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

Recruiting

• Conditions: Male; Female; Surgery,Cardiac
• Interventions: Procedure: Cardiac surgery

• Registration Number: NCT06175650
• Lead Sponsor: Jennifer Breel

Brief Summary

The aim of this study is to evaluate the differences between men and women undergoing cardiac surgery. We will look at perioperative factors such as body weight, body surface area, previous medical history, pharmacokinetics, transfusion, coagulation, cardiopulmonary bypass (CPB) related factors, cardiac function, inotropic requirements, risk, and outcome scores as well as morbidity and mortality at 30 and 90 days, 1, 5, and 10 years.

Detailed Description

Observational, multicentre, retrospective data collection from the mandatory Quality Assurance database (the Netherlands Heart Registry, (NHR), supplemented with data from the electronic patient files (EPIC). The retrospective data is already available.

In addition, we will continue the retrospective study into a prospective registry of data after the analysis of the retrospective data. Patients will be approached one, five and ten years after the operation and a questionnaire will be sent to document quality of life. No research-related interventions other than questionnaires will be performed

Study Timeline

• Study First Submitted: 2022-03-20
• Study Start: 2023-11-21
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-18
• Last Update Submitted: 2023-12-18
• Study First Posted: 2023-12-19
• Last Update Posted: 2023-12-19
• Primary Completion: 2025-11-21
• Study Completion: 2026-11-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5500

Inclusion Criteria

• Patients > 18 years
• All patients who underwent cardiac surgery from 1 January 2016 to the start of the study, in either of the centres (AMC or VUmc) (retrospective)
• All patients undergoing cardiac surgery from the start of the study (~March 2022) until approximately 2032

Exclusion Criteria

• Patients who object to the re-use of their care data or do not give consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Female	Cardiac surgery	Female patients undergoing cardiac surgery
Male	Cardiac surgery	Male patients undergoing cardiac surgery

Primary Outcome Measures

Name	Time	Method
Primary endpoint	up to 30 days post-surgery	Number of specific (coagulation), transfusion products,
Primary outcome	up to 30 days post-surgery or if still in hospital, until discharge	Times: surgical, cross-clamp, bypass, anesthetic, intensive care admission, hospital admission, etc.

Secondary Outcome Measures

Name	Time	Method
Health related Quality of life measured by PROMS	At 1, 5 and 10 years	Long term quality of life after cardiac surgery, measured by Seattle Angina Questionaire (SAQ), EuroQol Quality of life (EQ-5D-5L) and Coronary Revascularisation Outcome Questionnaire (CROQ) or other appropriate questionnaire
Morbidity and mortality	At 30, 90, 365 days	peroperative and post-operative complications
Survival	At 5 and 10 years	Long term survival

Trial Locations

Locations (1)

Academic Medical Center; 🇳🇱 Amsterdam, North Holland, Netherlands