Cardiopulmonary BypassNCT02979158
Preoperative Dual Antiplatelet Therapy: Platelet Function and Influence of Cardiopulmonary Bypass
A study testing CPB Low Dose and CPB High Dose in people with Cardiopulmonary Bypass and Platelet Disorder, run by Umeå University at 1 site in Sweden.
Trial summary
Patients admitted for coronary artery bypass surgery taking antiplatelet medicine have an increased risk for bleeding. Present study aims to compare the platelet function in two patient groups using different types of heart-lung machine methods. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cardiopulmonary Bypass, Platelet Disorder, Bleeding Disorder
- What is being tested?
- CPB Low Dose and CPB High Dose
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2016to 24 Jan 2018
- Phase
- Interventional
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients accepted for coronary bypass surgery with dual preoperative antiplatelet therapy suspended less than 4 days prior to surgery
Who cannot join
- Abnormal coagulation verified from preoperative assessments, platelet count <100 000, Warfarin medication and renal insufficiency (GFR < 60 ml/min)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Cardiopulmonary Bypass on Platelet Function in Patients With Preoperative Dual Antiplatelet Therapy:
Patients admitted for coronary artery bypass surgery taking antiplatelet medicine have an increased risk for bleeding.
Present study aims to compare the platelet function in two patient groups using different types of heart-lung machine methods.
It is assumed that one of the methods is superior verified by sensitive methods of testing platelet function.
Read the detailed description
Taking antiplatelet medication before cardiac surgery increases the risk for bleeding.
The surgical procedure and the use of a heart-lung machine may disturb the function of platelets, why measures to protect the existing function of platelets are of prime concern.
The present study aims to compare how two types of heart-lung machine methods influence platelet function in two groups of patients.
The platelet function will be tested before, during and after surgery by the use of two independent methods.
- Conditions
- Cardiopulmonary Bypass, Platelet Disorder, Bleeding Disorder, Platelet Dysfunction Due to Drugs
- Being tested
- CPB Low Dose, CPB High Dose
- Medical subject headings
- Blood Platelet Disorders, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPB Low DoseProcedure or surgery
Performing CPB with low dose heparin and coated equipment
CPB High DoseProcedure or surgery
Performing CPB with high dose heparin and uncoated equipment
| Study group | Role | What they receive |
|---|---|---|
| CPB Low Dose | Experimental | Conduct of cardiopulmonary bypass using a low heparin dose verified by the activated clotting time at 250 s Receives: Procedure: CPB Low Dose |
| CPB High Dose | Experimental | Conduct of cardiopulmonary bypass using a high heparin dose verified by the activated clotting time at 480 s Receives: Procedure: CPB High Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of platelet function following cardiopulmonary bypass using platelet aggregometry
Included aggregometry tests: Multiplate and Rotem Platelet
Measured: Test of platelet function will be analysed on arrival to the operating room, post cardiopulmonary bypass and on day 1 in the intensive care unit based on the area under the curve depited from the two employed aggremometers
Secondary outcomes (1)
Postoperative bleeding
Blood loss 24 hrs post surgery
Measured: Postoperative bleeding 24 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2016 (estimated)
- Study startNov 2016
- Primary completion24 Jan 2018
- Study completion24 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiopulmonary BypassStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Ulf Näslund, MD PhD, Principal investigator, Department of Publich Health and Clinical Medicin, Umeå University, SwedenMagnus Hedström, MD, Study director, Heart Centre Umeå University Hospital Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02979158
- Sponsor's protocol ID
- DAPTUMU-123
- Status last verified
- Nov 2016
- First submitted
- 21 Nov 2016
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: Data will be shared after reviewing final results after study completion at this site and through publication in a scientific journal.
Publications
Olsson A, Alfredsson J, Hakansson E, Svedjeholm R, Berglund J, Berg S. Protamine reduces whole blood platelet aggregation after cardiopulmonary bypass. Scand Cardiovasc J. 2016;50(1):58-63. doi: 10.3109/14017431.2015.1099720. Epub 2015 Oct 20.
PubMed 26402229Mishra PK, Thekkudan J, Sahajanandan R, Gravenor M, Lakshmanan S, Fayaz KM, Luckraz H. The role of point-of-care assessment of platelet function in predicting postoperative bleeding and transfusion requirements after coronary artery bypass grafting. Ann Card Anaesth. 2015 Jan-Mar;18(1):45-51. doi: 10.4103/0971-9784.148321.
PubMed 25566711Mollnes TE, Videm V, Christiansen D, Bergseth G, Riesenfeld J, Hovig T. Platelet compatibility of an artificial surface modified with functionally active heparin. Thromb Haemost. 1999 Sep;82(3):1132-6.
