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The Effect of Local Application of Tranexamic Acid Versus Placebo on Postoperative Complications in Plastic Surgery

Study acronym: TRANOP
StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Trial sites expanded: 1 → 11 locationsv4 Show 4 more changesShow less
    • Start date: Oct 1, 2024 to Sep 18, 2024
    • Eligibility criteria shortened, about 7 words
    • Secondary endpoints revised (5)
    • Collaborators: 12 to 11
  2. Start date changed from estimate of Oct 2024 to Oct 1, 2024
    • Study title revised
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date: May 1, 2024 to Oct 2024
    • Study sites: 0 to 1
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Study objective: This is a study to investigate whether applying the drug tranexamic acid (TXA) onto a surgical wound surface may affect the incidence of surgical complications such as re-bleeding needing intervention, wound complications such as infection, wound rupture or seroma, or if it may increase the risk of blood clots. Eligible patients: Patients undergoing plastic surgical procedures with wounds that would normally receive application of TXA to reduce bleeding after surgery. Study intervention: Participants will receive a single local application of study drug onto their wound surfaces at the end of surgery. Study drug will be identical looking ampoules which contain either TXA or placebo (saline). Neither participants nor study personnel will know the contents of the ampoules.
Trial Details
NCT Number NCT06270407
Lead Sponsor St. Olavs Hospital
Collaborators: Smerud Medical Research International AS, Oslo University Hospital, Haraldsplass Deaconess Hospital, Helse Stavanger HF, University Hospital of North Norway, Helsinki University Central Hospital, Vejle Hospital, Bærum sykehus, Sykehuset SNR, Hamar sykehus, Tynset Sykehus
Conditions
(from sponsor)		 Surgical Complication
Enrollment 3,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov