A Comparative Study of Prophylactic Anticoagulation in Meningioma Surgery

Meningioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01941602
• Other study ID #: 2013/884
• Status: Completed
• Phase: N/A
• First received: September 2, 2013
• Last updated: September 28, 2017
• Start date: August 2013
• Est. completion date: October 2015

Study information

• Verified date: September 2017
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 979
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Meningioma
• Thromboembolism
• Venous Thromboembolism

Intervention

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.

Locations

Country	Name	City	State
Norway	University Hospital of North Norway	Tromsø
Norway	St Olavs Hospital	Trondheim
Sweden	Karolinska University Hospital	Stockholm

Sponsors (4)

Lead Sponsor	Collaborator
St. Olavs Hospital	Karolinska University Hospital, Norwegian University of Science and Technology, University Hospital of North Norway

Countries where clinical trial is conducted

Norway,  Sweden, 

References & Publications (1)

Sjåvik K, Bartek J Jr, Solheim O, Ingebrigtsen T, Gulati S, Sagberg LM, Förander P, Jakola AS. Venous Thromboembolism Prophylaxis in Meningioma Surgery: A Population-Based Comparative Effectiveness Study of Routine Mechanical Prophylaxis with or without P — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	frequencies of venous thromboembolism		30 days
Secondary	frequencies of hematomas in need of reoperation or that significantly alters subsequent care	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)	30 days