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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by University of Bern.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Bern
ClinicalTrials.gov Identifier:
NCT00656396
First received: April 7, 2008
Last updated: September 14, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Blood Loss, Surgical
Device: Coagucheck XS Plus (Point of care monitor of coagulation intraoperative)
Procedure: Control Intervention
Phase 3

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

Resource links provided by NLM:


Further study details as provided by University of Bern:

Primary Outcome Measures:
  • The relative risk to receive any FFP peri-operatively. [ Time Frame: at post-operative discharge from hospital, estimated to be about 5 days after randomisation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of units of FFP received between randomization and post-operative discharge from hospital [ Time Frame: at post-operative discharge from hospital, estimated to be about 5 days after randomisation ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: at post-operative discharge from hospital, estimated to be about 5 days after randomisation ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: at post-operative discharge from hospital, estimated to be about 5 days after randomisation ] [ Designated as safety issue: Yes ]
  • The relative risk of overall mortality between randomization and post-operative discharge from hospital [ Time Frame: at post-operative discharge from hospital, estimated to be about 5 days after randomisation ] [ Designated as safety issue: Yes ]

Enrollment: 228
Study Start Date: May 2008
Estimated Study Completion Date: October 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Coagucheck XS Plus® Roche Diagnostics, Basel, Switzerland

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00656396

Locations
Switzerland
University Hospital Bern
Bern, Switzerland, 3010
Sponsors and Collaborators
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
  More Information

No publications provided by University of Bern

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. med. Natalie Urwyler, Departement for Anaesthesiology and Pain Therapy, University Hospital of Bern
ClinicalTrials.gov Identifier: NCT00656396     History of Changes
Other Study ID Numbers: KEK 232_06, 232_06 KEK Number, 3200B0_122461 SNF Number, 1295 Insel interne Nummer
Study First Received: April 7, 2008
Last Updated: September 14, 2011
Health Authority: Switzerland: Ethikkommission

Keywords provided by University of Bern:
Blood loss
Point of care monitoring
FFP
Major surgery
Prothrombin Time
Blood coagulation tests

Additional relevant MeSH terms:
Blood Loss, Surgical
Hemorrhage
Intraoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014