Protocol summary

Summary
This Study Is A Clinical Trial Study In The Radiology Department Of Afzalipour Kerman Hospital In 1396_97. This Study Has Done on Women Who Require Hysterectomy Aged under 60. People At High Risk Of Deep Vein Thrombosis Include Those With Major Surgery. Hysterectomy Cases Due To Malignancy Or Patients with Aspirin Making, With Pelvic Trauma And Diabetes, Pulmonary And Heart Failure, History Of Previous Thrombosis And Long-Term Admission And Obese Patients (More Than 20% Of the Ideal Weight) Are Excluded. Sampling In This Study Will Be Facilitated By Sampling. The Sample Size Of The Study Was Based on Cases Of Hysterectomy In Women. For Each Group, 20 Persons (80 People Were Considered For More Certainty) Were Considered. Patients Are Randomly Divided Into Four Groups: Heparin Prophylaxis, Heparin Plus Compressive Socks, Prophylaxis With Enoxaparin And Enoxaparin Plus Compressive Socks. The First Group Of Patients Will Receive 5,000 Units Of SubCutaneous Heparin Prophylaxis Every 12 Hours For Three Days. In The Second Group, In Addition To Receiving 5,000 Units Of Heparin Units Every 12 Hours, The Compressive Socks Are Also Used. The Third Group Is Under Enoxaparin Prophylaxis 40 mg Daily For SubCutaneous Injection For Three Days And In The Last Group, Besides Enoxaparin 40 mg Daily, SubCutaneously, A Compressive Sock Is Also Used. Two Weeks After The Completion Of The Drug And Mechanical Prophylaxis Of Patients, The Doppler Ultrasound Radiologist Assistant Will Receive the Doppler Sonography Findings In A Checklist (Presence Or Absence Of Thrombosis).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017080935594N1
Registration date: 2017-09-28, 1396/07/06
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-09-28, 1396/07/06
Registrant information
Name
Ahmad Enhesari
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 32112563
Email address
enhesari@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman University of Medical Sciences
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison Of Efficacy Compressive Stocking With Heparin And Enoxaparin In Prevention Of Deep Vein Thrombosis Of Lower Extremities In Hysterectomized Patients
Public title
Comparison Of Efficacy Compressive Stocking With Heparin And Enoxaparin In Prevention Of Deep Vein Thrombosis Of Lower Extremities In Hysterectomized Patients
Purpose
Prevention
Inclusion/Exclusion criteria
Entry Criteria: Women In Need Of Hysterectomy; Under 60 Years Of Age. Exit Criteria: Hysterectomy Due To Malignancy; Patients With Aspirin Use; History Of Pelvic Trauma; Diabetes; Pulmonary And Heart Failure; History Of Previous Thrombosis And Long-Term Admission; Obese Patients (More Than 20% Of The Ideal Weight).
Age
To 60 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
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
Kerman University of Medical Sciences and Health Services
Street address
Kerman University of Medical Sciences, Afzalipour Pardis, Early axis of seven Alavi Gardens, Kerman, Iran
City
Kerman
Postal code
7916913555
Approval date
2017-08-10, 1396/05/19
Ethics committee reference number
1396.1269R.KMU.REC.

Health conditions studied

1

Description of health condition studied
lower limb vein thrombosis
ICD-10 code
180.3
ICD-10 code description
Phlebitis and thrombophlebitis of lower extremities, unspecified Embolism or thrombosis of lower extremity NOS

Primary outcomes

1

Description
The presence or absence of thrombosis
Timepoint
two weeks
Method of measurement
Based on the Doppler ultrasonography of the deep veins of the lower limb

Secondary outcomes

empty

Intervention groups

1

Description
Group 1 intervention: Prophylaxis with heparin subcutaneously 5,000 units every 12 hours for three days plus compressive socks Second group intervention: Prophylaxis with subcutaneous enoxaparin 40 mg daily for three days plus compressive socks
Category
Prevention

2

Description
Group 1 Control: Prophylaxis with subcutaneous heparin 5,000 units every 12 hours for 3 days Group 2 Control: Prophylaxis with subcutaneous enoxaparin 40 mg daily for three days
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Radiology Afzalipour Medical Education Center
Full name of responsible person
Ahmad Enhesri
Street address
Afzalipour Medical Education Center, Afzalipour Pardis, Imam Highway, Kerman, Iran
City
Kerman

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhti
Street address
Kerman University of Medical Sciences, Afzalipour Pardis, Early axis of seven Alavi Gardens, Kerman, Iran
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Ahmad Enhesari
Position
Professor of Radiology
Other areas of specialty/work
Street address
Kerman University of Medical Sciences, Afzalipour Pardis, Early axis of seven Alavi Gardens, Kerman, Iran
City
Kerman
Postal code
7916913555
Phone
+98 34 3132 5700
Fax
+98 31325605
Email
Enhesari@Kmu.ac.ir
Web page address
http://www.kmu.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Ahmad Enhesari
Position
Radiologist
Other areas of specialty/work
Street address
Kerman University of Medical Sciences, Afzalipour Pardis, Early axis of seven Alavi Gardens, Kerman, Iran
City
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Fax
+98 31325605
Email
Enhesari@Kmu.ac.ir
Web page address
www.Kmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kerman, University of Medical Sciences
Full name of responsible person
Ahmad Enhesari
Position
Radiologist
Other areas of specialty/work
Street address
Kerman University of Medical Sciences, Afzalipour Pardis, Early axis of seven Alavi Gardens, Kerman, Iran
City
Kerman
Postal code
7916913555
Phone
+98 34 3132 5700
Fax
+98 31325605
Email
Enhesari@kmu.ac.ir
Web page address
www.Kmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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