Last reviewed · How we verify
NCT05806346
Goal-directed vs. Empirical Tranexamic Acid Administrationin Cardiovascular Surgery
NA trial testing TXA administration in Heart Diseases in 764 participants. Currently enrolling.
30 April 2025
Quick facts
| Lead sponsor | Konkuk University Medical Center |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | diagnostic |
| Enrollment | 764 |
| Start date | 1 August 2023 |
| Primary completion | 30 April 2025 |
| Estimated completion | 30 June 2025 |
| Sites | 3 locations across South Korea |
Drugs / interventions tested
- TXA administration — full drug profile →
- Placebo administration — full drug profile →
Conditions studied
- Heart Diseases — all drugs for Heart Diseases →
- Vascular Diseases — all drugs for Vascular Diseases →
- Transfusion Related Complication — all drugs for Transfusion Related Complication →
- Coagulation Disorder, Blood — all drugs for Coagulation Disorder, Blood →
Sponsor
Konkuk University Medical Center
Who can join
19 and older, any sex, with Heart Diseases or Vascular Diseases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Viscoelastic haemostatic assays to guide therapy in elective surgery: an updated systematic review and meta-analysis.
Dias JD, Levy JH, Tanaka KA, Zacharowski K, et al · · 2025 · cited 6× · PMID 39544008 · DOI 10.1111/anae.16463 -
A multi-center, double-blind, placebo-controlled, randomized, parallel-group, non-inferiority study to compare the efficacy of goal-directed tranexamic acid administration based on viscoelastic test versus preemptive tranexamic acid administration on postoperative bleeding in car
Nam JS, Oh CS, Kim JY, Choi DK, et al · · 2024 · PMID 39334224 · DOI 10.1186/s13063-024-08467-1
Verify or expand the search:
- PubMed search for NCT05806346
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other Konkuk University Medical Center trials
Trials by the same sponsor.
- NCT06637943 — Comparison of the Diagnosis Time of VET and SCL in Patients With Intraoperative Coagulopathy · not yet recruiting
- NCT06144112 — Fibrinogen Concentrates Versus Cryoprecipitate in Liver Transplant Surgery · Phase 4 · not yet recruiting
- NCT06664320 — Mild ANH on Pre-bypass Coagulation Function During Cardiac Surgery · NA · not yet recruiting
- NCT06574594 — Effect of MTX Discontinuation on Shingrix Response in RA · NA · recruiting
- NCT06144099 — Prothrombin Complex Concentrate vs Fresh Frozen Plasma in Goal-directed Bleeding Management in Non-cardiac Surgery · Phase 4 · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05806346 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Konkuk University Medical Center
- Last refreshed: 18 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05806346.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing