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

Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03348072
• Other study ID #: CHUB-QoL Jehovah
• Status: Completed
• Phase: N/A
• First received: November 16, 2017
• Last updated: November 20, 2017
• Start date: February 2016
• Est. completion date: March 2017

Study information

• Verified date: November 2017
• Source: Brugmann University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

Procedure:
• Cardiac surgery
Cardiac surgery

Locations

Country	Name	City	State
Belgium	CHU Brugmann	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Pierre Wauthy

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life (score)	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.	Evaluated once by means of a phone contact performed in 2016, irrespective of the date the surgery was performed
Primary	Survival rate	Survival rate	Evaluated once by means of a phone contact performed in 2016, irrespective of the date the surgery was performed