RecruitingPhase 4NCT05245877

Pre- Vs. Postoperative Thromboprophylaxis in Pancreatic Surgery

Pre- Vs. Postoperative Thromboprophylaxis in Pancreatic Surgery - a Prospective, Multicenter, Randomized Controlled Trial (PREPOSTEROUS Pancreas Trial)

Sponsor

Helsinki University Central Hospital

Enrollment

800 participants

Start Date

Aug 17, 2022

Study Type

INTERVENTIONAL

Conditions

Surgery Pancreas Cancer Thrombosis Bleeding Pancreas Neoplasm

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

Min Age: 18 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two timing approaches for giving blood clot prevention medication (anticoagulation) to patients undergoing pancreatic surgery — one group starts the medication before the operation, and the other starts after. Blood clots are a serious risk after major abdominal surgery, and this trial aims to find the safer and more effective approach. **You may be eligible if...** - You are 18 or older - You are scheduled for a major pancreatic surgery (such as a Whipple procedure, total pancreatectomy, or distal pancreatectomy for suspected cancer) **You may NOT be eligible if...** - You are already on blood thinners (such as warfarin, heparin, or newer oral anticoagulants) in the month before surgery - Your surgery is an emergency - You have an allergy or other contraindication to the planned blood thinner medication - You are unable to give written consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGenoxaparin/tinzaparin/dalteparin

Patients randomized to the preoperative thromboprophylaxis will have their thromboprophylaxis initiated approximately 2-14 hours prior to the planned pancreatic surgery skin incision (depending on the center's current practice and logistics). Thromboprophylaxis can be initiated using enoxaparin (20 - 40 mg), tinzaparin (2500 - 4500 IU), or dalteparin (2500 - 5000 IU), with the dose based on patient's renal function according to the local standard of care. A center may reduce the dose 25-50% if the dose is given very close to the skin incision (i.e. at the morning of the operation instead of the evening before the operation).