Point-of-care Assessment of Thrombin Generation and Platelet Function in Children Requiring Cardiopulmonary Bypass

• Sponsor: The Hospital for Sick Children (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02833025
• Collaborator: Synapse B.V. Research Institute, University of Maastricht (Other)
• Enrollment: 130
• Location: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 5.4

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Platelet Function Tests; Thrombin Generation Tests; Perioperative Coagulopathy	Device: Thrombin generation and Platelet Function Testing

Study Design

• Study Type: Observational
• Anticipated Enrollment: 130 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Point-of-care Assessment of Thrombin Generation and Platelet Function in Children Undergoing Cardiac Surgery With Cardiopulmonary Bypass
• Anticipated Study Start Date: Dec 1, 2018
• Anticipated Primary Completion Date: Dec 1, 2020
• Anticipated Study Completion Date: Dec 1, 2020

Outcome Measures

Primary Outcome Measures

1. Postoperative chest tube blood loss [24hr]

Secondary Outcome Measures

1. Postoperative chest tube blood loss [6hr]

2. Postoperative chest tube blood loss [12hr]

3. Transfusion of blood products [24hr]

4. All-cause mortality [within 30 days]

5. Length of hospital stay [through study completion, an average of less than one month]

6. Length of ICU stay [within 30 days]

7. Duration of mechanical ventilation [within 30 days]

8. Inotropes [within 30 days]

   Duration of inotropic support

9. Kidney injury [within 30 days]

   Acute kidney injury

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 5 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Age ≤5 years

2. Undergoing cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

1. Non-english speaking parents/care-givers

2. Refusal to consent

3. Extracorporeal membrane oxygenation (ECMO) or ventricular assist device prior to surgery

4. Therapeutic heparin use (unfractionated or low molecular weight) in the immediate preoperative period (<12 hr)

5. Weight <3 kg

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Hospital for Sick Children	Toronto	Ontario	Canada	M5G1X8

Sponsors and Collaborators

• The Hospital for Sick Children
• Synapse B.V. Research Institute, University of Maastricht

Investigators

• Principal Investigator: James D O'Leary, MBBCh, MM, MD, The Hospital for Sick Children

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: James O'Leary, Staff Anesthesiologist, The Hospital for Sick Children
• ClinicalTrials.gov Identifier: NCT02833025
• Other Study ID Numbers: 1000053849
• First Posted: Jul 14, 2016
• Last Update Posted: May 9, 2018
• Last Verified: May 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders; Thrombin

Study Results

No Results Posted as of May 9, 2018