CoagulopathyCPB-PLT-FNCTNCT02771223
Quantification of Thrombocytes Number and Function in Patients Undergoing Prolonged Extracorporeal Circulation
An observational study of Coagulopathy, run by Rambam Health Care Campus.
Trial summary
Prolonged extracorporeal circulation (ECC) for cardiac surgery results in coagulation abnormalities, most of which related to the direct, time dependent effect of the polymer tubing and the pump rollers on the thrombocytes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coagulopathy
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- May 2016to May 2017
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adults over 18 yo scheduled for prolonged cardiac surgery requiring ECC time over 3 hours,
Who may be able to join
- adults over 18 yo
- scheduled for prolonged cardiac surgery requiring ECC time over 3 hours
Who cannot join
- documented coagulopathy
- antiplatelet therapy other then aspirin
About this study
Official title: Quantification of Thrombocytes Number and Function in Patients Undergoing Prolonged Extracorporeal Circulation for Cardiac Surgery
Prolonged extracorporeal circulation (ECC) for cardiac surgery results in coagulation abnormalities, most of which related to the direct, time dependent effect of the polymer tubing and the pump rollers on the thrombocytes. Significant evidence demonstrates the effect of the duration of cardiopulmonary bypass on thrombocytes number and function, as well as on postoperative coagulopathy
Read the detailed description
Quantification of the effect of ECC duration on blood coagulation and platelet number and function
- Observational study on 20 patients undergoing prolonged ECC
- Blood sampling every 30 minutes for platelet count, platelet adhesion markers and coagulation studies
- Blood test to be performed in Rambam Blood Bank Laboratory
- Conditions
- Coagulopathy
- Medical subject headings
- Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study group | patients scheduled for prolonged cardiac surgery (over 3 hours anticipated ECC time) with no known coagulation disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Platelet function apoptosis markers
Platelet apoptosis by annexin V (Flow cytometry)
Measured: 1st sample - less than 10 minutes after induction of anesthesia, 2nd sample - less than 3 minutes after termination of CPB, 3rd sample - 10 minutes after protamine administration for heparin reversal, after termination of CPB
Change in Platelet function activation markers
Platelet activation by P-selectin (Flow cytometry)
Measured: 1st sample - less than 10 minutes after induction of anesthesia, 2nd sample - less than 3 minutes after termination of CPB, 3rd sample - 10 minutes after protamine administration for heparin reversal, after termination of CPB
Secondary outcomes (1)
Change in platelet count over time
Measured: Every 30 minutes - starting less than 10 minutes after induction of anesthesia, and for 7 hours or until termination of CPB and protamine administration - whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study startMay 2016
- Primary completionApr 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoagulopathyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Amit Lehavi MD FANZCA, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02771223
- Sponsor's protocol ID
- 15-645
- Acronym
- CPB-PLT-FNCT
- Status last verified
- May 2016
- First submitted
- 22 Apr 2016
- Last updated
- 17 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Thrombocytes Number and Function in Patients Undergoing Prolonged Extracorporeal Circulation for Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02771223
- Acronym / sponsor ID
- CPB-PLT-FNCT / 15-645
- Conditions
- Coagulopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Apr 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 13 May 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.
Prolonged extracorporeal circulation (ECC) for cardiac surgery results in coagulation abnormalities, most of which related to the direct, time dependent effect of the polymer tubing and the pump rollers on the thrombocytes. Significant evidence demonstrates the effect of the duration of cardiopulmonary bypass on thrombocytes number and function, as well as on postoperative coagulopathy
Detailed description
Quantification of the effect of ECC duration on blood coagulation and platelet number and function
- Observational study on 20 patients undergoing prolonged ECC
- Blood sampling every 30 minutes for platelet count, platelet adhesion markers and coagulation studies
- Blood test to be performed in Rambam Blood Bank Laboratory
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | –patients scheduled for prolonged cardiac surgery (over 3 hours anticipated ECC time) with no known coagulation disorders |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adults over 18 yo scheduled for prolonged cardiac surgery requiring ECC time over 3 hours,
Key inclusion criteria (2 listed)
- adults over 18 yo
- scheduled for prolonged cardiac surgery requiring ECC time over 3 hours
Key exclusion criteria (2 listed)
- documented coagulopathy
- antiplatelet therapy other then aspirin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Platelet function apoptosis markers
Time frame: 1st sample - less than 10 minutes after induction of anesthesia, 2nd sample - less than 3 minutes after termination of CPB, 3rd sample - 10 minutes after protamine administration for heparin reversal, after termination of CPB
Platelet apoptosis by annexin V (Flow cytometry)
Change in Platelet function activation markers
Time frame: 1st sample - less than 10 minutes after induction of anesthesia, 2nd sample - less than 3 minutes after termination of CPB, 3rd sample - 10 minutes after protamine administration for heparin reversal, after termination of CPB
Platelet activation by P-selectin (Flow cytometry)
1 secondary outcome
Change in platelet count over time
Time frame: Every 30 minutes - starting less than 10 minutes after induction of anesthesia, and for 7 hours or until termination of CPB and protamine administration - whichever comes first
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2016.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Coagulopathy, run by Rambam Health Care Campus.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 17 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Change in Platelet function apoptosis markers (time frame: 1st sample - less than 10 minutes after induction of anesthesia, 2nd sample - less than 3 minutes after termination of CPB, 3rd sample - 10 minutes after protamine administration for heparin reversal, after termination of CPB). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 May 2016.