Objectives: Craniotomy because of post operative immobility is a risk factor for venous thrombosis. The aim of the present study was to compare the effect of tow routine prophylactic treatment; unfractionated heparin and low-molecular-weight heparin (clexane) in preventing DVT in patients with Brain tumor undergoing elective craniotomy. Design and setting: 154 Patients candidate for elective craniotomy due to brain tumor were enrolled in this randomized, double – blinded, controlled clinical trial from 2009 to 2010 in Isfahan IRAN. Patients were divided two groups after craniotomy. Participant including major eligibility criteria: Patients candidate for elective craniotomy due to brain tumor were enrolled in this study. Exclusion criteria: Patients with bleeding into the primary lesion; history of thrombotic events in the post 6 moths; or recent anticoagulation use were excluded. Patients that due to Paresis or plegia weren't ambulated even though treatment continued excluded from our study. Intervention: After 48 hour of craniotomy for first group Noxprin 40mg (Enoxaparin) made by Alborz Darou Co. daily and subcutaneously and for second group Heparodic (Heparin sulfate) made by Caspian Tamin Co. 5000 IU/12h was used. Main outcome measures: IN both groups Deep Vein Thrombosis as main outcome of both drugs efficacy was evaluated by physical examination and questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012102711274N1
Registration date:2013-06-08, 1392/03/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-06-08, 1392/03/18
Registrant information
Name
Nourallah Eshraghi
Name of organization / entity
Isfahan Medical University
Country
Iran (Islamic Republic of)
Phone
+98 31 1250 2664
Email address
n_eshraghi@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Drug's price was paid by authors from academic accounts supported by Vice Chancellor for research, University of Medical Science
Expected recruitment start date
2008-07-22, 1387/05/01
Expected recruitment end date
2011-01-20, 1389/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy Comparison of Unfractionated Heparin and Low Molecular Weight Heparin(LMWH) in Deep Vein Thrombosis Prophylaxis for Brain Tumor craniotomy
Public title
Comparison of Heparin and Clexane in Thrombosis Prevention after Craniotomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria : Patients candidate for elective craniotomy due to brain tumor were enrolled in this randomized, double – blinded, controlled clinical trial from 2009 to 2010 in Isfahan IRAN.
exclusion criteria : Patients with bleeding into the primary lesion; history of thrombotic events in the post 6 moths; or recent anticoagulation use were excluded.
Patients that due to Paresis or plegia weren't ambulated even though treatment continued, excluded from our study.
Age
From 36 years old to 62 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
154
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan Medical University
Street address
Hezar jerib ave, Isfahan Mededical University
City
Isfahan
Postal code
Approval date
2007-07-08, 1386/04/17
Ethics committee reference number
386302
Health conditions studied
1
Description of health condition studied
Deep Vein Thrombosis
ICD-10 code
I 80.2
ICD-10 code description
Phlebitis and Thrombophlebitis of other Deep Vessels of Lower Extremities
Primary outcomes
1
Description
Deep Vein Thrombosis
Timepoint
Before intervention , After intervention daily (from 48 h after operation) until 7 days
Method of measurement
1)Questionnaire, 2)Physical Examination 3) if any doubt remained Doppler Sonography was used
Secondary outcomes
1
Description
Blood Hypertention
Timepoint
Daily Physical Exams
Method of measurement
Daily physical exam
2
Description
Smoking history
Timepoint
Before intervention
Method of measurement
Questionnaire
3
Description
Diabetes Mellitus
Timepoint
Daily Physical Exams
Method of measurement
Lab Data
4
Description
Trombocytopenia
Timepoint
Daily
Method of measurement
Lab Data
Intervention groups
1
Description
intervention group: patients received subcutaneous clexane (40mg/d) 48 hours after craniotomy (Noxparin 40 made by Alborz Darou).
treatment continues until patients become mobile or maximum one week.
Category
Treatment - Drugs
2
Description
control group: patients received subcutaneous unfractionated heparin (5000 Iu/12h) Heparodic 5000 made by Caspian Tamin Pharmaceutical Co. 48 hours after craniotomy, treatment continues until patients become mobile or maximum one week.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Azahra Hospital
Full name of responsible person
Dr. Bahram Aminmansour;Associate Professor of Neurosurgery