Overview
Sponsor-declared trial summary
Liver surgery
Perioperatively initiated thromboprophylaxis reduces venous thromoboembolism without increasing the risk of bleeding complications.
Key facts
- Sponsor
- Oslo University Hospital HF
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 17 Mar 2022 → ongoing
- Decision date (initial)
- 2024-12-19
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-519726-20-00
- EudraCT number
- 2019-002323-15
- ClinicalTrials.gov
- NCT04731558
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis
Perioperatively initiated thromboprophylaxis reduces venous thromoboembolism without increasing the risk of bleeding complications.
Conditions and MedDRA coding
Liver surgery
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- All patients undergoing liver resection
Exclusion criteria 1
- Patient on anti-coagulative 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).
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Venous thromboembolisms, number of patients, within 30 days from liver resection.
Secondary endpoints 1
- 1) Posthepatectomy haemorrhage, any grade in ISGLS classification, number of patients, within 30 days from liver resection 2) Comprehensive Complication Index – score, within 30 days from liver resection 3) Length of postoperative hospital stay, days 4) Total amount of transfused red blood cells, units, during and within 30 days from liver resection
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SCP118777247 · ATC
- Active substance
- Enoxaparin Sodium
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 1120 mg milligram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- B01AB05 — ENOXAPARIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP12518807 · ATC
- Active substance
- Dalteparin Sodium
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 5000 IU international unit(s)
- Max total dose
- 140000 IU international unit(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- B01AB04 — DALTEPARIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Oslo University Hospital HF
- Sponsor organisation
- Oslo University Hospital HF
- Address
- Taarnbygget, Kirkeveien 166 Kirkeveien 166
- City
- Oslo
- Postcode
- 0450
- Country
- Norway
Scientific contact point
- Organisation
- Oslo University Hospital HF
- Contact name
- Sheraz Yaqub
Public contact point
- Organisation
- Oslo University Hospital HF
- Contact name
- Sheraz Yaqub
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Norway | Ongoing, recruiting | 500 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Norway | 2022-03-17 | 2022-03-17 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-519726-20-00 | 1 |
| Recruitment arrangements (for publication) | Placeholder | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF | 1.1 |
| Summary of Product Characteristics (SmPC) (for publication) | Dalteparin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Enoxaparin | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-11 | Norway | Acceptable 2024-12-19
|
2024-12-19 |