Congenital Heart DiseaseNCT02064179
Assessment of the Efficacy of the First Aspirin Dose in Children Undergoing Surgery for Congenital Heart Disease (CHD) Who Require Post-operative Antiplatelet Therapy
An observational study of Congenital Heart Disease, run by University of Colorado, Denver.
Trial summary
The use of heparin and aspirin for their respective anticoagulation and antiplatelet effects is routine in intensive care units around the country and world in children who have undergone surgery for congenital heart disease (CHD) who are at risk for thrombosis after repair. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Congenital Heart Disease
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Jun 2015
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study population includes children aged 0-18 with congenital heart disease (CHD) in the immediate post- operative period who receive heparin infusion prior to initiation of long-term antiplatelet therapy. The current study population includes patients who have undergone one of these surgeries requiring aspirin therapy. The following are the surgical procedures included in this study: 1. Arterio-venous shunts: classic and modified Blalock-Taussig (BT) shunts, and central shunts. 2. Veno-venous shunts: partial cavo-pulmonary connections (Glenn anastomosis), total cavo-pulmonary shunts (Fontan), and right ventricle to pulmonary artery conduits. 3. Patients requiring coronary artery re-implantation: arterial switch operation for transposition of the great arteries and repair of anomalous left coronary artery arising from the pulmonary artery. 4. Pulmonary valve replacement.
Who may be able to join
- Age 0-18
- Undergoing surgery for congenital heart disease requiring oral antiplatelet therapy
Who cannot join
- Strict: personal or family history of bleeding/clotting disorder, patients requiring anticoagulation rather than antiplatelet therapy after surgery.
- Relative: patients with significant post-operative bleeding precluding the use of anticoagulation and/or antiplatelet therapy within the first 48-72 hours (eg. clinical instability preventing the initiation of oral aspirin therapy), patients requiring additional fresh platelet transfusion after the initiation of post-operative heparin infusion.
About this study
Official title: Assessment of Efficacy of the First Aspirin Dose in Children Undergoing Surgery for Congenital Heart Disease (CHD) Who Require Post-operative Antiplatelet Therapy; Evaluated by Thromboelastograph (TEG) Analysis and TEG-platelet Mapping
The use of heparin and aspirin for their respective anticoagulation and antiplatelet effects is routine in intensive care units around the country and world in children who have undergone surgery for congenital heart disease (CHD) who are at risk for thrombosis after repair. Most common protocols recommend heparin infusions after surgery with transition to oral aspirin when oral intake begins. Patients at risk for thrombosis after congenital heart surgery requiring long-term antiplatelet therapy include those undergoing shunt placement for single-ventricle palliation or establishment of pulmonary blood flow, valve replacements, or coronary artery manipulation. Post-operative thrombosis after congenital heart surgery is rare, but thrombosis can result in death. The routine use of aspirin in these patients is intended to prevent the potentially catastrophic consequences of thrombosis. However, there is no routine clinical assessment of the platelet inhibitory effect of aspirin; nor have there been any prospective studies to assess the effectiveness of aspirin's antiplatelet effect in children after congenital heart surgery. No data exists to suggest that the first dose of aspirin transition from heparin infusion is either sufficient or insufficient in its antiplatelet effect.
In this study, the investigators will evaluate the effectiveness of the first aspirin dose in its antiplatelet effects after surgery for congenital heart disease. Degree of antiplatelet effect will be evaluated with thromboelastograph (TEG) and TEG-platelet mapping study analysis. Thromboelastography is a clinical laboratory method of assessing whole blood hemostasis and allows for assessment of clot formation, strength, and stability. TEG is most commonly used in patients at risk for bleeding or thrombosis and also to monitor antiplatelet therapies (such as aspirin).
The investigators hypothesize: the first dose of aspirin transitioned from heparin infusion after congenital heart surgery is sufficient in its antiplatelet effect as tested by TEG and TEG-platelet mapping studies. Confirmation of the antiplatelet effect of aspirin will help support the current practice of empiric aspirin therapy to prevent post-operative thrombosis in children after congenital heart surgery.
- Conditions
- Congenital Heart Disease
- Keywords
- Congenital heart disease, Antiplatelet therapy, Aspirin
- Medical subject headings
- Heart Defects, Congenital
What is being measured
The primary outcome is the main question the study is designed to answer.
Full platelet inhibition with aspirin 4-hours after surgery compared to prior to surgery
We will obtain thromboelastograph and thromboelastograph-platelet mapping studies at 4 time points: (1) prior to surgery and cardiopulmonary bypass, (2) 24-hours prior to the first aspirin dose, (3) 4-hours after the first aspirin dose, (4) 24-hours after the first aspirin dose (prior to the second).
Primary Outcome measure will compare the first-postoperative TEG/TEG-platelet mapping results (4-hours after surgery) to the pre-operative TEG/TEG-platelet mapping results (prior to surgery)
Measured: 4-hours after first aspirin dose
Secondary outcomes (1)
Full platelet inhibition at 24-hours if not achieved by 4-hours after aspirin administration
We will obtain thromboelastograph and thromboelastograph-platelet mapping studies at 4 time points: (1) prior to surgery and cardiopulmonary bypass, (2) 24-hours prior to the first aspirin dose, (3) 4-hours after the first aspirin dose, (4) 24-hours after the first aspirin dose (prior to the second).
Secondary outcome will compare 24-hour TEG/TEG-platelet mapping to 4-hour TEG/TEG-platelet mapping after surgery
Measured: 24-hours after first aspirin dose (prior to second)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study startApr 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02064179
- Sponsor's protocol ID
- 13-3167
- Other IDs
- UL1TR001082
- Status last verified
- Jul 2019
- First submitted
- 11 Feb 2014
- Last updated
- 11 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Efficacy of the First Aspirin Dose in Children Undergoing Surgery for Congenital Heart Disease (CHD) Who Require Post-operative Antiplatelet Therapy; Evaluated by Thromboelastograph (TEG) Analysis and TEG-platelet Mapping
- ClinicalTrials.gov ID
- NCT02064179
- Acronym / sponsor ID
- 13-3167
- Conditions
- Congenital Heart Disease
- Keywords
- Congenital heart disease, Antiplatelet therapy, Aspirin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 17 Feb 2014 (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.
The use of heparin and aspirin for their respective anticoagulation and antiplatelet effects is routine in intensive care units around the country and world in children who have undergone surgery for congenital heart disease (CHD) who are at risk for thrombosis after repair. Most common protocols recommend heparin infusions after surgery with transition to oral aspirin when oral intake begins. Patients at risk for thrombosis after congenital heart surgery requiring long-term antiplatelet therapy include those undergoing shunt placement for single-ventricle palliation or establishment of pulmonary blood flow, valve replacements, or coronary artery manipulation. Post-operative thrombosis after congenital heart surgery is rare, but thrombosis can result in death. The routine use of aspirin in these patients is intended to prevent the potentially catastrophic consequences of thrombosis. However, there is no routine clinical assessment of the platelet inhibitory effect of aspirin; nor have there been any prospective studies to assess the effectiveness of aspirin's antiplatelet effect in children after congenital heart surgery. No data exists to suggest that the first dose of aspirin transition from heparin infusion is either sufficient or insufficient in its antiplatelet effect.
In this study, the investigators will evaluate the effectiveness of the first aspirin dose in its antiplatelet effects after surgery for congenital heart disease. Degree of antiplatelet effect will be evaluated with thromboelastograph (TEG) and TEG-platelet mapping study analysis. Thromboelastography is a clinical laboratory method of assessing whole blood hemostasis and allows for assessment of clot formation, strength, and stability. TEG is most commonly used in patients at risk for bleeding or thrombosis and also to monitor antiplatelet therapies (such as aspirin).
The investigators hypothesize: the first dose of aspirin transitioned from heparin infusion after congenital heart surgery is sufficient in its antiplatelet effect as tested by TEG and TEG-platelet mapping studies. Confirmation of the antiplatelet effect of aspirin will help support the current practice of empiric aspirin therapy to prevent post-operative thrombosis in children after congenital heart surgery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study population includes children aged 0-18 with congenital heart disease (CHD) in the immediate post- operative period who receive heparin infusion prior to initiation of long-term antiplatelet therapy. The current study population includes patients who have undergone one of these surgeries requiring aspirin therapy. The following are the surgical procedures included in this study: 1. Arterio-venous shunts: classic and modified Blalock-Taussig (BT) shunts, and central shunts. 2. Veno-venous shunts: partial cavo-pulmonary connections (Glenn anastomosis), total cavo-pulmonary shunts (Fontan), and right ventricle to pulmonary artery conduits. 3. Patients requiring coronary artery re-implantation: arterial switch operation for transposition of the great arteries and repair of anomalous left coronary artery arising from the pulmonary artery. 4. Pulmonary valve replacement.
Key inclusion criteria (2 listed)
- Age 0-18
- Undergoing surgery for congenital heart disease requiring oral antiplatelet therapy
Key exclusion criteria (2 listed)
- Strict: personal or family history of bleeding/clotting disorder, patients requiring anticoagulation rather than antiplatelet therapy after surgery.
- Relative: patients with significant post-operative bleeding precluding the use of anticoagulation and/or antiplatelet therapy within the first 48-72 hours (eg. clinical instability preventing the initiation of oral aspirin therapy), patients requiring additional fresh platelet transfusion after the initiation of post-operative heparin infusion.
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
Full platelet inhibition with aspirin 4-hours after surgery compared to prior to surgery
Time frame: 4-hours after first aspirin dose
We will obtain thromboelastograph and thromboelastograph-platelet mapping studies at 4 time points: (1) prior to surgery and cardiopulmonary bypass, (2) 24-hours prior to the first aspirin dose, (3) 4-hours after the first aspirin dose, (4) 24-hours after the first aspirin dose (prior to the second). Primary Outcome measure will compare the first-postoperative TEG/TEG-platelet mapping results (4-hours after surgery) to the pre-operative TEG/TEG-platelet mapping results (prior to surgery)
1 secondary outcome
Full platelet inhibition at 24-hours if not achieved by 4-hours after aspirin administration
Time frame: 24-hours after first aspirin dose (prior to second)
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 11 Jul 2019.
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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 Congenital Heart Disease, run by University of Colorado, Denver.
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: finished, as of the sponsor's last update on 11 Jul 2019. 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?
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?
Full platelet inhibition with aspirin 4-hours after surgery compared to prior to surgery (time frame: 4-hours after first aspirin dose). 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 11 Jul 2019.