Platelet Function TestsNCT02833025
Point-of-care Assessment of Thrombin Generation and Platelet Function in Children Requiring Cardiopulmonary Bypass
An observational study of Platelet Function Tests and Thrombin Generation Tests, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
Coagulopathy after cardiopulmonary bypass (CPB) is associated with increased morbidity and mortality. Clot formation and clot stability are important factors in coagulation and hemostasis. As such platelet dysfunction and impaired thrombin generation play a central role in bleeding after cardiac surgery. Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Platelet Function Tests, Thrombin Generation Tests, Perioperative Coagulopathy
- What is being tested?
- Thrombin generation and Platelet Function Testing
- Type of treatment
- Medical device
- How many people
- 130 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2018to 1 Dec 2020
- 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 Up to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged ≤5 years undergoing cardiac surgery with cardiopulmonary bypass
Who may be able to join
- Age ≤5 years
- Undergoing cardiac surgery with cardiopulmonary bypass
Who cannot join
- Non-english speaking parents/care-givers
- Refusal to consent
- Extracorporeal membrane oxygenation (ECMO) or ventricular assist device prior to surgery
- Therapeutic heparin use (unfractionated or low molecular weight) in the immediate preoperative period (<12 hr)
- Weight <3 kg
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Point-of-care Assessment of Thrombin Generation and Platelet Function in Children Undergoing Cardiac Surgery With Cardiopulmonary Bypass
Coagulopathy after cardiopulmonary bypass (CPB) is associated with increased morbidity and mortality. Clot formation and clot stability are important factors in coagulation and hemostasis. As such platelet dysfunction and impaired thrombin generation play a central role in bleeding after cardiac surgery. The primary objective of this study is to evaluate the relationship between point-of-care determined platelet function and thrombin generation and postoperative bleeding in infants and young children undergoing cardiac surgery with cardiopulmonary bypass adjusting for clinically important confounding factors.
- Being tested
- Thrombin generation and Platelet Function Testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thrombin generation and Platelet Function TestingDevice
Point-of-care testing of thrombin generation, platelet function, and rotational thromboelastometry
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative chest tube blood loss
Measured: 24hr
Secondary outcomes (9)
Postoperative chest tube blood loss
Measured: 6hr
Postoperative chest tube blood loss
Measured: 12hr
Transfusion of blood products
Measured: 24hr
All-cause mortality
Measured: within 30 days
Length of hospital stay
Measured: through study completion, an average of less than one month
Length of ICU stay
Measured: within 30 days
Duration of mechanical ventilation
Measured: within 30 days
Inotropes
Duration of inotropic support
Measured: within 30 days
Kidney injury
Acute kidney injury
Measured: within 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study start1 Dec 2018 (estimated)
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet Function TestsStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Synapse B.V. Research Institute, University of Maastricht
- Responsible party
- Principal investigator, James O'Leary, The Hospital for Sick Children
- Investigators
- James D O'Leary, MBBCh, MM, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02833025
- Sponsor's protocol ID
- 1000053849
- Status last verified
- May 2018
- First submitted
- 5 Jul 2016
- Last updated
- 9 May 2018
- 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 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point-of-care Assessment of Thrombin Generation and Platelet Function in Children Undergoing Cardiac Surgery With Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT02833025
- Acronym / sponsor ID
- 1000053849
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Synapse B.V. Research Institute, University of Maastricht
- Study start
- 1 Dec 2018 (estimated)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 14 Jul 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.
Coagulopathy after cardiopulmonary bypass (CPB) is associated with increased morbidity and mortality. Clot formation and clot stability are important factors in coagulation and hemostasis. As such platelet dysfunction and impaired thrombin generation play a central role in bleeding after cardiac surgery. The primary objective of this study is to evaluate the relationship between point-of-care determined platelet function and thrombin generation and postoperative bleeding in infants and young children undergoing cardiac surgery with cardiopulmonary bypass adjusting for clinically important confounding factors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged ≤5 years undergoing cardiac surgery with cardiopulmonary bypass
Key inclusion criteria (2 listed)
- Age ≤5 years
- Undergoing cardiac surgery with cardiopulmonary bypass
Key exclusion criteria (5 listed)
- Non-english speaking parents/care-givers
- Refusal to consent
- Extracorporeal membrane oxygenation (ECMO) or ventricular assist device prior to surgery
- Therapeutic heparin use (unfractionated or low molecular weight) in the immediate preoperative period (<12 hr)
- Weight <3 kg
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 |
|---|---|---|
| Thrombin generation and Platelet Function TestingPoint-of-care testing of thrombin generation, platelet function, and rotational thromboelastometry | Device | – |
Primary outcome
Postoperative chest tube blood loss
Time frame: 24hr
9 secondary outcomes
Postoperative chest tube blood loss
Time frame: 6hr
Postoperative chest tube blood loss
Time frame: 12hr
Transfusion of blood products
Time frame: 24hr
All-cause mortality
Time frame: within 30 days
Length of hospital stay
Time frame: through study completion, an average of less than one month
Length of ICU stay
Time frame: within 30 days
Duration of mechanical ventilation
Time frame: within 30 days
Inotropes
Time frame: within 30 days
Kidney injury
Time frame: within 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2018.
- 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.
James D O'Leary, MBBCh, MM, MD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Platelet Function Tests and Thrombin Generation Tests, run by The Hospital for Sick Children at 1 site in Canada.
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 5 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 9 May 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James D O'Leary (416-813-7654 ext. 228845, james.oleary@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative chest tube blood loss (time frame: 24hr). 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 9 May 2018.