Antithrombin III Supplementation Prior to Cardiopulmonary Bypass for Neonates
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Measurements of safety will be same or less than placebo controls.
研究概览
简要总结
A prospective, randomized, placebo-controlled, double-blinded pilot study is planned. Neonates undergoing surgeries requiring cardiopulmonary bypass will receive antithrombin III (ATIII) supplementation or placebo in addition to standard anticoagulation with heparin as currently practiced at Children's Hospital of Wisconsin. We plan to enroll the first 60 sequential patients meeting criteria who consent to inclusion. The primary outcomes will be rates of adverse events to monitor safety. Secondary outcomes include volume of postoperative blood loss and packed red blood cell transfusion during the first 24 postoperative hours, and ATIII levels during and after bypass to determine pharmacokinetics.
详细描述
Hypothesis:
ATIII supplementation prior to initiation of cardiopulmonary bypass (CPB) to neonates will be safe and result in less postoperative bleeding and transfusion of packed red blood cells (pRBC) as compared to placebo controls.
Specific Aims:
- To determine the safety and feasibility of ATIII supplementation prior to initiation of CPB in neonates.
- To determine the pharmacokinetics of ATIII supplementation prior to initiation of CPB in neonates
- To compare the postoperative blood loss and pRBC transfusion requirements in an experimental group of neonates undergoing surgery requiring CPB who receive ATIII prior to initiation of CPB to that of a placebo control group that did not receive ATIII.
Inclusion Criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 4 Days 至 30 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all sequential neonates (4 - 30 days of age) undergoing surgery requiring cardiopulmonary bypass are eligible to be included in the study.
排除标准
- •prior operation utilizing cardiopulmonary bypass
- •weight less than 2 kilograms
- •prematurity less than 37 weeks estimated gestational age
- •previously diagnosed pro-thrombotic or hemorrhagic disorder
- •known intracranial hemorrhage
- •prior ATIII supplementation
- •prior therapeutic anticoagulant use
- •known hypersensitivity to goat and goat milk proteins.
研究组 & 干预措施
ATIII experimental group
30 neonates (4-30 days of age) undergoing surgery requiring cardiopulmonary bypass will receive Antithrombin (Recombinant) prior to initiation of bypass
干预措施: Antithrombin (Recombinant) (Drug)
Placebo Controls
30 neonates (4-30 days of age) undergoing surgery requiring cardiopulmonary bypass will receive placebo prior to initiation of bypass
干预措施: Placebo (Other)
结局指标
主要结局
Measurements of safety will be same or less than placebo controls.
时间窗: 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.
次要结局
- Postoperative blood loss(24 hours postoperatively)
- Postoperative pRBC transfusion volume(24 hours postoperatively)
- ATIII pharmacokinetics(24 hours postoperatively)
研究者
Robert Niebler
Assistant Professor
Medical College of Wisconsin