A Comparative Study of Prophylactic Anticoagulation in Meningioma Surgery

St. Olavs Hospital

Status: Completed

Conditions: Meningioma

Treatments: Drug: prophylactic enoxaparin; Procedure: non-prophylactic

Study type: Observational

Funder types: Other

Identifiers

NCT01941602

2013/884

Details and patient eligibility

About

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.

Enrollment: 979 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

979 participants in 2 patient groups

prophylactic

Description:

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

Treatment:

Drug: prophylactic enoxaparin

non-prophylactic

Description:

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)

Treatment:

Procedure: non-prophylactic