Point of Care Coagulation Testing in Patients Undergoing Major Surgery (POC-OP)

Does Point of Care Coagulation Testing Reduce the Transfusion of Non-erythrocyte Blood Products in Patients Undergoing Major Surgery? A Randomized-Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Blood Loss, Surgical
• Intervention / Treatment: Procedure: Control Intervention; Device: Coagucheck XS Plus (Point of care monitor of coagulation intraoperative)

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.

• Study Type: Interventional
• Enrollment (Actual): 228
• Phase: Phase 3

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • University Hospital Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Standard care	Procedure: Control Intervention; Standard care
Experimental: Intervention; Point of care monitoring used	Device: Coagucheck XS Plus (Point of care monitor of coagulation intraoperative); Coagucheck XS Plus® is used for intraoperative measurement of Prothrombin time; Other Names: Coagucheck XS Plus® Roche Diagnostics, Basel, Switzerland

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The relative risk to receive any FFP peri-operatively.	at post-operative discharge from hospital, estimated to be about 5 days after randomisation

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of units of FFP received between randomization and post-operative discharge from hospital	at post-operative discharge from hospital, estimated to be about 5 days after randomisation
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	at post-operative discharge from hospital, estimated to be about 5 days after randomisation
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	at post-operative discharge from hospital, estimated to be about 5 days after randomisation
The relative risk of overall mortality between randomization and post-operative discharge from hospital	at post-operative discharge from hospital, estimated to be about 5 days after randomisation

Collaborators and Investigators

• Sponsor: University of Bern
• Investigators: Study Director: Robert Greif, MD MME, Departement of Anesthesiology and Pain Therapy, Bern University Hospital; Principal Investigator: Natalie Urwyler, MD, Bern University Hospital; Study Chair: Peter Jüni, PD Dr med, CTU Bern, Bern University Hospital, and Institute of Social and Preventive Medicine, University of Bern

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: April 7, 2008
• First Submitted That Met QC Criteria: April 10, 2008
• First Posted (Estimate): April 11, 2008

Study Record Updates

• Last Update Posted (Estimate): September 9, 2015
• Last Update Submitted That Met QC Criteria: September 7, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: FFP; Blood loss; Major surgery; Prothrombin Time; Point of care monitoring; Blood coagulation tests
• Additional Relevant MeSH Terms: Pathologic Processes; Intraoperative Complications; Hemorrhage; Blood Loss, Surgical
• Other Study ID Numbers: KEK 232_06; 232_06 (Other Identifier: KEK); 3200B0_122461 (Other Grant/Funding Number: SNF); 1295 (Inselspital)