NCT06175650

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

Towards a Sex-specific "Female Enhanced Recovery After Cardiac Surgery'' (F-ERAS) Pathway: An Observational Registration and Evaluation of Characteristics and Perioperative Management of Cardiac Surgery Patients

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 5,500 (estimated)
• Sponsor: Jennifer Breel · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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

Conditions

• Female
• Male
• Surgery,Cardiac

Interventions

Type	Name	Description
PROCEDURE	Cardiac surgery	Cardiac surgery of all types

Timeline

• Start date: 2023-11-21
• Primary completion: 2025-11-21
• Completion: 2026-11-21
• First posted: 2023-12-19
• Last updated: 2023-12-19

Locations

1 site across 1 country: Netherlands