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| Name | Class |
|---|---|
| Synapse B.V. Research Institute, University of Maastricht | UNKNOWN |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thrombin generation and Platelet Function Testing | Device | Point-of-care testing of thrombin generation, platelet function, and rotational thromboelastometry |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative chest tube blood loss | 24hr |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative chest tube blood loss | 6hr | |
| Postoperative chest tube blood loss | 12hr | |
| Transfusion of blood products |
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Inclusion Criteria:
Exclusion Criteria:
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Children aged ≤5 years undergoing cardiac surgery with cardiopulmonary bypass
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| James D O'Leary | Contact | 416-813-7654 | 228845 | james.oleary@sickkids.ca |
| Name | Affiliation | Role |
|---|---|---|
| James D O'Leary, MBBCh, MM, MD | The Hospital for Sick Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital for Sick Children | Toronto | Ontario | M5G1X8 | Canada |
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Whole blood
| 24hr |
| All-cause mortality | within 30 days |
| Length of hospital stay | through study completion, an average of less than one month |
| Length of ICU stay | within 30 days |
| Duration of mechanical ventilation | within 30 days |
| Inotropes | Duration of inotropic support | within 30 days |
| Kidney injury | Acute kidney injury | within 30 days |