Perioperative Coagulopathy, Platelet Function Tests, Thrombin Generation Tests
Conditions
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.
Interventions
DEVICEThrombin generation and Platelet Function Testing
Point-of-care testing of thrombin generation, platelet function, and rotational thromboelastometry
Sponsors
Synapse B.V. Research Institute, University of Maastricht
The Hospital for Sick Children
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 5 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative chest tube blood loss | 24hr |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Transfusion of blood products | 24hr | — |
| All-cause mortality | within 30 days | — |
| Length of hospital stay | through study completion, an average of less than one month | — |
| Postoperative chest tube blood loss | 6hr | — |
| Duration of mechanical ventilation | within 30 days | — |
| Inotropes | within 30 days | Duration of inotropic support |
| Kidney injury | within 30 days | Acute kidney injury |
| Length of ICU stay | within 30 days | — |
Countries
Canada
Contacts
Primary ContactJames D O'Leary
Outcome results
None listed