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Phase III Study Comparing Two Methods of Cardioplegia in Aortic Valve Surgery Custodiol-N Versus Custodiol

NCT02098772 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 530

Last updated 2020-01-18

No results posted yet for this study

Summary

The objective of this investigation is to compare the cardioprotective effects and safety of two cardioplegic solutions, HTK Cardioplegic Solution (Custodiol) and Custodiol-N in patients undergoing aortic valve surgery. The study design is a prospective, double blind, multicenter, randomized, Phase III comparison study intended to demonstrate superiority in surgical outcome between Custodiol and Custodiol-N as determined by CK-MB peak value 4-24 hours after opening of the aortic cross-clamp (primary endpoint), catecholamine requirement (cumulative dose) and cardiac Troponin T, occurrence of comorbid events postoperatively (e.g., myocardial infarction).

Conditions

  • Aortic Valve Disease
  • Coronary Artery Disease (CAD)

Interventions

DRUG

Custodiol-N

comparison of two cardioplegic solutions, Custodiol-N versus Custodiol, in aortic valve surgery

DRUG

Custodiol

comparison of two cardioplegic solutions, Custodiol-N versus Custodiol, in aortic valve surgery

Sponsors & Collaborators

  • Dr. F. Köhler Chemie GmbH

    lead INDUSTRY

Principal Investigators

  • Gabor Szabó, Prof. · Department of Cardiac Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
30 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2018-11-16
Completion
2018-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02098772 on ClinicalTrials.gov