ThrombosisCATCHNCT01435473
Clinical Assessment of Thrombosis in Children After Heart Surgery
An observational study of Thrombosis, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
Thromboembolic complications (TCs) are important causes of morbidity and mortality after pediatric cardiac surgery, resulting in longer hospital stay, increased risk of early and late post-surgical complications, early reoperation, neurologic and organ damage, and potentially death. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Thrombosis
- What is being tested?
- Cardiac Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2011to Dec 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: Children Undergoing Pediatric Heart Surgery at the Hospital for Sick Children who agree to participate in the CATCH research study.
Who may be able to join
- Pediatric patients scheduled for cardiac surgery requiring cardiopulmonary Bypass
Who cannot join
- Known severe risk factors to thromboembolic complications
- Active cancer
- Congenital coagulopathy (e.g. haemophilia)
- No planned cardiology follow-up at the Hospital for Sick Children
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Assessment of Thrombosis in Children After Heart Surgery: The CATCH Study
Thromboembolic complications (TCs) are important causes of morbidity and mortality after pediatric cardiac surgery, resulting in longer hospital stay, increased risk of early and late post-surgical complications, early reoperation, neurologic and organ damage, and potentially death. The true incidence of blood clots in pediatric surgical patients is unknown.
The overarching objective of this study is to further our understanding of TCs, including quantification, characterization and risk stratification. This study will ultimately allow the development of effective tools for prevention and early identification of TCs, rather than focusing on treatment alone.
Read the detailed description
There is very limited data on TCs associated with cardiac surgery in pediatric patients. The actual incidence of TCs in this context is not currently known reflecting a lack of clinical suspicion, reporting biases, and/or the use of inappropriate diagnostic tests
Pediatric cardiac surgery is associated with disruption of blood flow, platelet dysfunction and activation, and blood hypercoagulability; all of which are contributing to clot formation
All congenital heart defects are associated with blood flow disturbance but some are associated with more extreme disturbances. The investigators hypothesize that not all types of CHD repairs will be at the same risk of TCs based on the extent of blood flow disturbances they cause. The investigators hypothesize that line location, difficulties in line insertion, including multiple insertion attempts and longer duration of indwelling will be associated with increased risk of TCs.
Pediatric cardiac surgery is associated with inflammation and platelet activation, both of which are potent contributors to blood hypercoagulability: CPB presents a hemostatic challenge associated with an abundance of pro-thrombotic risk factors and an opposite presence of pro-hemorrhagic risk factors. The investigators hypothesize that factors associated with increased platelet activation and inflammation, and in consequence, greater laboratory values of markers of platelet activation and inflammation, will be associated with increased risk of TCs.
Coagulation system activity in children is immature, hyporeactive and exhibits a high degree of resistance to heparin and anticoagulation. The investigators theorize that lower levels of coagulation system activity, presence of high-risk genetic polymorphisms, greater CPB hemodilution, increased heparin requirement and lower blood heparin activity expressed by anti-factor X activity (anti-Xa) concentration during CPB and greater requirement for allogeneic blood will be associated for increased risk of TCs.
There is a lack of consensus on clinical and laboratory signs/symptoms of active thrombosis and on which patients should be routinely screened for TCs. One of the most difficult aspects in the management of TCs is the fact that many episodes are asymptomatic or have non-specific symptoms. Creating a risk stratification model including both clinical and laboratory abnormalities which could be indicative of TCs in the post-operative period in order to identify patients who should undergo more targeted screening is the third aim of this study.
Many methods of TC management have limited effectiveness while highly effective methods are often associated with much risk. The use of thrombolytics in children is rare and only partially effective in many cases. The margin of safety for treatment is thought to be very narrow; the reported frequency of major bleeding episodes varies from 5% to 40%.
Outcomes of TCs are suboptimal, early surgical and long-term complications for survivors are frequent. The creation of risk stratification models for suboptimal surgical outcomes, PTS syndrome and, lower functional health status after surgery will be the fourth and final aim of this study.
- Conditions
- Thrombosis
- Being tested
- Cardiac Surgery
- Keywords
- pediatrics, thrombosis, thromboembolic complications, pediatric cardiac surgery
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac SurgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Children undergoing heart surgery | The study will follow children undergoing cardiac surgery at The Hospital for Sick Children from pre-consultation, throughout surgery, recovery and post-operative follow-up Receives: Procedure: Cardiac Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Thromboembolic Complications (TC) after pediatric cardiac surgery
Thrombosis will be recorded through review of post-operative clinical assessments, targeted laboratory testing for blood abnormalities and echocardiographic/ultrasound evaluation.
