A Comparative Study of Prophylactic Anticoagulation in Meningioma Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Norwegian University of Science and Technology
University Hospital of North Norway
Karolinska University Hospital
Information provided by (Responsible Party):
St. Olavs Hospital
ClinicalTrials.gov Identifier:
NCT01941602
First received: September 2, 2013
Last updated: July 3, 2014
Last verified: July 2014
  Purpose

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 Intervention
Meningioma
Drug: prophylactic enoxaparin
Procedure: non-prophylactic

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: A Comparative Study of Prophylactic Enoxaparin Routinely Administered Preoperative for Prevention of Venous Thromboembolism in Meningioma Surgery - an Acceptable Risk-benefit Ratio?

Resource links provided by NLM:


Further study details as provided by St. Olavs Hospital:

Primary Outcome Measures:
  • frequencies of venous thromboembolism [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • frequencies of hematomas in need of reoperation or that significantly alters subsequent care [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 650
Study Start Date: August 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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
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)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients having had surgical treatment for intracranial meningioma in Norway (St Olavs University Hospital, Trondheim, and University Hospital North Norway, Tromsø) and Sweden (Karolinska University Hospital, Stockholm).

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01941602

Locations
Norway
University Hospital of North Norway
Tromsø, Norway
St Olavs Hospital
Trondheim, Norway
Sweden
Karolinska University Hospital
Stockholm, Sweden
Sponsors and Collaborators
St. Olavs Hospital
Norwegian University of Science and Technology
University Hospital of North Norway
Karolinska University Hospital
Investigators
Principal Investigator: Asgeir S Jakola, MD PhD St. Olavs Hospital
  More Information

No publications provided

Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT01941602     History of Changes
Other Study ID Numbers: 2013/884
Study First Received: September 2, 2013
Last Updated: July 3, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by St. Olavs Hospital:
surgery
enoxaparin
venous thromboembolism
perioperative care

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

ClinicalTrials.gov processed this record on September 18, 2014