Point of Care Coagulation Testing in Patients Undergoing Major Surgery

NCT ID: NCT00656396

Last Updated: 2015-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 228 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2011-09-30

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.

Conditions

Blood Loss, Surgical

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Control

Standard care

Group Type: ACTIVE_COMPARATOR

Control Intervention

Intervention Type: PROCEDURE

Standard care

Intervention

Point of care monitoring used

Group Type: EXPERIMENTAL

Coagucheck XS Plus (Point of care monitor of coagulation intraoperative)

Intervention Type: DEVICE

Coagucheck XS Plus® is used for intraoperative measurement of Prothrombin time

Interventions

Coagucheck XS Plus (Point of care monitor of coagulation intraoperative)

Coagucheck XS Plus® is used for intraoperative measurement of Prothrombin time

Intervention Type: DEVICE

Control Intervention

Standard care

Intervention Type: PROCEDURE

Other Intervention Names

Coagucheck XS Plus® Roche Diagnostics, Basel, Switzerland

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bern

OTHER

Sponsor Role: lead

Responsible Party

Departement for Anaesthesiology and Pain Therapy, University Hospital of Bern

Principal Investigators

Robert Greif, MD MME

Role: STUDY_DIRECTOR

Departement of Anesthesiology and Pain Therapy, Bern University Hospital

Natalie Urwyler, MD

Role: PRINCIPAL_INVESTIGATOR

Bern University Hospital

Peter Jüni, PD Dr med

Role: STUDY_CHAIR

CTU Bern, Bern University Hospital, and Institute of Social and Preventive Medicine, University of Bern

Locations

University Hospital Bern

Bern, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 19930626 (View on PubMed)

Other Identifiers

232_06

Identifier Type: OTHER

Identifier Source: secondary_id

3200B0_122461

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1295

Identifier Type: OTHER

Identifier Source: secondary_id

KEK 232_06

Identifier Type: -

Identifier Source: org_study_id