An observational study in Female, Male and Surgery,Cardiac, sponsored by Jennifer Breel. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-19.
Sponsored by Jennifer Breel · Observational
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.
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
Jennifer Breel is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Female patients undergoing cardiac surgery
Procedure: Cardiac surgery
Male patients undergoing cardiac surgery
Procedure: Cardiac surgery
Cardiac surgery of all types
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
Primary endpoint
incidence of cerebrovascualar accident with neurological sequelae (number of patients)
Time frame: up to 30 days post-surgery
Primary endpoint
incidence of acute kidney injury (number of patients)
Time frame: up to 30 days post-surgery
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
Primary endpoint
Number of specific (coagulation), transfusion products,
Time frame: up to 30 days post-surgery
Primary outcome
Times: surgical, cross-clamp, bypass, anesthetic, intensive care admission, hospital admission, etc.
Time frame: up to 30 days post-surgery or if still in hospital, until discharge
Morbidity and mortality
peroperative and post-operative complications
Time frame: At 30, 90, 365 days
Survival
Long term survival
Time frame: 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
Time frame: At 1, 5 and 10 years
Plan to share: Undecided
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