Evaluation of the effect of systemic anticoagulants on anastomotic blood flow after initial repair of arterial injuries in patients with penetrating upper limb arterial trauma
Design
Randomized clinical trial, with control group, with parallel groups, without blinding, phase 3 on 118 patients. Blocking method was used for randomization using Randomization.com online software.
Settings and conduct
A randomized clinical trial study without blindness that will be performed after approval by the ethics committee of Arak University of Medical Sciences in Valiasr Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age less than 30 years, upper extremity arterial injury requiring surgical repair. Exclusion criteria: Simultaneous injury to other parts of the body, concurrent nerve damage that causes sensory or motor disturbances on examination, underlying vascular disease
Intervention groups
Intervention group: Patients receive heparin during treatment (5000 units as intravenous bolus). They then receive intravenous infusion of heparin maintenance therapy (18 units per kilogram per hour) within 24 hours after surgery. Control group: Patients receive heparin during treatment (5000 units as intravenous bolus). They will then receive standard treatment.
Main outcome variables
Upper extremity blood supply
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190717044255N3
Registration date:2021-11-29, 1400/09/08
Registration timing:prospective
Last update:2021-11-29, 1400/09/08
Update count:0
Registration date
2021-11-29, 1400/09/08
Registrant information
Name
Ali Azizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3276 7500
Email address
a.azizi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-02-19, 1400/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of systemic anticoagulants on the out come of primary repairing arterial injuries due to penetrating trauma of the upper limb
Public title
The effect of systemic anticoagulants in repairing penetrating upper limb arterial trauma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age less than 30 years
Upper extremity vascular injury that requires surgical repair
Exclusion criteria:
Existence of multiple injuries in other parts of the body
Existence of nerve damage associated with impaired sensory and motor examination
Underlying vascular disorders
Age
From 18 years old to 30 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
116
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization in this study will be done using block randomization method. In this way, patients will be divided into 20 blocks of 6 by Randomization.com online software. Then, in order to hide 20 envelopes with aluminum wrappers (in order to obscure the contents of the envelopes), prepare and create each of random sequences. It is registered on a card and the cards are placed in the envelopes of the order, respectively. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes of the letter is opened in order and the assigned group of the participant is revealed.
Blinding (investigator's opinion)
Not 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 Arak University of Medical Sciences
Street address
Basij sq., Sardasht Town
City
Arak
Province
Markazi
Postal code
3848176341
Approval date
2021-10-25, 1400/08/03
Ethics committee reference number
IR.ARAKMU.REC.1400.191
Health conditions studied
1
Description of health condition studied
Arterial trauma
ICD-10 code
I23.6
ICD-10 code description
Primary outcomes
1
Description
Arterial blood supply
Timepoint
6 hours after surgery, 24 hours after surgery, at discharge, one week after discharge
Method of measurement
Based on clinical examination criteria for limb color, end pulses, sensation and movement, and capillary filling
Secondary outcomes
empty
Intervention groups
1
Description
Fifty-eight patients will receive a 5,000-unit intravenous heparin treatment during surgery (Chimidaro, Iran) and then receive standard anticoagulant therapy after surgery.
Category
Treatment - Drugs
2
Description
Intervention group: During surgery, 58 patients received 5,000 units of heparin (Chimidaro, Iran) intravenous bolus treatment for once. Then, within 24 hours after surgery, they receive heparin maintenance treatment (Chimidaro, Iran) at a rate of 18 units per kilogram per hour as an intravenous infusion.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Farshad Fereydoon Rajabi
Street address
Valiasr Sq.
City
Arak
Province
Markazi
Postal code
3814957588
Phone
+98 86 3222 2003
Email
pr_valieasr@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
Basij sq., Sardasht Town
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3639
Email
research@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Farshad Fereydoon Rajabi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Valiasr Hospital, Valiasr Sq.
City
Arak
Province
Markazi
Postal code
3814957558
Phone
00989632222003
Email
Farshadfereydo@gmil.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Farshad Fereydoon Rajabi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Valiasr Hospital, Valiasr Sq.
City
Arak
Province
Markazi
Postal code
3814957558
Phone
00989632222003
Email
Farshadfereydo@gmil.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Farshad Fereydoon Rajabi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Valiasr Hospital, Valiasr Sq.
City
Arak
Province
Markazi
Postal code
3814957558
Phone
00989632222003
Email
Farshadfereydo@gmil.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available