A Comparative Study of Prophylactic Anticoagulation in Meningioma Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01941602|
Recruitment Status : Completed
First Posted : September 13, 2013
Last Update Posted : October 2, 2017
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.
|Condition or disease||Intervention/treatment|
|Meningioma||Drug: prophylactic enoxaparin Procedure: non-prophylactic|
|Study Type :||Observational|
|Actual Enrollment :||979 participants|
|Official Title:||A Comparative Study of Prophylactic Enoxaparin Routinely Administered Preoperative for Prevention of Venous Thromboembolism in Meningioma Surgery - an Acceptable Risk-benefit Ratio?|
|Actual Study Start Date :||August 2013|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||October 2015|
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
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
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)
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.
- frequencies of venous thromboembolism [ Time Frame: 30 days ]
- frequencies of hematomas in need of reoperation or that significantly alters subsequent care [ Time Frame: 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01941602
|University Hospital of North Norway|
|St Olavs Hospital|
|Karolinska University Hospital|
|Study Director:||Lars Jacob Stovner, MD PhD||St. Olavs Hospital|