RECRUITINGPhase 4INTERVENTIONAL

Pre- Vs. Postoperative Thromboprophylaxis in Pancreatic Surgery

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: All patients undergoing either 1. pancreaticoduodenectomy or total pancreatectomy (for any indication) or 2. distal pancreatectomy for suspicion of cancer Who Should NOT Join This Trial: 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 willing to sign a consent form 6. Pancreatic resection not performed (removed from analyses after randomization) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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)

Treatments Being Tested

DRUG

enoxaparin/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).

Locations (5)

Sunnybrook Health Sciences Centre

Toronto, Canada

Helsinki University Hospital

Helsinki, Finland

Oulu University Hospital

Oulu, Finland

Tampere University Hospital

Tampere, Finland

Oslo University Hospital

Oslo, Norway