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Leiden Trial in Prevention of Post-Operative ThromboEmbolic Events

NCT02987946 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2025-03-10

No results posted yet for this study

Summary

In neurosurgical patients, the risk for venous thromboembolic events (VTE) is high due to the relatively long duration of surgery, the high occurrence of prolonged immobilization of patients due to paresis of the legs or intracranial pathology causing inability to mobilise2. Moreover, intracranial and intraspinal tumours and subarachnoid haemorrhage cause hypercoagulability, which increases the risk on VTE. There is a high degree of diversity in attributed risk on thrombosis in the neurosurgical patient cohort. Due to this diversity, insufficient power of performed studies and lack of careful phenotyping and description of risk factors in previous studies on deep venous thrombosis (DVT) prophylaxis, as yet the optimal DVT prophylaxis in neurosurgery remains unclear. A prospective randomized study with adequate power and detailed information on patient related factors (malignancy, subarachnoid haemorrhage, prevailing coagulopathies), type of surgery, duration of surgery, and postoperative immobilisation will allow us to identify the optimal treatment strategy for high risk neurosurgical patients.

In the current study all patients that fulfil the inclusion criteria will be subjected to post-operative systematic evaluation of VTE by echo-duplex investigation.

Conditions

  • Deep-Venous Thrombosis

Interventions

DEVICE

IPD Device delivered by Converis

After randomization patients will be subjected to perioperative (48 hrs) intermittent pneumatic compression.

DRUG

Fraxiparine

All patients receive Fraxiparine 2850 IE daily, starting preoperatively compatible with current practice.

Sponsors & Collaborators

  • Medtronic - MITG

    collaborator INDUSTRY

  • Leiden University Medical Center

    lead OTHER

Principal Investigators

  • Carmen Vleggeert-Lankamp, MD MSc PhD · Leiden University Medical Centre

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2023-12-31
Completion
2024-09-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02987946 on ClinicalTrials.gov