Actively Recruiting
The Dose Effect of Activated Clotting Time and Tranexamic Acid on Bleeding in Adult Cardiac Surgery
Led by Taichung Veterans General Hospital · Updated on 2024-02-21
150
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how different doses of tranexamic acid and levels of activated clotting time (ACT) affect bleeding and the need for blood transfusions in adults undergoing cardiac surgery with cardiopulmonary bypass. This study aims to determine whether higher doses of tranexamic acid or lower ACT levels during surgery can reduce bleeding and transfusion amounts. The trial is a randomized, phase 4 interventional study sponsored by Taichung Veterans General Hospital. Participants will be divided into four groups based on two factors: the dose of tranexamic acid (high dose of 50 mg/kg or low dose of 20 mg/kg) and the ACT level maintained during surgery (either 400-600 seconds or above 600 seconds). Tranexamic acid will be administered via a pump starting at the beginning of anesthesia until the full dose is given. Each group combines one dose level with one ACT range to compare outcomes. During the study, medical records of patients who had cardiac surgery between December 1, 2023, and December 31, 2026, will be analyzed. Researchers will measure the volume of bleeding within 24 hours after surgery and the amount of blood transfused during the procedure, averaging about 6 hours. They will also monitor mortality within 30 days. The findings aim to improve monitoring and medication management during cardiac surgeries. Participation involves data collection from medical records without additional procedures.
CONDITIONS
Brief Title
The Effect of ACT and Tranexamic Acid on Bleeding in Cardiac Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients undergoing cardiac surgery with cardiopulmonary bypass
You will not qualify if you...
- Pregnant individuals
- Emergency procedures
- Immune compromised patients
- Patients undergoing aortic surgery
- Patients with end-stage renal disease
- Patients with liver disease
- Patients in critical status
- Incomplete clinical data
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Procedure time (approximately 6 hours)
Participants receive tranexamic acid during cardiac surgery with dosing starting at anesthesia until the full dose is administered. Activated Clotting Time (ACT) is managed at specified levels during cardiopulmonary bypass.
1 in-person visit during surgery
Duration - Up to 30 days
Participants are monitored for blood loss during the first 24 hours after surgery and followed for outcomes including mortality for up to 30 days.
Approximately 1 to 2 visits including immediate post-operative monitoring and follow-up
Trial Site Locations
Total: 2 locations
1
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Actively Recruiting
2
Taichung Veterans General hospital
Taichung, Taiwan, 40705
Actively Recruiting
Research Team
Y
Yung-Szu Wu, MD
Y
Yi-Ting Chang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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