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NCT05957822
Goal-directed vs Preemptive Tranexamic Acid Administration in Non-cardiac Surgery
Phase 4 trial testing TXA in Arthritis Knee in 148 participants. Currently enrolling.
1 December 2024
Quick facts
| Lead sponsor | Konkuk University Medical Center |
|---|---|
| Phase | Phase 4 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 148 |
| Start date | 10 February 2024 |
| Primary completion | 1 December 2024 |
| Estimated completion | 1 January 2025 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- TXA — full drug profile →
- TEG6
Conditions studied
- Arthritis Knee — all drugs for Arthritis Knee →
- Spine Fusion — all drugs for Spine Fusion →
- Prostate Cancer — all drugs for Prostate Cancer →
- Arthritis of Hip — all drugs for Arthritis of Hip →
Sponsor
Konkuk University Medical Center
Who can join
19 and older, any sex, with Arthritis Knee or Spine Fusion. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The present study is a multi-center randomized prospective non-inferiority trial. The study's primary objective is to compare the coagulation profile upon using two different TXA administration strategies: empirical TXA administration vs. viscoelastic test-based goal-directed TXA administration in high-risk non-cardiac surgery. The secondary objectives include comparing the amount of bleeding, 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
1 peer-reviewed publication 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
Verify or expand the search:
- PubMed search for NCT05957822
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of TXA
Trials testing the same drug.
- NCT06781021 — The Effect of Tranexamic Acid Vs Torniquet on Visual Clarity in Knee Arthroscopic ACL Reconstruction · NA · enrolling by invitation
- NCT05138913 — Arthroscopic Treatment Combine With TXA for Elbow Stiffness · NA · unknown
Other recruiting trials for Arthritis Knee
Currently open trials in the same condition.
- NCT07391592 — Post Market Clinical Follow-Up Study for EVOLUTION® NitrX™ Keeled Tibia and EVOLUTION® NitrX™ CS/CR Femur With Cruciate · active not recruiting
- NCT05290818 — Total Versus Robotic Assisted Unicompartmental Knee Replacement · NA · recruiting
- NCT05788016 — Developing an Opioid Taper Intervention Before Total Joint Arthroplasty · NA · recruiting
- NCT06821269 — Functional Recovery After Total Knee Arthroplasty · recruiting
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 NCT05957822 (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: 14 May 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/NCT05957822.
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