Clinical and Biological Efficacy of Mirasol-treated Fresh Whole Blood for the Prevention of Transfusion-transmitted Malaria

Terumo BCT Europe N.V.0 个研究点目标入组 250 人开始时间: 2014年2月27日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•Age equal to or more than 18 years.
•Blood group O+.
•Hospitalized for at least 3 consecutive days after initial study transfusion.
•Require no more than 2 units of whole blood in the 3 days following randomization.
•Agree to return to the hospital for follow-up visits.
•Women of child bearing potential must have negative pregnancy test within 72 hours before randomization and must agree to practice a contraception regimen or agree to abstain from heterosexual intercourse during their study participation.
•Patient or legally authorized representative has given written informed consent.

•Symptoms of clinical malaria.
•Anti-malarial treatment within 7 days prior to randomization.
•Fever greater than 38.5°C.
•Massive bleeding expected to require more than 2 whole blood units within 3 days from randomization.
•Transfusion of a blood product within 1 month prior to randomization.
•Acute or chronic medical disorder that, in the opinion of the investigator, would impair the ability of the patient to receive protocol treatment.
•Previous treatment with other pathogen-reduced blood products.
•Females who are pregant.

发起方

Terumo BCT Europe N.V.