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NCT05708690
Topical Effect of Tranexamic Acid in Postoperative Bleeding and Blood Products Transfusion After Cardiac Surgery
Phase 4 trial testing Tranexamic Acid 100 MG/ML in Coronary Artery Disease in 132 participants. Completed in 6 January 2023.
31 December 2022
Quick facts
| Lead sponsor | Indonesia University |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 132 |
| Start date | 1 October 2022 |
| Primary completion | 31 December 2022 |
| Estimated completion | 6 January 2023 |
| Sites | 1 location across Indonesia |
Drugs / interventions tested
- Tranexamic Acid 100 MG/ML — full drug profile →
- normal saline
Conditions studied
- Coronary Artery Disease — all drugs for Coronary Artery Disease →
- Valvular Heart Disease — all drugs for Valvular Heart Disease →
- Surgical Blood Loss — all drugs for Surgical Blood Loss →
Sponsor
Indonesia University
Who can join
Adults 18 to 75, any sex, with Coronary Artery Disease or Valvular Heart Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a single-center, double-blind, randomized controlled trial (RCT) comparing two groups of application of topical dose of tranexamic acid (TxA) versus placebo in patients undergoing coronary artery bypass graft (CABG), off pump coronary bypass graft cardiac surgery (OPCAB), and adult heart valve surgery. The primary outcomes of this study comprised of two parameters; post operative bleeding and blood product transfusion. The primary outcomes were assessed during the operation, until 48-hour post operative.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05708690
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT04192643 — INTERVENTION WITH TRANEXAMIC ACID TO REDUCE HAEMORRHAGE DURING LAPAROSCOPIC MYOMECTOMY · NA · unknown
- NCT03934047 — Visual Field Infiltration of Tranexamic Acid Reduced the Blood Loss in Total Knee Arthroplasty · NA · unknown
- NCT03690037 — Investigating the Effect of Intravenous and Oral Tranexamic Acid on Blood Loss After Primary Hip and Knee Arthroplasty · Phase 4 · completed
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Currently open trials in the same condition.
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Other Indonesia University trials
Trials by the same sponsor.
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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 NCT05708690 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Indonesia University
- Last refreshed: 1 February 2023
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/NCT05708690.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing