Comparison of intravenous enoxaparin with subcutaneous enoxaparin in preventing venous thromboembolism in patients admitted to the intensive care unit
Design
This randomized clinical trial was performed on 20 patients in the intensive care unit. The patients were selected according to inclusion criteria and then randomly by using the draw. divided into groups receiving subcutaneous and intravenous enoxaparin.
Settings and conduct
The present randomized clinical trial was performed after approval by the Deputy of Research and Technology of Zahedan University of Medical Sciences and informed consent from legal guardians of the ICU patients admitted at Khatam-Al-Anbia Hospital in Zahedan (Iran).
Participants/Inclusion and exclusion criteria
Inclusion criteria were the age range of 18 -70 years, hospitalization for at least 48 hours in ICU, mechanical ventilation, normal renal and hepatic function, Exclusion Criteria: history of deep vein thrombosis and pulmonary embolism, history of coagulation disorders, treated with other anticoagulants before hospitalization, prosthetic implantation, myelodysplastic syndrome, and other blood dyscrasias, passing 48 hours from surgery in patients with intracerebral hemorrhage.
Intervention groups
Patients were divided into two groups: subcutaneous enoxaparin and intravenous enoxaparin. Subsequently, 2cc of the blood sample was taken of the patients in the two groups to measure the active factor Xa level. In the first group, 0.5 mg/kg of enoxaparin was injected subcutaneously. In the second group, the same dose of enoxaparin was injected slowly through a peripheral vein. Repeated blood sampling was done for measuring the factor level 4 hours after the first injection and 12 hours after the last injection on day 10, both groups were retested and the active factor Xa level was measured again.
Main outcome variables
Measure the active factor Xa level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191012045075N1
Registration date:2020-01-26, 1398/11/06
Registration timing:retrospective
Last update:2020-01-26, 1398/11/06
Update count:0
Registration date
2020-01-26, 1398/11/06
Registrant information
Name
masoum khoshfetrat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3324 5654
Email address
khoshfetrat@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2013-10-22, 1392/07/30
Actual recruitment start date
2013-09-23, 1392/07/01
Actual recruitment end date
2013-11-01, 1392/08/10
Trial completion date
2013-11-01, 1392/08/10
Scientific title
Comparison of intravenous enoxaparin with subcutaneous enoxaparin in preventing venous thromboembolism in patients admitted to intensive care unit
Public title
Comparison of intravenous enoxaparin with subcutaneous enoxaparin in preventing venous thromboembolism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ages 18 to 70 years
Hospitalization for at least 48 hours in ICU
Mechanical ventilation
Normal renal and hepatic function
Passing 48 hours from surgery in patients with intracerebral hemorrhage (epidural , subdural and intracerebral hematoma and hemorrhagic stroke)
Exclusion criteria:
History of deep vein thrombosis
History of pulmonary embolism
History of coagulation disorders (hemophilia, disseminated intravascular coagulation, idiopathic thrombocytopenia, heparin- induced thrombocytopenia and disruption of coagulation tests)
Treated with other anticoagulants before hospitalization
Prosthetic implantation (artificial heart valve, stent and IVC filter)
Myelodysplastic syndrome and other blood dyscrasias
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
20
Actual sample size reached:
20
Randomization (investigator's opinion)
Randomized
Randomization description
The patients were selected by the convenience sampling method based on inclusion criteria, and then randomly divided into two groups. To ensure the randomization process, a total of 20 green and orange cards (corresponding to the estimated sample size) were prepared. A total of 10 green and 10 orange cards were assigned to each group, respectively the cards were arranged in the black box. After the patient having the inclusion criteria. A card was picked up from the box. And if the card was green, the patients assigned to the group I (subcutaneous enoxaparin). And if it was orange the patients assigned to group II(intravenous enoxaparin).
Blinding (investigator's opinion)
Single blinded
Blinding description
Laboratory personnel who measured the patient's blood factor levels were unaware of the patients' placement in the study groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Campus of Medical Sciences, Dr. Hassabi Square., University Ave., Zahedan Town
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9861715799
Approval date
2013-07-28, 1392/05/06
Ethics committee reference number
IR.ZAUMS.REC.1392.6030
Health conditions studied
1
Description of health condition studied
Intravenous thromboembolism
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Active factor Xa level
Timepoint
At baseline, 4 hours after the first injection, day 10 of the study 12 hours after the last injection
Method of measurement
The measurement of active factor levels was followed up by the laboratory without the researchers' knowledge of how the test was performed.
Secondary outcomes
empty
Intervention groups
1
Description
In the first group, 0.5 mg/kg of enoxaparin (AVENTIS PHARMA Co., France) was injected subcutaneously in the deltoid region and rotationally the internal surface of the groin on both sides of the body.
Category
Treatment - Drugs
2
Description
In the second group, 0.5 mg/kg of enoxaparin (AVENTIS PHARMA Co., France) was injected slowly through a peripheral vein.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam alanbia hospital
Full name of responsible person
Masoum khoshfetrat
Street address
Jame Jam Ave,
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9861715799
Phone
+98 54 3398 5245
Email
khatam@domian.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mohsen taheri
Street address
University of Medical Sciences, Dr. Hasabi Square, University Street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9861715799
Phone
+98 54 3358 7484
Email
Taheri@zaums.ac.ir
Grant name
Research budget
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Masoum khoshfetrat
Position
Associated Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Zahedan, Jame jam ave, khatam alanbia hospital
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9861715799
Phone
+98 915 349 0213
Email
khoshfetrat@zaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Masoum Khoshfetrat
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Jame jam Ave,
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3322 0501
Email
drkhoshfetrat@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Masoum Khoshfetrat
Position
Associated professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Zahedan, Jamejam Ave, Khatam alnbia Hospital
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
054332230013
Email
Drkhoshfetrat@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD