Clinical trial NCT00656396: Point of Care Coagulation Testing in Patients Undergoing Major Surgery
Official title: Does Point of Care Coagulation Testing Reduce the Transfusion of Non-erythrocyte Blood Products in Patients Undergoing Major Surgery? A Randomized-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Blood Loss, Surgical
Keywords: Blood loss
Point of care monitoring
FFP
Major surgery
Prothrombin Time
Blood coagulation tests
Lead sponsor: University of Bern
Sponsor class: OTHER
First posted: 2008-04-11
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Bleeding is a frequent complication during surgery. The peri-operative administration of blood products, including packed red blood cells, thrombocytes and fresh frozen plasma (FFP), is often deemed necessary. Therefore the transfusion of allogenic blood products mandates strategies to optimize the clinical decision to transfuse. The decision to administer FFP is usually made in the absence of any data. Point of care testing of prothrombin time ensures that a major parameter of coagulation is readily available. The test is fast, easy to perform, inexpensive and may enable physicians to rationally determine the need for FFP. Objective of the study is to determine the effectiveness of point of care coagulation testing of prothrombin time to reduce the administration of FFP.

Detailed description: Background: Bleeding is a frequent complication during surgery. The peri-operative administration of blood products, including packed red blood cells, thrombocytes and fresh frozen plasma (FFP), is often deemed necessary. Beside the expenses of blood products these products carry risks of infection, allergic reaction and immune-modulation. Therefore the transfusion of allogenic blood products mandates strategies to optimize the clinical decision to transfuse. Bleeding during surgery is a dynamic process; it can happen within minutes and result not only in major blood loss, but also in coagulation aberrations. The indication for a transfusion should be based on reliable coagulation studies. Traditional coagulation studies require up to 1 hour. Therefore, the decision to administer FFP is usually made in the absence of any data. Point of care testing of prothrombin time ensures that a major parameter of coagulation is readily available in the operation theatre within 3 minutes. It is fast, easy to perform, inexpensive and may enable physicians to rationally determine the need for FFP. Objective: To determine the effectiveness of point of care coagulation testing of prothrombin time to reduce the administration of FFP. Methods: 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 transplant) with an estimated blood loss during surgery exceeding 20% of the calculated normal total blood volume or a requirement of FFP according to the judgment of treating surgeons or anesthesiologists. Patients will be randomized to usual care plus point of care coagulation testing or usual care alone without point of care testing. Primary endpoint will be the relative risk to receive any FFP peri-operatively. Significance: Point of care coagulation testing in the operation theatre may reduce the administration of fresh frozen plasma considerably, which in turn may decrease costs and complications usually associated with the administration of allogenic blood products.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 90 years
* Major surgery
* Estimated blood loss during surgery \> 20% of individual blood volume of 70ml per kg body weight
* Patients requiring FFP

Exclusion Criteria:

* Known hereditary coagulopathy
* Liver transplant
* Cardiac surgery
* Pregnancy
* Preoperative hemoglobin \<100g/l
* Abnormal coagulation studies before surgery
* Active treatment with drugs inhibiting coagulation or platelet function

Primary outcomes:
measure: The relative risk to receive any FFP peri-operatively.
timeFrame: at post-operative discharge from hospital, estimated to be about 5 days after randomisation
Secondary outcomes:
measure: Number of units of FFP received between randomization and post-operative discharge from hospital
timeFrame: at post-operative discharge from hospital, estimated to be about 5 days after randomisation
measure: The relative risk of major in-hospital bleeding defined as bleeding event requiring an extension of hospitalization, reoperation due to bleeding, bleeding resulting in hemorrhagic shock or death
timeFrame: at post-operative discharge from hospital, estimated to be about 5 days after randomisation
measure: The relative risk of an APTC event (non-fatal myocardial infarction, non-fatal stroke, cardiovascular death, or death of unknown cause) between randomization and post-operative discharge from hospital
timeFrame: at post-operative discharge from hospital, estimated to be about 5 days after randomisation
measure: The relative risk of overall mortality between randomization and post-operative discharge from hospital
timeFrame: at post-operative discharge from hospital, estimated to be about 5 days after randomisation
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University Hospital Bern
Study officials:
affiliation: Departement of Anesthesiology and Pain Therapy, Bern University Hospital
name: Robert Greif, MD MME
role: STUDY_DIRECTOR
affiliation: Bern University Hospital
name: Natalie Urwyler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CTU Bern, Bern University Hospital, and Institute of Social and Preventive Medicine, University of Bern
name: Peter Jüni, PD Dr med
role: STUDY_CHAIR
References:
citation: Urwyler N, Trelle S, Theiler L, Juni P, Staub LP, Luyet C, Alberio L, Stricker K, Greif R. 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. Trials. 2009 Nov 23;10:107. doi: 10.1186/1745-6215-10-107.