NCT06554925

Brief Summary

The aim of this study is to evaluate the differences between females and males undergoing cardiac surgery. The investigators will look at perioperative factors such as adaption of body weight, 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 sort-term (within 30 days) and long-term (90 days and 1 year).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
59mo left

Started Mar 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Mar 2022Mar 2031

Study Start

First participant enrolled

March 1, 2022

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2022

Completed
2.4 years until next milestone

First Posted

Study publicly available on registry

August 15, 2024

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2030

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2031

Last Updated

August 15, 2024

Status Verified

August 1, 2024

Enrollment Period

8 years

First QC Date

March 20, 2022

Last Update Submit

August 12, 2024

Conditions

FemaleMaleSurgery, Cardiac

Keywords

anesthesiasex-specific differencescardiac surgerycare pathways

Outcome Measures

Primary Outcomes (4)

  • Postoperative mortality

    Incidence of perioperative mortality

    Measured at 20 years postoperatively

  • Postoperative mortality

    Incidence of perioperative mortality

    Measured at 30 days postoperatively

  • Postoperative mortality

    Incidence of perioperative mortality

    Measured at 1 year postoperatively

  • Postoperative mortality

    Incidence of perioperative mortality

    Measured at 5 years postoperatively

Secondary Outcomes (4)

  • Postoperative complications (Morbidity)

    Measured at 30 days

  • Postoperative complications (Morbidity)

    Measured at 90 days

  • Postoperative complications (Morbidity)

    Measured at 365 days

  • Development of a predictive risk score using a composite outcome

    Up to 30 days postoperatively

Study Arms (2)

Female

Female sex undergoing cardiac surgery

Procedure: Cardiac surgery

Male

Male sex undergoing cardiac surgery

Procedure: Cardiac surgery

Interventions

Cardiac surgeryPROCEDURE

The difference in males and females undergoing cardiac surgery of all types

FemaleMale

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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 cardiothoracic surgery from 1998 in the AUMC, location VUmc until June 2021. Observational retrospective data collection from the mandatory Quality Assurance database of the Netherlands Heart Registry, supplemented with data from the electronic patient files (EPIC).

You may qualify if:

  • Patients \> 18 years
  • All patients who underwent cardiac surgery from 1 January 1998 in the AUMC, location VUmc, until 1 June 2021.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academic Medical Center

Amsterdam, North Holland, 1105AZ, Netherlands

RECRUITING

Related 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.

    PMID: 34606298BACKGROUND

  • 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.

    PMID: 34520795BACKGROUND

  • 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.

    PMID: 34776353BACKGROUND

  • 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.

    PMID: 34524421BACKGROUND

MeSH Terms

Interventions

Cardiac Surgical Procedures

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Officials

  • Markus W Hollmann, Professor

    Anesthesiology and Pain Medicine, Amsterdam Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer S Breel, MSc

CONTACT

+31610019257j.s.breel@amsterdamumc.nl

Susanne Eberl, PhD

CONTACT

+31610019257s.eberl@amsterdamumc.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research coordinator

Study Record Dates

First Submitted

March 20, 2022

First Posted

August 15, 2024

Study Start

March 1, 2022

Primary Completion (Estimated)

March 1, 2030

Study Completion (Estimated)

March 1, 2031

Last Updated

August 15, 2024

Record last verified: 2024-08

Locations

NL(1)