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

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 À0.24 (SD 0.26) lower than baseline. The change from pre-procedure hemoglobin level to lowest level within 2 days was À0.6 (SD = 1.0) in the plasma transfusion arm and À0.4 (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.

Safety of COVID‐19 convalescent plasma: A definitive systematic review and meta‐analysis of randomized controlled trials

“…Although it is considered a new blood product, the high safety profile of CCP emerging from this systematic review is not surprising as it shares the same biological origin of standard FFP, whose clinical safety is well known since many years. 65,66 Such finding is however noteworthy and adds another important piece to the understanding of the role of CCP in COVID-19 management. According to the current literature evidence, 4,67,68 we can therefore conclude that early CCP usage is not only effective in preventing COVID-19 progression, but may have little to no impact on the risk of any adverse events.…”

Fresh Frozen Plasma Transfusion before Invasive Procedure in Patients with Cirrhosis and Severe ‎Coagulopathy‎ ‎

“…The In patients with INR between 1.5 and 1.9, many physicians have a concept that plasma transfusion has no role. However, in patients with INR 2.0-2.5, other physicians always decide to transfuse plasma [13]. The range of INR eligible for this trial was ≥ 2, but this has substantially reduced the number of eligible patients for enrolment.…”

Indications for the Use of Therapeutic Plasma in Adult Patients

“…Based on the described pathophysiological background and in agreement with a recent British guideline, the German hemotherapy guideline, in general, supports a restrictive approach to substitute therapeutic plasma or other hemostatic agents in patients with stable, i.e., nonbleeding, liver failure. So, the prophylactic administration of therapeutic plasma before diagnostic interventions or minor surgery (central venous catheter, thoracocentesis, or paracentesis) is not recommended [ 40 , 41 , 42 , 43 ]. The only exception from this may be the placement of an external ventricular drainage for intracranial pressure monitoring as it was recommended by European Association for the Study of the Liver (EASL) for patients with acute liver failure [ 44 ].…”