NCT Number: NCT06175650
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Amsterdam, North Holland, 1105 AZ, Netherlands
Location status: Recruiting
Jennifer S Breel, MPA,MSc.
CONTACT
Jennifer S Breel, MPA,MSc.
SUB_INVESTIGATOR
Susanne Eberl, MD, PhD
CONTACT
+31205669111 ext. 62533
Susanne Eberl, MD,PhD
PRINCIPAL_INVESTIGATOR
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
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cardiac surgery of all types
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
Time frame: up to 30 days post-surgery
incidence of cerebrovascualar accident with neurological sequelae (number of patients)
Time frame: up to 30 days post-surgery
incidence of acute kidney injury (number of patients)
Time frame: up to 30 days post-surgery
incidence of low cardiac output syndrome, pulmonary and other complications (requiring ventilation > 48 hours post-operatively)
Time frame: up to 30 days post-surgery
Number of specific (coagulation), transfusion products,
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.
Time frame: At 30, 90, 365 days
peroperative and post-operative complications
Time frame: At 5 and 10 years
Long term survival
Time frame: At 1, 5 and 10 years
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
Contact information is provided by the study sponsor or research team.
Jennifer S Breel, MSc
CONTACT
Susanne Eberl, PhD
CONTACT
Jennifer Breel
Other
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
Acronym: F-ERAS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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