Comparing effects of low dose heparin as intermittent SC injection and continuous IV infusion on the serum biomarkers of thrombosis in critically ill patients
The purpose of this study is comparing effects of different methods of heparin administration (intermittent SC injection and continuous IV infusion) on the serum biomarkers of thrombosis in critically ill patients. This study is a randomized, single-blind clinical trial. Forty six critically ill patients with indication for deep vein thrombosis prevention during ICU stay will be simply randomized in two equal groups. First group will be received SC heparin, 5000 IU three times a day for 7 days. The second group will be received heparin as continuous infusion with rate of 625 IU/hr for 7 days. Patients who need DVT or pulmonary emboli treatment, with heparin contraindications, autoimmune diseases, history of acute myocardial infarction and requiring dialysis will be excluded. Serum levels of the thrombosis biomarkers including P-selectin, Interleukin-10 and hs-CRP (C-reactive protein) will be measured at admission time and then days 3 and 7 in the included patients. Finally changes in the serum thrombosis biomarkers will be compared between the groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201402113449N14
Registration date:2014-03-13, 1392/12/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-03-13, 1392/12/22
Registrant information
Name
Hossein Khalili
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 4715
Email address
khalilih@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-02-15, 1392/11/26
Expected recruitment end date
2016-02-15, 1394/11/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing effects of low dose heparin as intermittent SC injection and continuous IV infusion on the serum biomarkers of thrombosis in critically ill patients
Public title
Heparin and deep vein thrombosis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Critically ill patients with age between 18-65 years old who will be admitted to ICU and have indication for deep vein thrombosis (DVT) prophylaxis
Exclusion criteria:
Patients who need DVT or pulmonary emboli treatment, have heparin contraindications, autoimmune diseases, history of acute myocardial infarction in last 21 days, and dialysis.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Method of randomization: Based on the random number table
Method of blinding: Patients and responsible person for data analysis will be blinded regarding type of intervention
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Ghods Ave.
City
Tehran
Postal code
Approval date
2014-02-16, 1392/11/27
Ethics committee reference number
93-01-33-25173
Health conditions studied
1
Description of health condition studied
Deep vein throbmosis
ICD-10 code
I82
ICD-10 code description
Formation of thrombosis in the deep veins
Primary outcomes
1
Description
Incidence of deep vein thrombosis
Timepoint
Daily up to 7 days
Method of measurement
Clinical assessment
Secondary outcomes
1
Description
Interleukin-10 serum level
Timepoint
Days 0,3,7
Method of measurement
Elisa kit
2
Description
P-selectin serum level
Timepoint
Days 0,3,7
Method of measurement
Elisa kit
3
Description
hs-CRP serum level
Timepoint
Days 0,3,7
Method of measurement
Elisa kit
Intervention groups
1
Description
Subcutaneous (SC) heparin as 5000 IU TDS
Category
Treatment - Drugs
2
Description
Intravenous continuous infusion of heparin as 625 IU/hr
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Hossein Khalili
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Tehran University of Medical Sciences
Full name of responsible person
Masoud Yunesian
Street address
Ghods Ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Khalili
Position
Pharm. D
Other areas of specialty/work
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 6695 4715
Fax
Email
khalilih@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran university of Medical Sciences
Full name of responsible person
Mandana Izadpanah
Position
Pharm. D
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
mandana.i@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)