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NCT04731558 | RECRUITING | Liver Cancer


Pre- Vs Postoperative Thromboprophylaxis for Liver Resection
Sponsor:

Helsinki University Central Hospital

Information provided by (Responsible Party):

Ville Sallinen

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.

Condition or disease

Liver Cancer

Surgery

Thrombosis, Deep Vein

Embolism, Pulmonary

Bleeding

Intervention/treatment

enoxaparin or tinzaparin or dalteparin

No intervention

Phase

PHASE4

Study Type : INTERVENTIONAL
Estimated Enrollment : 1012 participants
Masking : TRIPLE
Primary Purpose : PREVENTION
Official Title : Pre- Vs Postoperative Thromboprophylaxis for Liver Resection - a Prospective, Multicenter, Randomized Controlled Trial
Actual Study Start Date : 2021-02-10
Estimated Primary Completion Date : 2027-02
Estimated Study Completion Date : 2027-03

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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)

Pre- Vs Postoperative Thromboprophylaxis for Liver Resection

Location Details

NCT04731558


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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


RECRUITING

Finland,

Helsinki University Hospital

Helsinki, Finland,

RECRUITING

Finland,

Kuopio University Hospital

Kuopio, Finland,

NOT YET RECRUITING

Finland,

Oulu University Hospital

Oulu, Finland,

RECRUITING

Finland,

Tampere University Hospital

Tampere, Finland,

NOT YET RECRUITING

Finland,

Turku University Hospital

Turku, Finland,

RECRUITING

Norway,

Oslo University Hospital

Oslo, Norway,

RECRUITING

Norway,

University Hospital of North Norway

Tromsø, Norway,

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