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Completed

NCT Number: NCT01941602

A Comparative Study of Prophylactic Anticoagulation in Meningioma Surgery

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.

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Key information

Conditions

Meningioma Cardiovascular Diseases Central Nervous System Neoplasms Embolism and Thrombosis Meningeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Nerve Tissue Neoplasms, Vascular Tissue Nervous System Diseases Nervous System Neoplasms Thromboembolism Vascular Diseases Venous Thromboembolism

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of North Norway, Tromsø, Norway

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

prophylactic enoxaparin

Drug

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

Procedure

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.

Primary outcomes

  1. frequencies of venous thromboembolism

    Time frame: 30 days

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Collaborators

  • Karolinska University Hospital
  • Norwegian University of Science and Technology
  • University Hospital of North Norway

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 13, 2013
Registry last updated
Oct 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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