Risk of Thromboembolism in patients undergoing craniotomy with intraoperative application of intermittent pneumatic compression of the legs: A prospective, randomized, single-blinded multicenter study

Not Applicable

Not yet recruiting

• Conditions: Venous thromboembolism during craniotomy; I80.2; I26; Phlebitis and thrombophlebitis of other deep vessels of lower extremities; Pulmonary embolism

• Registration Number: DRKS00034190
• Lead Sponsor: Martin-Luther-Universität Halle-Wittenberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-02
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

Elective surgery for intracranial pathology via craniotomy

Exclusion Criteria

- Pregnancy
- patients incapable of giving consent
- Perioperative administration of blood products
- Abnormal coagulation (platelets and/or plasmatic coagulation, liver disease, use of antiplatelet agents)
- Contraindication to the use of IPC (dermatitis in the lower leg area, recent skin transplantation; severe arteriosclerosis or other ischemic vascular diseases, massive leg oedema or pulmonary oedema due to heart failure; extreme deformity of the leg)
pre-existing thromboembolism
Clinical signs of deep vein thrombosis
Preoperative D-dimer >0.5 µg/mlFE

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of (symptomatic and asymptomatic) VTE (yes/no) within 7 days post-op

Secondary Outcome Measures

Name	Time	Method
Occurrence of the following events within 7 days:<br>- Proximal and distal deep vein thrombosis (DVT)<br>- symptomatic VTE<br>- asymptomatic VTE<br>- Muscular vein thrombosis<br>- Thrombosis associated with a central venous catheter<br>- Pulmonary embolism<br>- death<br>- Influence of the type of lesion and the duration of the operation.