Does point of care prothrombin time measurement reduce the transfusion of fresh frozen plasma in patients undergoing major surgery? The POC-OP randomized-controlled trial

Abstract

BackgroundBleeding is a frequent complication during surgery. The intraoperative administration of blood products, including packed red blood cells, platelets and fresh frozen plasma (FFP), is often live saving. Complications of blood transfusions contribute considerably to perioperative costs and blood product resources are limited. Consequently, strategies to optimize the decision to transfuse are needed.Bleeding during surgery is a dynamic process and may result in major blood loss and coagulopathy due to dilution and consumption. The indication for transfusion should be based on reliable coagulation studies. While hemoglobin levels and platelet counts are available within 15 minutes, standard coagulation studies require one hour. Therefore, the decision to administer FFP has to be made in the absence of any data. Point of care testing of prothrombin time ensures that one major parameter of coagulation is available in the operation theatre within minutes. It is fast, easy to perform, inexpensive and may enable physicians to rationally determine the need for FFP.Methods/DesignThe objective of the POC-OP trial is to determine the effectiveness of point of care prothrombin time testing to reduce the administration of FFP. It is a patient and assessor blind, single center randomized controlled parallel group trial in 220 patients aged between 18 and 90 years undergoing major surgery (any type, except cardiac surgery and liver transplantation) with an estimated blood loss during surgery exceeding 20% of the calculated total blood volume or a requirement of FFP according to the judgment of the physicians in charge. Patients are randomized to usual care plus point of care prothrombin time testing or usual care alone without point of care testing. The primary outcome is the relative risk to receive any FFP perioperatively. The inclusion of 110 patients per group will yield more than 80% power to detect a clinically relevant relative risk of 0.60 to receive FFP of the experimental as compared with the control group.DiscussionPoint of care prothrombin time testing in the operation theatre may reduce the administration of FFP considerably, which in turn may decrease costs and complications usually associated with the administration of blood products.Trial registrationNCT00656396

The role of point‐of‐care platelet function testing in predicting postoperative bleeding following cardiac surgery: a systematic review and meta‐analysis

“…Following removal of duplicates and screening of titles and abstracts against our inclusion criteria, 23 full‐text titles were selected for assessment. Nine trials (Table ) were identified for quantitative analysis, and the following titles were excluded: no randomised controlled trials ; desmopressin trials ; no blood transfusion management algorithm used ; non‐cardiac surgery ; and paediatric patients (Fig. ).…”

Using patient management as a surrogate for patient health outcomes in diagnostic test evaluation

“…False negative test results are not expected to have a major detrimental effect, because a negative test would shift rather than replace the clinical threshold for transfusion, so patients who clearly demonstrate abnormal bleeding would still receive blood products regardless of a negative test result. However, it was also concluded that these assumptions of the impact of the test on patient management and subsequent outcomes needed confirmation, and a trial investigating these questions is underway [ 18 ].…”

The three‐pillar matrix of patient blood management

“…The focus is on rapid assessment of the underlying cause(s) and the presenting ‘status’ of the three pillars of PBM, especially in relationship to the haemostatic system. This is where point of care testing and real time management of the three pillars is increasing being shown to lead to minimizing allogeneic blood transfusion and better clinical outcomes . In many of these circumstances, minimizing allogeneic blood transfusion results in better clinical outcomes in terms of less lung injury and multi‐organ failure, reduced assisted ventilation, lower infection rates, fewer and shorter ICU admissions as well as shorter lengths of hospital stay.…”