Tranexamic Acid Administration Strategies in Cardiovascular Surgery: Goal-directed Tranexamic Acid Administration Based on Viscoelastic Test vs. Empirical Tranexamic Acid Administration

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The present study is a multi-center randomized prospective placebo-controlled non-inferiority trial. The study's primary objective is to compare the amounts of postoperative bleeding using two different TXA administration strategies: empirical TXA administration vs. viscoelastic test-based goal-directed TXA administration in cardiovascular surgery. The secondary objectives include comparing the incidents of hyper-fibrinolysis, thromboembolic complications, and postoperative seizures. Researchers assumed that goal-directed tranexamic acid (TXA) administration using viscoelastic field tests would not be inferior to the empirical TXA administration strategy in reducing postoperative bleeding and hyper-fibrinolysis. It also would be beneficial in lowering TXA-induced thromboembolic complications and seizures.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• patients who will undergo elective cardiovascular surgery employing cardiopulmonary bypass

• patients who provide written informed consent

Locations
Other Locations
Republic of Korea
Asan Medical Center
RECRUITING
Seoul
Konkuk University Medical Center
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Contact Information
Primary
Tae-Yop Kim, MD PhD
taeyop@gmail.com
+82-10-8811-6942
Time Frame
Start Date: 2023-08-01
Estimated Completion Date: 2025-06-30
Participants
Target number of participants: 764
Treatments
Active_comparator: Empirical 1: TXA and Placebo administration
Tranexamic acid administration, regardless of the result of rotational thromboelastometry.~Placebo administration, at LI60 \< 85 % or A10\< 40 mm in EXTEM of rotational thromboelastometry
Active_comparator: Empirical 2: TXA administration
Tranexamic acid administration, regardless of the result of rotational thromboelastometry.~Placebo discard, at LI60 ≥ 85% or A10 ≥ 40 mm in EXTEM of rotational thromboelastometry
Experimental: Goal-directed 1: Placebo administration
Placebo administration, regardless of the result of rotational thromboelastometry.~Tranexamic acid administration at LI60 \< 85 % or A10 \< 40 mm in EXTEM of rotational thromboelastometry
Experimental: Goal-directed 2: TXA and Placebo administration
Placebo administration, regardless of the result of rotational thromboelastometry.~Tranexamic acid discard at LI60 ≥ 85% or A10 ≥ 40 mm in EXTEM of rotational thromboelastometry
Related Therapeutic Areas
Sponsors
Collaborators: Samsung Medical Center, Asan Medical Center, Korea Health Industry Development Institute, Helptrial
Leads: Konkuk University Medical Center

This content was sourced from clinicaltrials.gov