NCT01941602

A Comparative Study of Prophylactic Anticoagulation in Meningioma Surgery

A Comparative Study of Prophylactic Enoxaparin Routinely Administered Preoperative for Prevention of Venous Thromboembolism in Meningioma Surgery - an Acceptable Risk-benefit Ratio?

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 979 (actual)
• Sponsor: St. Olavs Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Meningioma

Interventions

Type	Name	Description
DRUG	prophylactic enoxaparin	enoxaparin had been prescribed at a dose of 40 mg (once daily) from the evening before surgery until patients were well mobilized. Also, at the time of surgery compression stockings were used, as well as a sequential compression device (SCD) until the morning after or longer if mobilization was delayed
PROCEDURE	non-prophylactic	no pharmacological prophylaxis for venous thromboembolism (VTE) had been used routinely. Occasionally, with delayed mobilization, a low-dose low molecular weight heparin (LMWH) had been prescribed. SCD had been used at increased frequency, and is today considered routine.

Timeline

• Start date: 2013-08-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2013-09-13
• Last updated: 2017-10-02

Locations

3 sites across 2 countries: Norway, Sweden