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Comparative Study of Survival and Long-term Quality of Life After Cardiac Surgery in Patients Who Are Jehovah's Witnesses

Comparative Study of Survival and Long-term Quality of Life After Cardiac Surgery in Patients Who Are Jehovah's Witnesses

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03348072
Enrollment
93
Registered
2017-11-20
Start date
2016-02-29
Completion date
2017-03-31
Last updated
2017-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery

Brief summary

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.

Interventions

PROCEDURECardiac surgery

Cardiac surgery

Sponsors

Pierre Wauthy
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Quality of life (score)Evaluated once by means of a phone contact performed in 2016, irrespective of the date the surgery was performedScore 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.
Survival rateEvaluated once by means of a phone contact performed in 2016, irrespective of the date the surgery was performedSurvival rate

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026