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NCT03714360
The Effect of Tranexamic Acid. A Randomised Study of Patients Undergoing Elective Lumbar Spine Surgery.
Phase 4 trial testing Tranexamic Acid in Pharmacological Action in 250 participants. Completed in 16 August 2016.
16 August 2016
Quick facts
| Lead sponsor | Mikkel Østerheden Andersen |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 250 |
| Start date | 19 October 2015 |
| Primary completion | 16 August 2016 |
| Estimated completion | 16 August 2016 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Tranexamic Acid (Tranexamic Acid) — full drug profile →
- Sodium Chloride 0,9%
Conditions studied
- Pharmacological Action — all drugs for Pharmacological Action →
Sponsor
Mikkel Østerheden Andersen
Who can join
Eligibility, any sex, with Pharmacological Action. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In this randomized double blind placebo controlled study of tranexamic acid during minor spinal surgery, mean postoperative blood loss in the patients who received TXA was statistically significantly lower compared to placebo.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Double-blind, randomized controlled trial of tranexamic acid in minor lumbar spine surgery: no effect on operative time, intraoperative blood loss, or complications.
Elmose S, Andersen MØ, Andresen EB, Carreon LY. · · 2019 · cited 18× · PMID 30978683 · DOI 10.3171/2019.1.spine1814
Verify or expand the search:
- PubMed search for NCT03714360
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Tranexamic Acid
Trials testing the same drug.
- NCT07501884 — REDUCER Trial (TXA in Urethroplasty) · Phase 4 · not yet recruiting
- NCT07460518 — Tranexamic Acid for Bleeding Reduction During TURP Surgery · Phase 4 · not yet recruiting
- NCT07390799 — Prophylactic Tranexamic Acid in Low-Risk Repeat Cesarean Delivery: A Randomized Controlled Trial · NA · not yet recruiting
- NCT07078942 — Prophylactic Intravenous Tranexamic Acid on Perioperative Blood Loss in Pregnant Women Undergoing Cesarean Section · Phase 4 · not yet recruiting
- NCT07263841 — Comparison of Effectiveness of Tranexamic Acid Mesotherapy Versus Glutathione Mesotherapy in Post Burn Facial Hyperpigme · Phase 2 · active not recruiting
Other recruiting trials for Pharmacological Action
Currently open trials in the same condition.
- NCT06324370 — Exploratory Pharmacokinetic Study of Virgin Coconut Oil (VCO) · NA · active not recruiting
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 NCT03714360 (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 Mikkel Østerheden Andersen
- Last refreshed: 31 January 2025
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/NCT03714360.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing