Point of Care Coagulation Testing in Patients Undergoing Major Surgery (POC-OP)
Primary Purpose
Blood Loss, Surgical
Status
Completed
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
Coagucheck XS Plus (Point of care monitor of coagulation intraoperative)
Control Intervention
Sponsored by
About this trial
This is an interventional health services research trial for Blood Loss, Surgical focused on measuring Blood loss, Point of care monitoring, FFP, Major surgery, Prothrombin Time, Blood coagulation tests
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
Sites / Locations
- University Hospital Bern
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control
Intervention
Arm Description
Standard care
Point of care monitoring used
Outcomes
Primary Outcome Measures
The relative risk to receive any FFP peri-operatively.
Secondary Outcome Measures
Number of units of FFP received between randomization and post-operative discharge from hospital
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
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
The relative risk of overall mortality between randomization and post-operative discharge from hospital
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00656396
Brief Title
Point of Care Coagulation Testing in Patients Undergoing Major Surgery
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Bern
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss, Surgical
Keywords
Blood loss, Point of care monitoring, FFP, Major surgery, Prothrombin Time, Blood coagulation tests
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
228 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Standard care
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Point of care monitoring used
Intervention Type
Device
Intervention Name(s)
Coagucheck XS Plus (Point of care monitor of coagulation intraoperative)
Other Intervention Name(s)
Coagucheck XS Plus® Roche Diagnostics, Basel, Switzerland
Intervention Description
Coagucheck XS Plus® is used for intraoperative measurement of Prothrombin time
Intervention Type
Procedure
Intervention Name(s)
Control Intervention
Intervention Description
Standard care
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Greif, MD MME
Organizational Affiliation
Departement of Anesthesiology and Pain Therapy, Bern University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Natalie Urwyler, MD
Organizational Affiliation
Bern University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Jüni, PD Dr med
Organizational Affiliation
CTU Bern, Bern University Hospital, and Institute of Social and Preventive Medicine, University of Bern
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
19930626
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.
Results Reference
derived
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Point of Care Coagulation Testing in Patients Undergoing Major Surgery
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