A Comparative Study of Prophylactic Anticoagulation in Meningioma Surgery

Study Overview
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Brief Summary
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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.

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

Conditions
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Meningioma

Intervention / Treatment
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* Drug: prophylactic enoxaparin
* Procedure: non-prophylactic


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| prophylactic<br>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 | Drug: prophylactic enoxaparin<br>* 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<br>|
| non-prophylactic<br>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) | Procedure: non-prophylactic<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequencies of venous thromboembolism |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequencies of hematomas in need of reoperation or that significantly alters subsequent care | 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) | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surgery, enoxaparin, venous thromboembolism, perioperative care