- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03348072
Comparative Study of Survival and Long-term Quality of Life After Cardiac Surgery in Patients Who Are Jehovah's Witnesses
This is a comparative study on the survival and long-term quality of life of Jehovah's witnesses having undergone a cardiac surgery and having refused blood transfusions for religious reasons. This group will be compared with two other groups having no restrictions on this subject.
The purpose of the study is to evaluate the impact of this decision on survival and postoperative quality of life, in the long term.
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Brussels, Belgium, 1020
- CHU Brugmann
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Cardiac surgery with extra corporeal blood circulation
- Informed consent given
Exclusion Criteria:
- Dementia (must be able to answer the questionnaire)
- Control group: refusal of blood transfusions
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Jehovah's witnesses
Jehovah's witnesses having undergone cardiac surgery between 1991 till 2012.
Blood perfusions refused.
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Cardiac surgery
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Control
Paired control group, twice as big as the experimental group.
Pairing criteria: age, sex, type of surgery performed.
The control group must accept blood transfusions.
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Cardiac surgery
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life (score)
Time Frame: Evaluated once by means of a phone contact performed in 2016, irrespective of the date the surgery was performed
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Score computed with the "MacNew Heart Disease health-related quality of life instrument".The MacNew is a valuable tool for assessing and evaluating health related quality of life in heart disease patients.
It consists of 27 questions, falling into 3 possible domains: physicial limitation capacity (13 questions), emotional domain (14 questions), social domain (13 questions), symptom related (5 questions).
The time frame for the MacNew is the previous two weeks.
Scoring of the MacNew is simple: one score in each domain and a global score (4 scores).
The maximum possible score in any domain is 7 [high HRQL] and the minimum is 1 [poor HRQL].The global score is calculated as the average over all scored items unless one of the domains is completely missing.
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Evaluated once by means of a phone contact performed in 2016, irrespective of the date the surgery was performed
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Survival rate
Time Frame: Evaluated once by means of a phone contact performed in 2016, irrespective of the date the surgery was performed
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Survival rate
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Evaluated once by means of a phone contact performed in 2016, irrespective of the date the surgery was performed
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pierre Wauthy, MD, CHU Brugmann
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CHUB-QoL Jehovah
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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