NCT05245877 Pre- Vs. Postoperative Thromboprophylaxis in Pancreatic Surgery
| NCT ID | NCT05245877 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Helsinki University Central Hospital |
| Condition | Pancreas Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 800 participants |
| Start Date | 2022-08-17 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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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 800 participants in total. It began in 2022-08-17 with a primary completion date of 2026-08.
⚠ 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 pancreatic surgery can be commenced either preoperatively or postoperatively. Despite a clear trade-off between thrombosis and bleeding in pancreatic surgery patients, there is no international consensus when thrombosis prophylaxis should be commenced in patients undergoing pancreatic surgery. 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 pancreatic surgery. On the contrary, Dutch guidelines recommend postoperative thromboprophylaxis only, because of lack of evidence for preoperative thromboprophylaxis. Enhanced Recovery After Surgery (ERAS) Society Guidelines recommend preoperative thromboprophylaxis in pancreatic 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 pancreatic surgery. The aim of this study is to compare pre- and postoperatively initiated thromboprophylaxis regimens in pancreatic surgery in a randomized controlled trial.
Eligibility Criteria
Inclusion Criteria: All patients undergoing either 1. pancreaticoduodenectomy or total pancreatectomy (for any indication) or 2. distal pancreatectomy for suspicion of cancer Exclusion Criteria: 1. Patient on anticoagulative medication (heparin, low-molecular weight heparin, warfarin, direct oral anticoagulants) during the month (30 days) preceding surgery 2. Emergency operation (e.g. for trauma, infection or pancreatitis) 3. Age \< 18 years 4. Allergy or other contraindication to planned low-molecular weight heparin 5. Inability to give written informed consent 6. Pancreatic resection not performed (removed from analyses after randomization)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05245877 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 120 Years, studying Pancreas 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 NCT05245877 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 NCT05245877 currently recruiting?
Yes, NCT05245877 is actively recruiting participants. Contact the research team at ville.sallinen@helsinki.fi for enrollment information.
Where is the NCT05245877 trial being conducted?
This trial is being conducted at Toronto, Canada, Helsinki, Finland, Oulu, Finland, Tampere, Finland and 1 additional location.
Who is sponsoring the NCT05245877 clinical trial?
NCT05245877 is sponsored by Helsinki University Central Hospital. The trial plans to enroll 800 participants.
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