Clinical Assessment of Thrombosis in Children After Heart Surgery

NCT01435473 | Completed DMC

• 1 other identifier: 1000020203
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Thrombosis

Keywords

pediatrics; thrombosis; thromboembolic complications; pediatric cardiac surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Baseline

• Genome-Wide Association Study (GWAS)

  Baseline

• Post-operative sign and symptoms of thrombosis

  Up to 10 days after surgery

• Post-thrombotic Syndrome (PTS) Evaluation

  Up to 2 years after surgery

• Neurodevelopment and functional health assessment

  Up to 2 years post- surgery

Study Arms (1)

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

Procedure: Cardiac Surgery

Interventions

Cardiac Surgery PROCEDURE

Children undergoing heart surgery

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children Undergoing Pediatric Heart Surgery at the Hospital for Sick Children who agree to participate in the CATCH research study.

You may qualify if:

• Pediatric patients scheduled for cardiac surgery requiring cardiopulmonary Bypass

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Thrombosis

Interventions

Cardiac Surgical Procedures

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• Brian W McCrindle, MD

  The Hospital for Sick Children, Toronto Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Cardiologist

Study Record Dates

• First Submitted: September 8, 2011
• First Posted: September 16, 2011
• Study Start: July 1, 2011
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2015
• Last Updated: February 1, 2016

Record last verified: 2016-01

Locations

CA (1)