Actively Recruiting

Age: 18Years +
All Genders
ID06175650

Towards a Sex-specific Female Enhanced Recovery After Cardiac Surgery Pathway: An Observational Registration and Evaluation of Characteristics and Perioperative Management of Cardiac Surgery Patients

Led by Jennifer Breel · Updated on 2023-12-19

5500

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Brief Title

Towards a Sex-specific "Female Enhanced Recovery After Cardiac Surgery'' (F-ERAS) Pathway:

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients 18 years or older
  • Patients who underwent cardiac surgery from January 1, 2016, to the start of the study at participating centers
  • Patients undergoing cardiac surgery from the study start until approximately 2032
Not Eligible

You will not qualify if you...

  • Patients who object to the reuse of their care data or do not give consent

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

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

Surgery and Immediate Post-operative Care

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

Post-operative Follow-up

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

Long-term Monitoring

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

Trial Site Locations

Total: 1 location

1

Academic Medical Center

Amsterdam, North Holland, Netherlands, 1105 AZ

Actively Recruiting

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Research Team

J

Jennifer S Breel, MSc

S

Susanne Eberl, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Preoperative Care Practice for Female Cardiac Patients: A Survey From the Society of Cardiovascular Anesthesiologists.

Danop Nanegrungsunk, Shayna Patel, Thomas Jan...

https://pubmed.ncbi.nlm.nih.gov/34776353