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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03348072
First Posted: November 20, 2017
Last Update Posted: November 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pierre Wauthy, Brugmann University Hospital
  Purpose

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 Intervention
Cardiac Surgery Procedure: Cardiac surgery

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Comparative Study of Survival and Long-term Quality of Life After Cardiac Surgery in Patients Who Are Jehovah's Witnesses

Resource links provided by NLM:


Further study details as provided by Pierre Wauthy, Brugmann University Hospital:

Primary Outcome Measures:
  • 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 questionnaire

  • 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


Enrollment: 93
Actual Study Start Date: February 2016
Study Completion Date: March 2017
Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Jehovah's witnesses
Jehovah's witnesses having undergone cardiac surgery between 1991 till 2012. Blood perfusions refused.
Procedure: Cardiac surgery
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
Cardiac surgery

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Belgium
CHU Brugmann
Brussels, Belgium, 1020
Sponsors and Collaborators
Pierre Wauthy
Investigators
Principal Investigator: Pierre Wauthy, MD CHU Brugmann
  More Information

Responsible Party: Pierre Wauthy, Head of clinic, Brugmann University Hospital
ClinicalTrials.gov Identifier: NCT03348072     History of Changes
Other Study ID Numbers: CHUB-QoL Jehovah
First Submitted: November 16, 2017
First Posted: November 20, 2017
Last Update Posted: November 20, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No