.
As a result of this market research, Stellenbosch University appears to be the only source available to conduct this unique research for this requirement. Therefore, a determination to procure this research from Stellenbosch University on a sole source basis has been made.
Jennifer E. Tait, Email jennifer.e.tait.civ@mail.mil
