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Pre- Vs Postoperative Thromboprophylaxis for Liver Resection

Study acronym: PREPOSTEROUS
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Feb 2025 to Feb 2027
    • Study sites: 6 to 7
    • Study completion date: Mar 2025 to Mar 2027
    v4
  2. Site details revised at 2 of 6 sitesv3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 2021 to Feb 10, 2021
    • Site details revised at 6 of 6 sites
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Thromboprophylaxis for liver surgery can be commenced either preoperatively or postoperatively. Despite a clear trade-off between thrombosis and bleeding in liver surgery patients, there is no international consensus when thrombosis prophylaxis should be commenced in patients undergoing liver surgery. As far as we know, there are no prospective randomized trials in this field, and current guidelines are unfortunately based on very low quality evidence, that is, a few retrospective studies and expert opinion. Both American and European thromboprophylaxis guidelines for abdominal cancer surgery support the preoperative initiation of thromboprophylaxis, but these guidelines do not specifically address the increased bleeding risk associated with liver surgery. On the contrary, Dutch guidelines recommend postoperative thromboprophylaxis only, because of lack of evidence for preoperative thromboprophylaxis. Traditionally, many liver surgery units have been reluctant in using preoperative thromboprophylaxis due to the potentially increased risk of bleeding complications. Enhanced Recovery After Surgery (ERAS) Society Guidelines recommend preoperative thromboprophylaxis in liver surgery, but the guidelines provide no supporting evidence for this recommendation. Overall, the amount of evidence is scarce and somewhat contradictory in this clinically relevant field of thromboprophylaxis in liver surgery. The aim of this study is to compare pre- and postoperatively initiated thromboprophylaxis regimens in liver surgery in a randomized controlled trial.
Trial Details
NCT Number NCT04731558
Lead Sponsor Helsinki University Central Hospital
Collaborators: Academy of Finland, The Finnish Medical Association
Conditions
(from sponsor)		 Liver Cancer, Surgery, Thrombosis, Deep Vein, Embolism, Pulmonary, Bleeding
Related terms Hemorrhage, Liver Neoplasms, Pulmonary Embolism, Venous Thrombosis
Enrollment 1,012 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov