Fresh frozen plasma in dengue patients with altered coagulation parameters: A randomized trial

Objective: To evaluate the effects of fresh frozen plasma transfusion in dengue patients. Methods: In this randomised, double blind, parallel, controlled trial, we included 200 patients with activated partial thromboplastin time (APTT) ≥40 seconds and platelet count ≤50×10 9 /L, randomly assigning them to experimental (10-15 mL/kg fresh frozen plasma transfusion) or control (standard management) groups. The principal aim was to assess the alteration in APTT at 24 hours among such patients. Between-group comparisons were restricted to the initial 24 hours post-intervention. Owing to ethical concerns regarding bleeding necessitating rescue therapy, the control group was removed, and subsequent follow-up (48 hours and 7 days post-transfusion) continued only for the experimental group. Results: Baseline characteristics in both groups were comparable. Mean age was (34.1±8.1) years and (36.1±7.8) years in the experimental and control groups, respectively. Within 24 hours, the experimental group had a significant drop in APTT compared to controls [median 38 (IQR 36-40) seconds vs. 44 (IQR 4046) seconds; P <0.001)]. Platelet count, mean haemoglobin, and haematocrit levels rose significantly in the experimental group ( P <0.001). Thirty (30%) control patients developed active bleeding, while none in the experimental group. Follow-up of the experimental arm showed significant sustained APTT reduction and platelet count increase. Conclusions: Fresh frozen plasma transfusion improves coagulation markers (reducing APTT and thrombocytopenia) at short-term (24 hours). Assessing use of fresh frozen plasma to prophylactically prevent active bleeding in severe dengue needs more studies with long-term follow-up. (ClinicalTrials.gov number, NCT06642493.)