A Comparative Study of Prophylactic Anticoagulation in Meningioma Surgery
NCT ID: NCT01941602
Last Updated: 2017-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
979 participants
OBSERVATIONAL
2013-08-31
2015-10-31
Brief Summary
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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
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Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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prophylactic
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
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
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)
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.
Interventions
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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
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.
Eligibility Criteria
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Inclusion Criteria
* Histological verification of a meningioma (of any grade) from the current surgery
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Norwegian University of Science and Technology
OTHER
University Hospital of North Norway
OTHER
Karolinska University Hospital
OTHER
St. Olavs Hospital
OTHER
Responsible Party
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Principal Investigators
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Lars Jacob Stovner, MD PhD
Role: STUDY_DIRECTOR
St. Olavs Hospital
Locations
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University Hospital of North Norway
Tromsø, , Norway
St Olavs Hospital
Trondheim, , Norway
Karolinska University Hospital
Stockholm, , Sweden
Countries
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References
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Sjavik K, Bartek J Jr, Solheim O, Ingebrigtsen T, Gulati S, Sagberg LM, Forander P, Jakola AS. Venous Thromboembolism Prophylaxis in Meningioma Surgery: A Population-Based Comparative Effectiveness Study of Routine Mechanical Prophylaxis with or without Preoperative Low-Molecular-Weight Heparin. World Neurosurg. 2016 Apr;88:320-326. doi: 10.1016/j.wneu.2015.12.077. Epub 2015 Dec 31.
Other Identifiers
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2013/884
Identifier Type: -
Identifier Source: org_study_id