A Comparative Study of Prophylactic Anticoagulation in Meningioma Surgery

Completed

• Conditions: Meningioma
• Interventions: Drug: prophylactic enoxaparin; Procedure: non-prophylactic

• Registration Number: NCT01941602
• Lead Sponsor: St. Olavs Hospital

Brief Summary

The aim of the study is to compare different strategies for prevention of venous thromboembolism related to intracranial meningioma surgery. The investigators identified three hospitals where two have a very restrictive approach with respect to anticoagulant therapy while at the third hospital the use of anticoagulation the day before surgery was initiated as routine prophylaxis.

Based on this "natural experiment" it will be explored whether the use of anticoagulant prophylaxis is associated with reduced risk of venous thromboembolism and/or associated with increased risk of postoperative hemorrhage as compared to the 2 cohorts where this intervention were absent.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-09-02
• Study First Submitted QC: 2013-09-09
• Study First Posted: 2013-09-13
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-28
• Last Update Posted: 2017-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 979

Inclusion Criteria

• First included patient 1.january 2007 and latest included patient 1.july 2013 (allows for 30 day follow up with respect to morbidity)
• Histological verification of a meningioma (of any grade) from the current surgery

Exclusion Criteria

• Intracranial surgery or venous thromboembolism the last 3 months

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
prophylactic	prophylactic enoxaparin	Prophylactic treatment with drugs to prevent venous thromboembolism in patients operated with open surgery for intracranial meningioma at the Department of neurosurgery at Karolinska Hospital, Stockholm, Sweden
non-prophylactic	non-prophylactic	No use of prophylactic treatment with drugs to prevent venous thromboembolism in patients operated with open surgery for intracranial meningioma at the Departments of neurosurgery at University Hospital North Norway (UNN) and St.Olavs University Hospital (Tromsø and Trondheim respectively, both Norway)

Primary Outcome Measures

Name	Time	Method
frequencies of venous thromboembolism	30 days

Secondary Outcome Measures

Name	Time	Method
frequencies of hematomas in need of reoperation or that significantly alters subsequent care	30 days	frequencies of hematomas in need of reoperation or that significantly alters subsequent care (e.g. intensive care unit or other intensified treatment based on postoperative intracranial hemorrhage)

Trial Locations

Locations (3)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden

University Hospital of North Norway; 🇳🇴 Tromsø, Norway

St Olavs Hospital; 🇳🇴 Trondheim, Norway