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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
Sponsor:
Information provided by (Responsible Party):
Pierre Wauthy, Brugmann University Hospital

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.


Condition or disease Intervention/treatment
Cardiac Surgery Procedure: Cardiac surgery

Study Type : Observational
Actual Enrollment : 93 participants
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
Actual Study Start Date : February 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

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 Posted: November 20, 2017    Key Record Dates
Last Update Posted: November 22, 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