Measured: Outcome will be recorded throughout the duration of the participants hospital stay, an expected average of 10 days
Secondary outcomes (7)
Assessment of the patients' coagulation, hemostatic and inflammatory system activity
Standard coagulation panel to assess the function of the coagulation system in order to identify the degree of maturity, potential for resistance to anticoagulation and overall activity of the coagulation system.
Measured: Baseline
Genome-Wide Association Study (GWAS)
To identify genetic polymorphisms associated with coagulation system activity, sensitivity and overall thrombotic risk.
Measured: Baseline
Post-operative sign and symptoms of thrombosis
Daily clinical assessment of signs and symptoms of thrombosis
Measured: Up to 10 days after surgery
Post-thrombotic Syndrome (PTS) Evaluation
Assessment of upper and lower limbs based on the adaptation of the Khule scale. PTS will be classified as mild, moderate and severe.
Measured: Up to 2 years after surgery
Neurodevelopment and functional health assessment
Subject will undergo Ages and Stages (ASQ, Child Health Questionnaires and PedsQL)
Measured: Up to 2 years post- surgery
Response of the patients coagulation, hemostatic and inflammatory system activity to cardiopulmonary bypass
Repeat of complete blood count, inflammatory markers, coagulation and fibrolnolytic systems activity
Measured: Up to 10 days after surgery
Proportion of patients with thrombo-occlusive complications of thrombosis
Following events associated with thrombosis:
- Death / cardiorespiratory arrest associated with thrombosis
- Embolism (cardioembolic stroke, pulmonary embolism)
- Obstruction (sinovenous stroke, SVC syndrome)
- Unanticipated procedures directed at thrombosis or its clinical impact
- Escalation of antithrombotic treatment
Measured: 18-24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2011 (estimated)
- Study startJul 2011
- Primary completionNov 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombosisStudies 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
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian McCrindle, The Hospital for Sick Children
- Investigators
- Brian W McCrindle, MD, Principal investigator, The Hospital for Sick Children, Toronto Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01435473
- Sponsor's protocol ID
- 1000020203
- Acronym
- CATCH
- Status last verified
- Jan 2016
- First submitted
- 8 Sep 2011
- Last updated
- 1 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of Thrombosis in Children After Heart Surgery: The CATCH Study
- ClinicalTrials.gov ID
- NCT01435473
- Acronym / sponsor ID
- CATCH / 1000020203
- Conditions
- Thrombosis
- Keywords
- pediatrics, thrombosis, thromboembolic complications, pediatric cardiac surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 16 Sep 2011 (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.
Thromboembolic complications (TCs) are important causes of morbidity and mortality after pediatric cardiac surgery, resulting in longer hospital stay, increased risk of early and late post-surgical complications, early reoperation, neurologic and organ damage, and potentially death. The true incidence of blood clots in pediatric surgical patients is unknown.
The overarching objective of this study is to further our understanding of TCs, including quantification, characterization and risk stratification. This study will ultimately allow the development of effective tools for prevention and early identification of TCs, rather than focusing on treatment alone.
Detailed description
There is very limited data on TCs associated with cardiac surgery in pediatric patients. The actual incidence of TCs in this context is not currently known reflecting a lack of clinical suspicion, reporting biases, and/or the use of inappropriate diagnostic tests
Pediatric cardiac surgery is associated with disruption of blood flow, platelet dysfunction and activation, and blood hypercoagulability; all of which are contributing to clot formation
All congenital heart defects are associated with blood flow disturbance but some are associated with more extreme disturbances. The investigators hypothesize that not all types of CHD repairs will be at the same risk of TCs based on the extent of blood flow disturbances they cause. The investigators hypothesize that line location, difficulties in line insertion, including multiple insertion attempts and longer duration of indwelling will be associated with increased risk of TCs.
Pediatric cardiac surgery is associated with inflammation and platelet activation, both of which are potent contributors to blood hypercoagulability: CPB presents a hemostatic challenge associated with an abundance of pro-thrombotic risk factors and an opposite presence of pro-hemorrhagic risk factors. The investigators hypothesize that factors associated with increased platelet activation and inflammation, and in consequence, greater laboratory values of markers of platelet activation and inflammation, will be associated with increased risk of TCs.
