Global Utilization And Registry Database for Improved heArt preservatioN
Last updated on July 2021Recruitment
- Recruitment Status
- Enrolling by invitation
- Estimated Enrollment
- 500
Summary
- Conditions
- Heart Defects, Congenital
- Heart Diseases
- Heart Failure
- Design
- Observational Model: CohortTime Perspective: Cross-Sectional
Participation Requirements
- Age
- Younger than 125 years
- Gender
- Both males and females
Description
This study is a registry study collecting data both retrospectively from patients already transplanted and prospectively from consecutively enrolled patients for heart transplantation. The study is a chart review study. Ongoing eligible recipients will undergo heart transplantation according to stan...
This study is a registry study collecting data both retrospectively from patients already transplanted and prospectively from consecutively enrolled patients for heart transplantation. The study is a chart review study. Ongoing eligible recipients will undergo heart transplantation according to standard practices at each participating institution. This study will be conducted at an estimated 25 institutions globally and will have about 500 patients. Subjects will be followed from transplant through one-year post-transplantation (i.e., 24 hours post-transplant, discharge, 30-days, and 1-year). GUARDIAN provides critical and contemporary data on patient outcomes, with additional insight into risk factors and patient-related indices. Both donor and recipient information along with procedural details (including transportation) will be collected to provide information for major discrete endpoints such as death, primary graft dysfunction, right ventricular dysfunction, CPB weaning and Inotrope use. Information about re-hospitalizations and re-transplantations is vital to address the integrated endpoint of days alive out of hospital, which is particularly relevant for this patient population. In addition, the number of in-hospital days and ICU time is closely tracked as the major resource utilized, after the initial transplant.
Tracking Information
- NCT #
- NCT04141605
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Andreas Zuckermann, MD ALLGEMEINES KRANKENHAUS WIEN