DRKS00029296招募中不适用
The German Multicenter Pediatric Cardiac Surgery Group: Congenital Heart Adhesion Prevention (CHAP) Study - CHAP
Klinik für Kinderherzchirurgie und Chirurgie angeborener Herzfehler, Uniklinik RWTH Aachen0 个研究点目标入组 135 人开始时间: 2022年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 135
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 38 Pregnancy 至 30 Days（—）
- 性别
- All
入选标准
- •1. Newborns (within 30 days of birth) with ductal-dependent pulmonary or systemic circulation who receive a systemic-to-pulmonary shunt via sternotomy. Shunt procedure (OP1) can be performed with or without CPB and include: Blalock-Taussig shunt, central aorto-pulmonary shunt and xano-shunt (right ventricular to pulmonary artery shunt).
- •2. The patient’s legal representative(s) approve(s) the patient’s participation in the study by signing the informed consent.
- •3. Anticipation that the second sternotomy procedure (OP2: bidirectional Glenn, corrective surgery or shunt-exchange) will be performed at an age of the patient beyond 3 months and within the first year of life.
- •4. Anticipation that both OP1 and OP2 are performed in a study center.
排除标准
- •1. Previous sternotomy
- •2. Birth weight < 2.5 kg
- •3. Gestational age < 38 weeks
- •4. Obstructed pulmonary venous return (pulmonary congestion)
- •5. Shock (mechanical circulatory support and/or lactate > 5 mmol/l within 48 hours before surgery)
- •6. Infection (CRP > 20 mg/l within 48 hours before surgery)
- •7. Kidney failure (serum creatinine > 1.5 mg/dl or urine output < 0.5 ml/kg/h within 48 hours before surgery)
- •8. Known intolerance to starchy or polyethylene glycol - containing substances
- •9. The patient is participating in another device or drug study
研究者
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