PubMed 10494777
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Cardiopulmonary Bypass on Platelet Function in Patients With Preoperative Dual Antiplatelet Therapy:
- ClinicalTrials.gov ID
- NCT02979158
- Acronym / sponsor ID
- DAPTUMU-123
- Conditions
- Cardiopulmonary Bypass, Platelet Disorder, Bleeding Disorder, Platelet Dysfunction Due to Drugs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Nov 2016
- Primary completion
- 24 Jan 2018 (actual)
- Study completion
- 24 Jan 2018 (actual)
- First posted
- 1 Dec 2016 (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.
Patients admitted for coronary artery bypass surgery taking antiplatelet medicine have an increased risk for bleeding.
Present study aims to compare the platelet function in two patient groups using different types of heart-lung machine methods.
It is assumed that one of the methods is superior verified by sensitive methods of testing platelet function.
Detailed description
Taking antiplatelet medication before cardiac surgery increases the risk for bleeding.
The surgical procedure and the use of a heart-lung machine may disturb the function of platelets, why measures to protect the existing function of platelets are of prime concern.
The present study aims to compare how two types of heart-lung machine methods influence platelet function in two groups of patients.
The platelet function will be tested before, during and after surgery by the use of two independent methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPB Low Dose | Experimental | Procedure: CPB Low DoseConduct of cardiopulmonary bypass using a low heparin dose verified by the activated clotting time at 250 s |
| CPB High Dose | Experimental | Procedure: CPB High DoseConduct of cardiopulmonary bypass using a high heparin dose verified by the activated clotting time at 480 s |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients accepted for coronary bypass surgery with dual preoperative antiplatelet therapy suspended less than 4 days prior to surgery
Key exclusion criteria (1 listed)
- Abnormal coagulation verified from preoperative assessments, platelet count <100 000, Warfarin medication and renal insufficiency (GFR < 60 ml/min)
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 |
|---|---|---|
| CPB Low DosePerforming CPB with low dose heparin and coated equipment | Procedure or surgery | CPB Low Dose |
| CPB High DosePerforming CPB with high dose heparin and uncoated equipment | Procedure or surgery | CPB High Dose |
Primary outcome
Assessment of platelet function following cardiopulmonary bypass using platelet aggregometry
Time frame: Test of platelet function will be analysed on arrival to the operating room, post cardiopulmonary bypass and on day 1 in the intensive care unit based on the area under the curve depited from the two employed aggremometers
Included aggregometry tests: Multiplate and Rotem Platelet
1 secondary outcome
Postoperative bleeding
Time frame: Postoperative bleeding 24 hrs
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 29 Mar 2018.
- Background: PubMed 26402229Olsson A, Alfredsson J, Hakansson E, Svedjeholm R, Berglund J, Berg S. Protamine reduces whole blood platelet aggregation after cardiopulmonary bypass. Scand Cardiovasc J. 2016;50(1):58-63. doi: 10.3109/14017431.2015.1099720. Epub 2015 Oct 20.
- Background: PubMed 25566711Mishra PK, Thekkudan J, Sahajanandan R, Gravenor M, Lakshmanan S, Fayaz KM, Luckraz H. The role of point-of-care assessment of platelet function in predicting postoperative bleeding and transfusion requirements after coronary artery bypass grafting. Ann Card Anaesth. 2015 Jan-Mar;18(1):45-51. doi: 10.4103/0971-9784.148321.
- Background: PubMed 10494777Mollnes TE, Videm V, Christiansen D, Bergseth G, Riesenfeld J, Hovig T. Platelet compatibility of an artificial surface modified with functionally active heparin. Thromb Haemost. 1999 Sep;82(3):1132-6.
- Individual participant dataSharing planned: Undecided. Data will be shared after reviewing final results after study completion at this site and through publication in a scientific journal.
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Recruiting
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Cardiac Surgery, Cardiopulmonary Bypass
Recruiting
Optimized Cardiopulmonary Bypass Flow Strategy Based on Ideal Body Weight in Obese Patients Undergoing Cardiac Surgery
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RecruitingObservational study
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A Study to Understand How Cardiac Surgery-associated Acute Kidney Injury Develops in Participants Who Undergo Heart Surgery With the Use of Heart-lung Machine
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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.
Ulf Näslund, MD PhD principal investigator
Department of Publich Health and Clinical Medicin, Umeå University, Sweden
Magnus Hedström, MD study director
Heart Centre Umeå University Hospital Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPB Low Dose and CPB High Dose in people with Cardiopulmonary Bypass and Platelet Disorder, run by Umeå University at 1 site in Sweden.
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 1 inclusion and 1 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 29 Mar 2018. 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 Sweden. 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.
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?
Assessment of platelet function following cardiopulmonary bypass using platelet aggregometry (time frame: Test of platelet function will be analysed on arrival to the operating room, post cardiopulmonary bypass and on day 1 in the intensive care unit based on the area under the curve depited from the two employed aggremometers). 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 NCT02979158, which also lists 3 linked publications.
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 29 Mar 2018.