1.
Plasma trial: Pilot randomized clinical trial to determine safety and efficacy of plasma transfusions
Carson JL, Ness PM, Pagano MB, Philipp CS, Bracey AWJr, Brooks MM, Nosher JL, Hogshire L, Noveck H, Triulzi DJ
Transfusion. 2021
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Editor's Choice
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.
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.
2.
Photochemically treated fresh frozen plasma for transfusion of patients with acquired coagulopathy of liver disease
Mintz PD, Bass NM, Petz LD, Steadman R, Streiff M, McCullough J, Burks S, Wages D, Van Doren S, Corash L
Blood. 2006;107((9):):3753-60.
Abstract
An ex vivo photochemical treatment (PCT) process was developed to inactivate pathogens in fresh frozen plasma (PCT-FFP). A prospective, controlled, double-blinded, randomized study was conducted to evaluate the efficacy and safety of PCT-FFP compared with conventional FFP (C-FFP). Patients (n = 121) with acquired coagulopathy, largely due to liver disease, including hepatic transplantation, were transfused with either PCT-FFP or C-FFP for up to 7 days. Primary end points were changes in the prothrombin time (PT) and the partial thromboplastin time (PTT) in response to the first FFP transfusion. Secondary analyses compared changes in the PT and the PTT, factor VII levels, clinical hemostasis, blood component usage, and safety following FFP transfusions for up to 7 days. Following the first transfusion, correction in the PT and PTT adjusted for FFP dose and patient weight was not different. Changes in the PT were equivalent between treatment groups (P = . 002 by noninferiority). Equivalence was not demonstrated for changes in the PTT. Following multiple transfusions, correction of the PT and the PTT was similar between groups. No differences were observed in use of blood components, clinical hemostasis, or safety. These results suggest PCT-FFP supported hemostasis in the treatment of acquired coagulopathy similarly to conventional FFP.
3.
Multicentre clinical trial of low volume fresh frozen plasma therapy in acute pancreatitis
Leese T, Holliday M, Heath D, Hall AW, Bell PR
British Journal of Surgery. 1987;74((10):):907-11.
Abstract
Fresh frozen plasma (FFP) has been proposed as a specific therapy for acute pancreatitis. Reduced mortality encountered in an uncontrolled clinical study and a controlled experimental study may be attributable to replenishment by FFP of the naturally occurring antiprotease system. To investigate this potential therapy further, 202 patients presenting with acute pancreatitis were randomized to receive FFP (2 units daily for 3 days) or a similar volume of colloid control as part of their intravenous fluid therapy. Clinical progress was monitored and the major serum antiproteases (alpha 1-antiprotease and alpha 2-macroglobulin) were measured on days 1, 3 and 7. There was no significant difference between the two groups in terms of clinical outcome. alpha 1-Antiprotease levels rose significantly from day 1 to day 3 in both groups (P less than 0.0001) and remained elevated at day 7. alpha 1-Antiprotease is an acute phase protein in man and raised serum levels would be anticipated. FFP appears to have no effect on the magnitude of this rise. Serum alpha 2-macroglobulin levels were reduced in both groups on day 1 and continued to fall significantly from day 1 to day 3 in the colloid control group (P less than 0.005) whilst remaining substantially unaltered in patients receiving FFP (P = 0.6527). alpha 2-Macroglobulin plays a central role in the elimination of proteases during acute pancreatitis and the ability of relatively low volumes of FFP to reduce the fall in serum alpha 2-macroglobulin levels seen during the early stages of this disease may have therapeutic implications.