Cardiac Surgery in Women in the Current Era: What Are the Gaps in Care?
Leslie Cho, Melina R Kibbe, Faisal Bakaeen...
https://pubmed.ncbi.nlm.nih.gov/34606298Actively Recruiting
Led by Jennifer Breel · Updated on 2023-12-19
5500
Participants Needed
1
Research Sites
52 weeks
Total Duration
This research aims to evaluate differences between men and women undergoing cardiac surgery by examining various perioperative factors. These include body weight, body surface area, medical history, pharmacokinetics, transfusion, coagulation, cardiopulmonary bypass-related factors, cardiac function, inotropic needs, risk and outcome scores, as well as morbidity and mortality at multiple time points up to 10 years. The study is observational and collects data retrospectively and prospectively to better understand sex-specific outcomes after cardiac surgery. The study collects retrospective data from the Netherlands Heart Registry and electronic patient files, covering patients who had cardiac surgery from January 2016 until the study's start. It then continues prospectively with patients undergoing cardiac surgery from the study start until around 2032. No experimental treatments are given; instead, data is gathered from standard care and supplemented with questionnaires sent to patients one, five, and ten years after surgery to assess quality of life. Participants will be followed through registry data and questionnaires to monitor outcomes such as morbidity, mortality, survival, and health-related quality of life at various intervals after surgery. The primary outcome focuses on events up to 30 days post-surgery, with longer-term follow-ups at 90 days, one year, five years, and ten years. No additional interventions are performed beyond routine care and questionnaires, allowing for comprehensive observation of patient experiences and outcomes over time.
CONDITIONS
Towards a Sex-specific "Female Enhanced Recovery After Cardiac Surgery'' (F-ERAS) Pathway:
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for consent and initial data collection
Duration - Up to 30 days or until hospital discharge
Participants undergo cardiac surgery and immediate post-operative care as part of routine healthcare.
Hospital stay and care visits as part of routine treatment
Duration - Up to 1 year
Participants are monitored for morbidity and mortality up to 365 days and quality of life through questionnaires.
Follow-up assessments including questionnaires at 1 year post-surgery
Duration - Up to 10 years
Participants are approached with questionnaires to document health-related quality of life and survival at 5 and 10 years after surgery.
Questionnaires sent at 5 and 10 years post-surgery
Total: 1 location
1
Academic Medical Center
Amsterdam, North Holland, Netherlands, 1105 AZ
Actively Recruiting
J
Jennifer S Breel, MSc
S
Susanne Eberl, PhD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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