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

Female Clinical Trial

— F-ERAS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06175650
• Other study ID #: W22_051 # 22.082
• Status: Recruiting
• Start date: November 21, 2023
• Est. completion date: November 21, 2026

Study information

• Verified date: December 2023
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Jennifer S Breel, MSc
• Phone: +31610019257
• Email: j.s.breel[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5500
• Est. completion date: November 21, 2026
• Est. primary completion date: November 21, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Female
• Male

Intervention

Procedure:
• Cardiac surgery
Cardiac surgery of all types

Locations

Country	Name	City	State
Netherlands	Academic Medical Center	Amsterdam	North Holland

Sponsors (1)

Lead Sponsor	Collaborator
Jennifer Breel

Country where clinical trial is conducted

Netherlands, 

References & Publications (4)

Cho L, Kibbe MR, Bakaeen F, Aggarwal NR, Davis MB, Karmalou T, Lawton JS, Ouzounian M, Preventza O, Russo AM, Shroyer AW, Zwischenberger BA, Lindley KJ. Cardiac Surgery in Women in the Current Era: What Are the Gaps in Care? Circulation. 2021 Oct 5;144(14):1172-1185. doi: 10.1161/CIRCULATIONAHA.121.056025. Epub 2021 Oct 4. — View Citation

Dixon LK, Di Tommaso E, Dimagli A, Sinha S, Sandhu M, Benedetto U, Angelini GD. Impact of sex on outcomes after cardiac surgery: A systematic review and meta-analysis. Int J Cardiol. 2021 Nov 15;343:27-34. doi: 10.1016/j.ijcard.2021.09.011. Epub 2021 Sep 11. — View Citation

Nanegrungsunk D, Patel S, Jan T, Ngai JY. Preoperative Care Practice for Female Cardiac Patients: A Survey From the Society of Cardiovascular Anesthesiologists. J Cardiothorac Vasc Anesth. 2022 Mar;36(3):920-921. doi: 10.1053/j.jvca.2021.09.054. Epub 2021 Oct 3. No abstract available. — View Citation

Peters SAE, Kluin J. Why do women do worse after coronary artery bypass grafting? Eur Heart J. 2021 Dec 28;43(1):29-31. doi: 10.1093/eurheartj/ehab617. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary endpoint	Incidence of mortality (number of patients) specific (coagulation), transfusion products, anesthesia, surgery and cross-clamp times, etc	up to 30 days post-surgery
Primary	Primary endpoint	incidence of cerebrovascualar accident with neurological sequelae (number of patients)	up to 30 days post-surgery
Primary	Primary endpoint	incidence of acute kidney injury (number of patients)	up to 30 days post-surgery
Primary	Primary endpoint	incidence of low cardiac output syndrome, pulmonary and other complications (requiring ventilation > 48 hours post-operatively)	up to 30 days post-surgery
Primary	Primary endpoint	Number of specific (coagulation), transfusion products,	up to 30 days post-surgery
Primary	Primary outcome	Times: surgical, cross-clamp, bypass, anesthetic, intensive care admission, hospital admission, etc.	up to 30 days post-surgery or if still in hospital, until discharge
Secondary	Morbidity and mortality	peroperative and post-operative complications	At 30, 90, 365 days
Secondary	Survival	Long term survival	At 5 and 10 years
Secondary	Health related Quality of life measured by PROMS	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	At 1, 5 and 10 years