Pre- Vs. Postoperative Thromboprophylaxis in Pancreatic Surgery

NCT ID: NCT05245877

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-17
• Study Completion Date: 2026-09-30

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.

Conditions

Pancreas Cancer; Pancreas Neoplasm; Surgery; Thrombosis; Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Preoperative thromboprophylaxis

Preoperatively initiated tromboprophylaxis

Group Type: EXPERIMENTAL

enoxaparin/tinzaparin/dalteparin

Intervention Type: DRUG

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).

Postoperative thromboprophylaxis

Postoperatively initiated thromboprophylaxis

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helsinki University Central Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ville Sallinen

Primary investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sunnybrook Health Sciences Centre

Toronto, , Canada

Site Status: RECRUITING

Helsinki University Hospital

Helsinki, , Finland

Site Status: RECRUITING

Oulu University Hospital

Oulu, , Finland

Site Status: RECRUITING

Tampere University Hospital

Tampere, , Finland

Site Status: RECRUITING

Oslo University Hospital

Oslo, , Norway

Site Status: RECRUITING

Countries

Canada; Finland; Norway

Central Contacts

Ville Sallinen, MD,PhD

Role: CONTACT

ville.sallinen@helsinki.fi

+358-9-4711

Facility Contacts

Paul Karanicolas

Role: primary

paul.karanicolas@sunnybrook.ca

416-480-6100

Tea Kontio, MD,PhD

Role: primary

tea.kontio@hus.fi

Minna Nortunen, MD, PhD

Role: primary

minna.nortunen@ppshp.fi

+358 8 3152011

Johanna Laukkarinen, MD, PhD, Professor

Role: primary

johanna.laukkarinen@pirha.fi

+358 3 311 61

Knut J Labori, MD, PhD, Professor

Role: primary

uxknab@ous-hf.no

+47 22 11 80 80

Other Identifiers

HYKS-PREPOSTEROUS2

Identifier Type: -

Identifier Source: org_study_id