NCT04731558 Pre- Vs Postoperative Thromboprophylaxis for Liver Resection
| NCT ID | NCT04731558 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Helsinki University Central Hospital |
| Condition | Liver Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,012 participants |
| Start Date | 2021-02-10 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 1,012 participants in total. It began in 2021-02-10 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * All patients undergoing liver resection Exclusion Criteria: * Patient on anticoagulative medication (heparin, low-molecular weight heparin, warfarin, direct oral anticoagulants) during last month pre-surgery * Emergency operation (e.g. for trauma or infection) * Age \< 18 years * Allergy or other contraindication to planned low-molecular weight heparin * Inability to give written informed consent * Liver resection not performed (removed from analyses after randomization)
Frequently Asked Questions
Who can join the NCT04731558 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Liver Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04731558 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04731558 currently recruiting?
Yes, NCT04731558 is actively recruiting participants. Visit ClinicalTrials.gov or contact Helsinki University Central Hospital to inquire about joining.
Where is the NCT04731558 trial being conducted?
This trial is being conducted at Helsinki, Finland, Kuopio, Finland, Oulu, Finland, Tampere, Finland and 1 additional location.
Who is sponsoring the NCT04731558 clinical trial?
NCT04731558 is sponsored by Helsinki University Central Hospital. The trial plans to enroll 1,012 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.