Coagulation system activity in children is immature, hyporeactive and exhibits a high degree of resistance to heparin and anticoagulation. The investigators theorize that lower levels of coagulation system activity, presence of high-risk genetic polymorphisms, greater CPB hemodilution, increased heparin requirement and lower blood heparin activity expressed by anti-factor X activity (anti-Xa) concentration during CPB and greater requirement for allogeneic blood will be associated for increased risk of TCs.
There is a lack of consensus on clinical and laboratory signs/symptoms of active thrombosis and on which patients should be routinely screened for TCs. One of the most difficult aspects in the management of TCs is the fact that many episodes are asymptomatic or have non-specific symptoms. Creating a risk stratification model including both clinical and laboratory abnormalities which could be indicative of TCs in the post-operative period in order to identify patients who should undergo more targeted screening is the third aim of this study.
Many methods of TC management have limited effectiveness while highly effective methods are often associated with much risk. The use of thrombolytics in children is rare and only partially effective in many cases. The margin of safety for treatment is thought to be very narrow; the reported frequency of major bleeding episodes varies from 5% to 40%.
Outcomes of TCs are suboptimal, early surgical and long-term complications for survivors are frequent. The creation of risk stratification models for suboptimal surgical outcomes, PTS syndrome and, lower functional health status after surgery will be the fourth and final aim of this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children undergoing heart surgery | – | Procedure: Cardiac SurgeryThe study will follow children undergoing cardiac surgery at The Hospital for Sick Children from pre-consultation, throughout surgery, recovery and post-operative follow-up |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children Undergoing Pediatric Heart Surgery at the Hospital for Sick Children who agree to participate in the CATCH research study.
Key inclusion criteria (1 listed)
- Pediatric patients scheduled for cardiac surgery requiring cardiopulmonary Bypass
Key exclusion criteria (4 listed)
- Known severe risk factors to thromboembolic complications
- Active cancer
- Congenital coagulopathy (e.g. haemophilia)
- No planned cardiology follow-up at the Hospital for Sick Children
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 |
|---|---|---|
| Cardiac Surgery | Procedure or surgery | Children undergoing heart surgery |
Primary outcome
Incidence of Thromboembolic Complications (TC) after pediatric cardiac surgery
Time frame: Outcome will be recorded throughout the duration of the participants hospital stay, an expected average of 10 days
Thrombosis will be recorded through review of post-operative clinical assessments, targeted laboratory testing for blood abnormalities and echocardiographic/ultrasound evaluation.
7 secondary outcomes
Assessment of the patients' coagulation, hemostatic and inflammatory system activity
Time frame: Baseline
Genome-Wide Association Study (GWAS)
Time frame: Baseline
Post-operative sign and symptoms of thrombosis
Time frame: Up to 10 days after surgery
Post-thrombotic Syndrome (PTS) Evaluation
Time frame: Up to 2 years after surgery
Neurodevelopment and functional health assessment
Time frame: Up to 2 years post- surgery
Response of the patients coagulation, hemostatic and inflammatory system activity to cardiopulmonary bypass
Time frame: Up to 10 days after surgery
Proportion of patients with thrombo-occlusive complications of thrombosis
Time frame: 18-24 months after surgery
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 1 Feb 2016.
Related trials for Thrombosis
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
RecruitingObservational study
Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System
Pulmonary Embolism
RecruitingPhase 2
SBRT With Immunotherapy and Atezo-Bev in HCC With Major Portal Vein Thrombosis
HCC
Not yet recruiting
Pilot Study Evaluating Catheter Directed Thrombolysis Device in Acute Intermediate Risk Pulmonary Embolism
Pulmonary Embolism (PE), Pulmonary Embolism With Right Ventricle Enlargement
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
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.
Brian W McCrindle, MD principal investigator
The Hospital for Sick Children, Toronto Canada
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 Thrombosis, 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 1 inclusion and 4 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 1 Feb 2016. 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?
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?
Incidence of Thromboembolic Complications (TC) after pediatric cardiac surgery (time frame: Outcome will be recorded throughout the duration of the participants hospital stay, an expected average of 10 days). 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 1 Feb 2016.