The German Multicenter Pediatric Cardiac Surgery Group: Congenital Heart Adhesion Prevention (CHAP) Study
- Conditions
- Congenital heart defectsAdhesions
- Registration Number
- DRKS00029296
- Lead Sponsor
- Klinik für Kinderherzchirurgie und Chirurgie angeborener Herzfehler, Uniklinik RWTH Aachen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 135
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.
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
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method