Antithrombin III Supplementation for Cardiopulmonary Bypass in Neonates
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|ClinicalTrials.gov Identifier: NCT01158729|
Recruitment Status : Terminated (Grant funding expired, poor patient enrollment)
First Posted : July 8, 2010
Last Update Posted : January 20, 2014
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Hemorrhage||Drug: Antithrombin (Recombinant) Other: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Antithrombin III Supplementation Prior to Cardiopulmonary Bypass for Neonates|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
Experimental: ATIII experimental group
30 neonates (4-30 days of age) undergoing surgery requiring cardiopulmonary bypass will receive Antithrombin (Recombinant) prior to initiation of bypass
Drug: Antithrombin (Recombinant)
Single dose of antithrombin (recombinant) to be given prior to initiation of cardiopulmonary bypass. Intravenous dose determined by following formula: ATIII dose given to patient = [(1.0 Units/mL - patient's measured ATIII concentration in Units/mL) X weight (kg) X 80 mL/kg] X (1 mL/175 Units)
Placebo Comparator: Placebo Controls
30 neonates (4-30 days of age) undergoing surgery requiring cardiopulmonary bypass will receive placebo prior to initiation of bypass
Single dose of placebo (0.9% NaCl) to be given prior to initiation of cardiopulmonary bypass. Intravenous dose determined by following formula: Placebo dose given to patient = [(1.0 Units/mL - patient's measured ATIII concentration in Units/mL) X weight (kg) X 80 mL/kg] X (1 mL/175 Units)
- Measurements of safety will be same or less than placebo controls. [ Time Frame: Hospital Discharge ]Mortality rate, incidence of ECMO support within 24 hours postoperatively, incidence of mediastinal exploration within 24 hours postoperatively, incidence of thrombotic disease at discharge (ultrasound or other radiographic evidence if obtained for routine patient care), incidence of intracranial hemorrhage (ultrasound or computed tomography if obtained for routine patient care), days to delayed sternal closure, days to cessation of mechanical ventilation, and days to hospital discharge in the experimental and control groups.
- Postoperative blood loss [ Time Frame: 24 hours postoperatively ]Blood loss will be volumes (mL/kg) of blood loss and chest tube output from 10 minutes after protamine administration to 24 hours after ICU admission. We will compare this data to placebo controls.
- Postoperative pRBC transfusion volume [ Time Frame: 24 hours postoperatively ]Transfusion will be volumes (mL/kg) of pRBC transfuion and 0.5 times volumes (mL/kg) of whole blood transfusion from 10 minutes after protamine administration to 24 hours after ICU admission. We will compare this data to placebo controls.
- ATIII pharmacokinetics [ Time Frame: 24 hours postoperatively ]ATIII levels drawn preoperatively, within 30 minutes after administration (prior to start of CPB), within 30 minutes of start of CPB, just prior to discontinuation of CPB, and upon admission to the ICU will be assessed to determine if the single dose of ATIII sustained normal ATIII levels in the experimental group throughout these time periods.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01158729
|United States, Wisconsin|
|Children's Hospital of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Principal Investigator:||Robert A Niebler, M.D.||Medical College of Wisconsin|