Pre- vs. postoperative thromboprophylaxis for liver resection – a prospective, multicenter, randomized controlled trial

Pre- vs. postoperative thromboprophylaxis for liver resection – a prospective, multicenter, randomized controlled trial - PREPOSTEROUS

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-002323-15-NO

Enrollment

1012

Registered

2021-03-29

Start date

2021-12-10

Completion date

Unknown

Last updated

2021-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous thromboembolism

Interventions

Trade Name: Fragmin Product Name: Fragmin Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Dalteparin sodium Other descriptive name: DALTEPARIN SODIUM Concentrati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients undergoing liver resection Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 160 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 240

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess whether preoperatively initiated thromboprophylaxis prevents postoperative venous thromboembolism in patients undergoing liver surgery compared to postoperative initiated thromboprophylaxis;Secondary Objective: To assess bleeding and other postoperative complications;Primary end point(s): Venous thromboembolisms, number of patients, within 30 days from liver resection Venous thromboembolism is defined as either 1) symptomatic deep venous thromboembolism (includes all deep veins e.g. all extremities, portal vein, and superior mesenteric) diagnosed using ultrasound or computed tomography or magnetic resonance imaging, or in re-laparatomy/surgery, 2) pulmonary embolism diagnosed using computed tomography, magnetic resonance imaging, or lung perfusion imaging, or 3) death due to venous thromboembolism ;Timepoint(s) of evaluation of this end point: Within 30 days from liver resection	—

Measure

Time frame

Main Objective: To assess whether preoperatively initiated thromboprophylaxis prevents postoperative venous thromboembolism in patients undergoing liver surgery compared to postoperative initiated thromboprophylaxis;Secondary Objective: To assess bleeding and other postoperative complications;Primary end point(s): Venous thromboembolisms, number of patients, within 30 days from liver resection Venous thromboembolism is defined as either 1) symptomatic deep venous thromboembolism (includes all deep veins e.g. all extremities, portal vein, and superior mesenteric) diagnosed using ultrasound or computed tomography or magnetic resonance imaging, or in re-laparatomy/surgery, 2) pulmonary embolism diagnosed using computed tomography, magnetic resonance imaging, or lung perfusion imaging, or 3) death due to venous thromboembolism ;Timepoint(s) of evaluation of this end point: Within 30 days from liver resection

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Secondary

Measure	Time frame
Secondary end point(s): 1) Posthepatectomy haemorrhage, any grade in ISGLS classification, number of patients, within 30 days from liver resection 1) Comprehensive Complication Index – score, within 30 days from liver resection 2) Length of postoperative hospital stay, days 3) Total amount of transfused red blood cells, units, during and within 30 days from liver resection ;Timepoint(s) of evaluation of this end point: Within 30 days from liver resection	—

Measure

Time frame

Secondary end point(s): 1) Posthepatectomy haemorrhage, any grade in ISGLS classification, number of patients, within 30 days from liver resection 1) Comprehensive Complication Index – score, within 30 days from liver resection 2) Length of postoperative hospital stay, days 3) Total amount of transfused red blood cells, units, during and within 30 days from liver resection ;Timepoint(s) of evaluation of this end point: Within 30 days from liver resection

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Countries

Norway

Contacts

Public ContactTransplantation and Liver Surgery

Helsinki University Hospital

ville.sallinen@helsinki.fi35894711

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026