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

ConditionsFemaleMaleSurgery,Cardiac
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJennifer Breel

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial population

The study population will consist of male and female patients, 18 years and older. The study group consists of all patients who underwent cardiac surgery from 1 January 2016 onwards, in either of the centres (AMC or VUmc). The registry will continue for at least 10 years after the inclusion of the last patient.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Cardiac surgery

    Procedure/Surgery

    Cardiac surgery of all types

Treatment groups

5,500 Participants
are divided into 2 treatment groups
Group A: Female1 intervention
Group B: Male1 intervention

Trial outcomes

Primary outcomes

1

Primary endpoint

Incidence of mortality (number of patients) specific (coagulation), transfusion products, anesthesia, surgery and cross-clamp times, etc

Time frame
up to 30 days post-surgery
2

Primary endpoint

incidence of cerebrovascualar accident with neurological sequelae (number of patients)

Time frame
up to 30 days post-surgery
3

Primary endpoint

incidence of acute kidney injury (number of patients)

Time frame
up to 30 days post-surgery
4

Primary endpoint

incidence of low cardiac output syndrome, pulmonary and other complications (requiring ventilation \> 48 hours post-operatively)

Time frame
up to 30 days post-surgery

Secondary outcomes

1

Morbidity and mortality

peroperative and post-operative complications

Time frame
At 30, 90, 365 days
2

Survival

Long term survival

Time frame
At 5 and 10 years
3

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

Time frame
At 1, 5 and 10 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jennifer Breel

Lead sponsor

Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)

Sponsor institution

Source ClinicalTrials.gov
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