Actively Recruiting

Age: 18Years +
All Genders
ID06554925

SEx-specific Differences in Cardiac Surgery Patients (SECS). A Retrospective Registration and Evaluation of Characteristics and Perioperative Management of Cardiac Surgery Patients

Led by Jennifer Breel · Updated on 2024-08-15

10000

Participants Needed

1

Research Sites

52 weeks

Total Duration

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AI-Summary

What this Trial Is About

Researchers are studying the differences between females and males undergoing cardiac surgery to understand how sex-specific factors affect perioperative care and outcomes. The study focuses on various perioperative elements such as body weight adaptation, medical history, drug processing, blood transfusions, blood clotting, heart-lung machine use, heart function, medication needs, risk and outcome scores, as well as short-term and long-term morbidity and mortality. This research aims to identify factors that may cause worse outcomes in females after cardiac surgery and improve their care. The study compares female and male patients undergoing all types of cardiac surgery by collecting and analyzing a wide range of perioperative data. This observational study does not involve experimental treatments but reviews existing records of patients treated between January 1998 and June 2021 at a specific medical center. The goal is to build a database of perioperative parameters to find differences that may require tailored care pathways for females. Participants are patients aged 18 years and older who have undergone cardiac surgery during the specified period. The research team will evaluate mortality rates at multiple time points: 30 days, 1 year, 5 years, and 20 years after surgery. They will also assess postoperative complications at 30, 90, and 365 days, and develop a predictive risk score based on composite outcomes within 30 days. This long-term follow-up aims to enhance understanding of sex-specific risks and improve recovery after cardiac surgery.

CONDITIONS

Brief Title

SEx-specific Differences in Cardiac Surgery Patients (SECS).

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients older than 18 years
  • Patients who underwent cardiac surgery at the specified medical center between January 1, 1998, and June 1, 2021
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Hospital stay duration following surgery

Participants undergo cardiac surgery and receive immediate post-operative care.

Hospital visits during surgery and immediate recovery

Post-operative Follow-up

Duration - Up to 20 years postoperatively

Participants are monitored for post-operative complications and mortality over short and long term after surgery.

Follow-up visits at 30 days, 90 days, 1 year, 5 years, and up to 20 years postoperatively

Trial Site Locations

Total: 1 location

1

Academic Medical Center

Amsterdam, North Holland, Netherlands, 1105AZ

Actively Recruiting

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Research Team

J

Jennifer S Breel, MSc

S

Susanne Eberl, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Preoperative Care Practice for Female Cardiac Patients: A Survey From the Society of Cardiovascular Anesthesiologists.

Danop Nanegrungsunk, Shayna Patel, Thomas Jan...

https://pubmed.ncbi.nlm.nih.gov/34776353