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Patient population changed and no subjects eligible for the study.
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The purpose of this research is to understand if the medication called FEIBA helps to stop bleeding and decrease transfusion of blood products to small children operated on the heart.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FEIBA Group | Experimental | Pediatric patients ≤15 kg of weight, undergoing cardiac surgery with cardiopulmonary bypass will receive activated prothrombin complex concentrate (aPCC) FEIBA to be incorporated into standard treatment of post-bypass coagulopathic bleeding. |
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| Placebo Group | Placebo Comparator | Pediatric patients ≤15 kg of weight, undergoing cardiac surgery with cardiopulmonary bypass will receive a placebo to be incorporated into standard treatment of post-bypass coagulopathic bleeding. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FEIBA | Drug | Administered via the central line catheter after termination of cardiopulmonary bypass if bleeding related to poor clotting develops; in addition, according to conventional protocol blood products will be transfused simultaneously. Three small doses, 5 mg/kg each, will be available. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of units of allogeneic blood products required early perioperatively in pediatric cardiac patients. | Number of units of transfused allogeneic blood products after cardiopulmonary bypass in the operating room (OR) and in the intensive care unit (ICU) on postoperative day (POD) 0 and 1. | approximately 1 day postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital length of stay | Number of days admitted to the hospital | Through hospital discharge, approximately 3 days |
| Mortality | Total number of subject deaths |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elena Ashikhmina, MD, PhD | Mayo Clinic | Principal Investigator |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C065655 | anti-inhibitor coagulant complex |
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| Placebo | Drug | Contains no active ingredient and administered via the central line catheter after termination of cardiopulmonary bypass if bleeding related to poor clotting develops; in addition, according to conventional protocol blood products will be transfused simultaneously. |
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| Through hospital discharge, approximately 3 days |
| Intravascular and intracardiac thromboses | Number of subjects to experience intravascular and/or intracardiac thromboses up to POD 3 | approximately 3 days postoperatively |