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Clinical Trials/DRKS00029296
DRKS00029296
Recruiting
Not Applicable

The German Multicenter Pediatric Cardiac Surgery Group: Congenital Heart Adhesion Prevention (CHAP) Study - CHAP

Klinik für Kinderherzchirurgie und Chirurgie angeborener Herzfehler, Uniklinik RWTH Aachen0 sites135 target enrollmentAugust 1, 2022
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ConditionsCongenital heart defectsAdhesions

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Congenital heart defectsAdhesions
Sponsor
Klinik für Kinderherzchirurgie und Chirurgie angeborener Herzfehler, Uniklinik RWTH Aachen
Enrollment
135
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 1, 2022
End Date
TBD
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Klinik für Kinderherzchirurgie und Chirurgie angeborener Herzfehler, Uniklinik RWTH Aachen

Eligibility Criteria

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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

Outcomes

Primary Outcomes

Not specified

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