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

NCT03348072 | Completed

• 1 other identifier: CHUB-QoL Jehovah
• Study Type: observational
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Surgery

Outcome Measures

Primary Outcomes (2)

• 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

• Survival rate

  Survival rate

  Evaluated once by means of a phone contact performed in 2016, irrespective of the date the surgery was performed

Study Arms (2)

Jehovah's witnesses

Jehovah's witnesses having undergone cardiac surgery between 1991 till 2012. Blood perfusions refused.

Procedure: Cardiac surgery

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.

Procedure: Cardiac surgery

Interventions

Cardiac surgery PROCEDURE

Cardiac surgery

Control; Jehovah's witnesses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Jehovah's withnesses having undergone cardiac surgery between 1991 till 2012 (blood perfusions refused) and paired control group having had the same surgical interventions (blood perfusions allowed)

You may qualify if:

• Cardiac surgery with extra corporeal blood circulation
• Informed consent given

You may not qualify if:

• Dementia (must be able to answer the questionnaire)
• Control group: refusal of blood transfusions

Sponsors & Collaborators

• Pierre Wauthy: lead

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

Related Publications (1)

• Wauthy P, Pierrakos C, Chebli L, Tortora R. Long-term survival and quality of life in Jehovah's witnesses after cardiac surgery: a case control study. BMC Cardiovasc Disord. 2019 Mar 29;19(1):73. doi: 10.1186/s12872-019-1061-z.

  PMID: 30922241 DERIVED

MeSH Terms

Interventions

Cardiac Surgical Procedures

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• Pierre Wauthy, MD

  CHU Brugmann

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of clinic

Study Record Dates

• First Submitted: November 16, 2017
• First Posted: November 20, 2017
• Study Start: February 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: November 22, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)