FemaleF-ERASNCT06175650
Towards a Sex-specific "Female Enhanced Recovery After Cardiac Surgery'' (F-ERAS) Pathway:
An observational study of Female and Male, run by Jennifer Breel at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Female, Male, Surgery,Cardiac
- What is being tested?
- Cardiac surgery
- Type of treatment
- Surgery or procedure
- How many people
- 5,500 participants
- Where
- 1 siteNetherlands
- Study dates
- 21 Nov 2023to 21 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study 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.
Who may be able to join
- 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
Who cannot join
- Patients who object to the re-use of their care data or do not give consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Academic Medical Center
Amsterdam, North Holland, 1105 AZ
Jennifer S Breel, MPA,MSc., +316 1001 9257, j.s.breel@amsterdamumc.nl
Susanne Eberl, MD, PhD, +31205669111 ext. 62533, s.eberl@amsterdamumc.nl
About this study
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
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.
Read the 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
- Being tested
- Cardiac surgery
- Keywords
- Anesthesia, Quality of Life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac surgeryProcedure or surgery
Cardiac surgery of all types
| Study group | Role | What they receive |
|---|---|---|
| Female | Female patients undergoing cardiac surgery Receives: Procedure: Cardiac surgery | |
| Male | Male patients undergoing cardiac surgery Receives: Procedure: Cardiac surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint
Incidence of mortality (number of patients) specific (coagulation), transfusion products, anesthesia, surgery and cross-clamp times, etc
Measured: up to 30 days post-surgery
Primary endpoint
incidence of cerebrovascualar accident with neurological sequelae (number of patients)
Measured: up to 30 days post-surgery
Primary endpoint
incidence of acute kidney injury (number of patients)
Measured: up to 30 days post-surgery
Primary endpoint
incidence of low cardiac output syndrome, pulmonary and other complications (requiring ventilation > 48 hours post-operatively)
Measured: up to 30 days post-surgery
Primary endpoint
Number of specific (coagulation), transfusion products,
Measured: up to 30 days post-surgery
Primary outcome
Times: surgical, cross-clamp, bypass, anesthetic, intensive care admission, hospital admission, etc.
Measured: up to 30 days post-surgery or if still in hospital, until discharge
Secondary outcomes (3)
Morbidity and mortality
peroperative and post-operative complications
Measured: At 30, 90, 365 days
Survival
Long term survival
Measured: At 5 and 10 years
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
Measured: At 1, 5 and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study start21 Nov 2023
- Primary completion21 Nov 2025 (estimated)
- Study completion21 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jennifer Breel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jennifer Breel, Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
- Investigators
- Markus W Hollmann, Professor, Principal investigator, Anesthesiology and Pain Medicine, Amsterdam Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06175650
- Sponsor's protocol ID
- W22_051 # 22.082
- Acronym
- F-ERAS
- Status last verified
- Dec 2023
- First submitted
- 20 Mar 2022
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34606298Dixon 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.
PubMed 34520795Nanegrungsunk 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.
PubMed 34776353Peters 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.
PubMed 34524421
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06175650
- Acronym / sponsor ID
- F-ERAS / W22_051 # 22.082
- Conditions
- Female, Male, Surgery,Cardiac
- Keywords
- Anesthesia, Quality of Life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,500 participants (estimated)
- Lead sponsor
- Jennifer BreelUniversity, hospital or other
- Study start
- 21 Nov 2023 (actual)
- Primary completion
- 21 Nov 2025 (estimated)
- Study completion
- 21 Nov 2026 (estimated)
- First posted
- 19 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Female | – | Procedure: Cardiac surgeryFemale patients undergoing cardiac surgery |
| Male | – | Procedure: Cardiac surgeryMale patients undergoing cardiac surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who object to the re-use of their care data or do not give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac surgeryCardiac surgery of all types | Procedure or surgery | Female, Male |
Primary outcome
Primary endpoint
Time frame: up to 30 days post-surgery
Incidence of mortality (number of patients) specific (coagulation), transfusion products, anesthesia, surgery and cross-clamp times, etc
Primary endpoint
Time frame: up to 30 days post-surgery
incidence of cerebrovascualar accident with neurological sequelae (number of patients)
Primary endpoint
Time frame: up to 30 days post-surgery
incidence of acute kidney injury (number of patients)
Primary endpoint
Time frame: up to 30 days post-surgery
incidence of low cardiac output syndrome, pulmonary and other complications (requiring ventilation > 48 hours post-operatively)
Primary endpoint
Time frame: up to 30 days post-surgery
Number of specific (coagulation), transfusion products,
Primary outcome
Time frame: 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.
3 secondary outcomes
Morbidity and mortality
Time frame: At 30, 90, 365 days
Survival
Time frame: At 5 and 10 years
Health related Quality of life measured by PROMS
Time frame: At 1, 5 and 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Background: PubMed 34606298Cho 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.
- Background: PubMed 34520795Dixon 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.
- Background: PubMed 34776353Nanegrungsunk 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.
- Background: PubMed 34524421Peters 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Markus W Hollmann, Professor principal investigator
Anesthesiology and Pain Medicine, Amsterdam Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Female and Male, run by Jennifer Breel at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer S Breel, MSc (+31610019257, j.s.breel@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint (time frame: up to 30 days post-surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06175650, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2023.