Comparative Study of Survival and Long-term Quality of Life After Cardiac Surgery in Patients Who Are Jehovah's Witnesses
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|ClinicalTrials.gov Identifier: NCT03348072|
Recruitment Status : Completed
First Posted : November 20, 2017
Last Update Posted : November 22, 2017
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.
|Condition or disease||Intervention/treatment|
|Cardiac Surgery||Procedure: Cardiac surgery|
|Study Type :||Observational|
|Actual Enrollment :||93 participants|
|Official Title:||Comparative Study of Survival and Long-term Quality of Life After Cardiac Surgery in Patients Who Are Jehovah's Witnesses|
|Actual Study Start Date :||February 2016|
|Actual Primary Completion Date :||March 2017|
|Actual Study Completion Date :||March 2017|
Jehovah's witnesses having undergone cardiac surgery between 1991 till 2012. Blood perfusions refused.
Procedure: Cardiac surgery
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.
Procedure: Cardiac surgery
- 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 ]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.
- Survival rate [ Time Frame: Evaluated once by means of a phone contact performed in 2016, irrespective of the date the surgery was performed ]Survival rate
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03348072
|Brussels, Belgium, 1020|
|Principal Investigator:||Pierre Wauthy, MD||CHU Brugmann|