Blood Loss, SurgicalPhase 3POC-OPNCT00656396
Point of Care Coagulation Testing in Patients Undergoing Major Surgery
A Phase 3 study testing Coagucheck XS Plus (Point of care monitor of coagulation intraoperative) in people with Blood Loss, Surgical, run by University of Bern at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Blood Loss, Surgical
- What is being tested?
- Coagucheck XS Plus (Point of care monitor of coagulation intraoperative)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2008to Sep 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Coagucheck XS Plus (Point of care monitor of coagulation intraoperative), Control Intervention
- Keywords
- Blood loss, Point of care monitoring, FFP, Major surgery, Prothrombin Time, Blood coagulation tests
- Medical subject headings
- Blood Loss, Surgical, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coagucheck XS Plus (Point of care monitor of coagulation intraoperative)Device
Also called Coagucheck XS Plus® Roche Diagnostics, Basel, Switzerland
Coagucheck XS Plus® is used for intraoperative measurement of Prothrombin time
Control InterventionProcedure or surgery
Standard care
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Standard care Receives: Procedure: Control Intervention |
| Intervention | Experimental | Point of care monitoring used Receives: Device: Coagucheck XS Plus (Point of care monitor of coagulation intraoperative) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The relative risk to receive any FFP peri-operatively.
Measured: at post-operative discharge from hospital, estimated to be about 5 days after randomisation
Secondary outcomes (4)
Number of units of FFP received between randomization and post-operative discharge from hospital
Measured: 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
Measured: 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
Measured: 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
Measured: at post-operative discharge from hospital, estimated to be about 5 days after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2008 (estimated)
- Study startMay 2008
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood Loss, SurgicalStudies of the same condition, open and under way.
- More trials run by University of BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Investigators
- Robert Greif, MD MME, Study director, Departement of Anesthesiology and Pain Therapy, Bern University HospitalNatalie Urwyler, MD, Principal investigator, Bern University HospitalPeter Jüni, PD Dr med, Study chair, CTU Bern, Bern University Hospital, and Institute of Social and Preventive Medicine, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00656396
- Sponsor's protocol ID
- KEK 232_06
- Other IDs
- 232_06, 3200B0_122461, 1295
- Acronym
- POC-OP
- Status last verified
- Sep 2015
- First submitted
- 7 Apr 2008
- Last updated
- 9 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 19930626
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00656396
- Acronym / sponsor ID
- POC-OP / KEK 232_06
- Conditions
- Blood Loss, Surgical
- Keywords
- Blood loss, Point of care monitoring, FFP, Major surgery, Prothrombin Time, Blood coagulation tests
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 11 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Procedure: Control InterventionStandard care |
| Intervention | Experimental | Device: Coagucheck XS Plus (Point of care monitor of coagulation intraoperative)Point of care monitoring used |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- Known hereditary coagulopathy
- Liver transplant
- Cardiac surgery
- Pregnancy
- Preoperative hemoglobin <100g/l
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coagucheck XS Plus (Point of care monitor of coagulation intraoperative)Also: Coagucheck XS Plus® Roche Diagnostics, Basel, SwitzerlandCoagucheck XS Plus® is used for intraoperative measurement of Prothrombin time | Device | Intervention |
| Control InterventionStandard care | Procedure or surgery | Control |
Primary outcome
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
4 secondary outcomes
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2015.
- Derived from this study: PubMed 19930626Urwyler 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Greif, MD MME study director
Departement of Anesthesiology and Pain Therapy, Bern University Hospital
Natalie Urwyler, MD principal investigator
Bern University Hospital
Peter Jüni, PD Dr med study chair
CTU Bern, Bern University Hospital, and Institute of Social and Preventive Medicine, University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Coagucheck XS Plus (Point of care monitor of coagulation intraoperative) in people with Blood Loss, Surgical, run by University of Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00656396, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2015.