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A Comparative Study of Prophylactic Anticoagulation in Meningioma Surgery

NCT01941602 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 979

Last updated 2017-10-02

No results posted yet for this study

Summary

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.

Conditions

  • Meningioma

Interventions

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

PROCEDURE

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.

Sponsors & Collaborators

  • Norwegian University of Science and Technology

    collaborator OTHER

  • University Hospital of North Norway

    collaborator OTHER

  • Karolinska University Hospital

    collaborator OTHER

  • St. Olavs Hospital

    lead OTHER

Principal Investigators

  • Lars Jacob Stovner, MD PhD · St. Olavs Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • Norway
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01941602 on ClinicalTrials.gov