Leiden Trial in Prevention of Post-Operative ThromboEmbolic Events

NCT02987946 | Completed

• 1 other identifier: NL56552.058.16
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Lower incidence of thromboembolic complications in patients with IPD + LMWH by adding IPD to usual care, established with systematic doppler/duplex evaluation in all patients at 5 +/- 2 days post surgery

  The primary goal of the current study is to investigate whether the combination of perioperative intermittent pneumatic compression and LMWH has a lower incidence of postoperative thrombo-embolic complications within a week after a high risk neurosurgical intervention in comparison to patients receiving merely LMWH prophylaxis. All patients will be subjected to doppler/duplex in the week after surgery. Follow up of all patients will be performed at 5 +/- 2 days after surgery, during admission time. At this time all patient will have a duplex ultrasound examination to assess the prevalence of a possible deep venous thrombosis. This period has been chosen in analogy with existing literature (appendix A). 9-15 For this examination patients have to be able stand upright. Therefore in some cases (e.g ICU patients) the interval will be longer, with a maximum of 20 days.

  1 week

Secondary Outcomes (5)

• prevalence of DVT measured by duplex/doppler routinely performed in the whole study population

  1 week

• Clinical signs of DVT i.e. swollen,painful and red leg or pulmonary embolism

  2 months

• Quality of life by EQ-5D

  2 mos after surgery

• Patient perceived recovery with Likert scale

  2 months

• Cost effectiveness with EQ-5D and estimated costs in cost diaries

  2 months

Study Arms (2)

Fraxiparine

ACTIVE COMPARATOR

Intervention: All patients receive Fraxiparine 2850 IE daily, starting preoperatively compatible with current practice. After randomization the patients in this arm will be subjected to fraxipareine 2850 IE daily. According to current guidelines in the LUMC the Fraxiparine dose is doubled to 5600 IE in patients with a weight above 100 kg.

Drug: Fraxiparine

IPD

EXPERIMENTAL

Intervention: IPD Device: After randomization the patients in this arm will be subjected to fraxiparine 2850 IE daily and intermittent pressure devices for at least 48 hours or until mobilization. The intermittent pressure device is a leg pump delivered by Converis(R).

Device: IPD Device delivered by Converis; Drug: Fraxiparine

Interventions

IPD Device delivered by Converis DEVICE

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

Also known as: IPD

IPD

Fraxiparine DRUG

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

Also known as: LMWH

Fraxiparine; IPD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Tumour surgery (spinal or intracranial);
• \>180 min estimated surgical intervention time;
• \>240 min time under anaesthesia;
• Spine trauma surgery;

You may not qualify if:

• Age under 18 years;
• Perioperative continuation of anti coagulant therapy indicated other than prophylactic LMWH;

Sponsors & Collaborators

• Leiden University Medical Center: lead
• Medtronic - MITG: collaborator

Study Sites (1)

Leiden University Medical Centre

Leiden, South Holland, 2300RC, Netherlands

Location

MeSH Terms

Conditions

Venous Thrombosis

Interventions

Nadroparin; Heparin, Low-Molecular-Weight

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Carmen Vleggeert-Lankamp, MD MSc PhD

  Leiden University Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD MSc PhD

Study Record Dates

• First Submitted: November 16, 2016
• First Posted: December 9, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2023
• Study Completion: September 1, 2024
• Last Updated: March 10, 2025

Record last verified: 2024-06

Locations

NL (1)