Clinical trial · Interventional
Goal-directed vs Preemptive Tranexamic Acid Administration in Non-cardiac Surgery
Comparison of Viscoelastic Test-guided and Preemptive Tranexamic Acid Administration Strategies in High-risk Non-cardiac Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Arthritis Knee | — | UNRESOLVED | — |
| Arthritis of Hip | — | UNRESOLVED | — |
| Hepatic Cancer | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Spine Fusion | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TEG6 | Diagnostic Test | — | UNRESOLVED |
| TXA | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- TXA empirical
- description
- Empirical Tranexamic acid (TXA) administration after the anesthesia induction
- interventionNames
- Drug: TXA
- type
- EXPERIMENTAL
- label
- TXA TEG6-triggered
- description
- When LY30≥3% or MA\<54 mm in CRT of TEG6, Tranexamic acid (TXA) is administered
- interventionNames
- Drug: TXA
- Diagnostic Test: TEG6
- type
- EXPERIMENTAL
- label
- TXA TEG6-non-triggered
- description
- When LY30\<3% or MA ≥ 54 mm in CRT of TEG6, Tranexamic acid (TXA) is not administered
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria patients undergoing following surgery * spinal fusion surgery with more than 2 levels * total hip arthroplasty * total knee arthroplasty * open prostatectomy * hepatectomy Exclusion Criteria: * pregnancy * refusal of allogenic blood transfusion * taking thrombin * history of thromboembolic and familial hypercoagulability disease * recent history of myocardial infarction or ischemic cerebral infarction (within 90 days) * hypersensitive to TXA * histroy of convulsion or epilepsy * taking hemodialysis * history of Heparin-induced thrombocytopenia
References
Publications (0)
Data not yet available