Point of Care Coagulation Testing in Patients Undergoing Major Surgery

Blood Loss, Surgical Clinical Trial

— POC-OP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00656396
• Other study ID #: KEK 232_06
• Secondary ID: 232_063200B0_122
• Status: Completed
• Phase: Phase 3
• First received: April 7, 2008
• Last updated: September 7, 2015
• Start date: May 2008
• Est. completion date: September 2011

Study information

• Verified date: September 2015
• Source: University of Bern
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Hemorrhage

Intervention

Device:
• Coagucheck XS Plus (Point of care monitor of coagulation intraoperative)
Coagucheck XS Plus® is used for intraoperative measurement of Prothrombin time

Procedure:
• Control Intervention
Standard care

Locations

Country	Name	City	State
Switzerland	University Hospital Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The relative risk to receive any FFP peri-operatively.		at post-operative discharge from hospital, estimated to be about 5 days after randomisation	No
Secondary	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	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes