Plasma trial: Pilot randomized clinical trial to determine safety and efficacy of plasma transfusions

Division of General Internal Medicine, Department of Medicine, Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey, USA. Division of Transfusion Medicine, Department of Pathology, Johns Hopkins Hospital, Baltimore, Maryland, USA. Department of Laboratory Medicine and Pathology, University of Washington, Seattle, Washington, USA. Division of Hematology, Department of Medicine, Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey, USA. Department of Pathology and Immunology, Baylor College of Medicine, Houston, Texas, USA. Department of Epidemiology and Biostatistics, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania, USA. Department of Radiology, Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey, USA. Division of Transfusion Medicine, Department of Pathology, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.

Transfusion. 2021

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PICO Summary

Population

Patients with cirrhosis (n= 57).

Intervention

Plasma transfusion (n= 27).

Comparison

No transfusion (n= 30).

Outcome

In the intention to treat analysis, there were 10 of 27 (38.5%) participants in the plasma arm with a post procedure INR <1.5 and one of 30 (3.6%) in the no treatment arm. The mean INR after receiving plasma transfusion was -0.24 (SD 0.26) lower than baseline. The change from pre-procedure haemoglobin level to lowest level within 2 days was -0.6 (SD = 1.0) in the plasma transfusion arm and -0.4 (SD = 0.6) in the no transfusion arm. Adverse outcomes were uncommon.
Abstract
BACKGROUND Plasma is frequently administered to patients with prolonged INR prior to invasive procedures. However, there is limited evidence evaluating efficacy and safety. STUDY DESIGN AND METHODS We performed a pilot trial in hospitalized patients with INR between 1.5 and 2.5 undergoing procedures conducted outside the operating room. We excluded patients undergoing procedures proximal to the central nervous system, platelet counts <40,000/μl, or congenital or acquired coagulation disorders unresponsive to plasma. We randomly allocated patients stratified by hospital and history of cirrhosis to receive plasma transfusion (10-15 cc/kg) or no transfusion. The primary outcome was change in hemoglobin concentration within 2 days of procedure. RESULTS We enrolled 57 patients, mean age 56.0, 34 (59.6%) with cirrhosis, and mean INR 1.92 (SD = 0.27). In the intention to treat analysis, there were 10 of 27 (38.5%) participants in the plasma arm with a post procedure INR <1.5 and one of 30 (3.6%) in the no treatment arm (p < .01). The mean INR after receiving plasma transfusion was -0.24 (SD 0.26) lower than baseline. The change from pre-procedure hemoglobin level to lowest level within 2 days was -0.6 (SD = 1.0) in the plasma transfusion arm and -0.4 (SD = 0.6) in the no transfusion arm (p = .29). Adverse outcomes were uncommon. DISCUSSION We found no differences in change in hemoglobin concentration in those treated with plasma compared to no treatment. The change in INR was small and corrected to less than 1.5 in minority of patients. Large trials are required to establish if plasma is safe and efficacious.
Study details
Language : eng
Credits : Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine