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Bemiparin as a Thromboprophylaxis After Gynaecological Surgeries

Primary Purpose

Deep Vein Thrombosis (DVT), Pulmonary Embolism

Status
Completed
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
Bemiparin
Sponsored by
Hawler Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Deep Vein Thrombosis (DVT) focused on measuring Thromboprophylaxis, Bemiparin, Low Molecular Weight Heparin, Major Gynaecological Surgeries, Benign Gynaecological Surgeries

Eligibility Criteria

15 Years - 90 Years (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • female undergoing Benign gynecological surgeries.
  • Having moderate,high and very high risk factors for venous thromboembolism.
  • No contraindications for the use of Heparin.

Exclusion Criteria:

  • Having mild risk factors for thromboembolism.
  • Active vaginal bleeding.
  • Thrombocytopaenia.
  • any patient who is already on anticoagulant.
  • Sever renal or Liver diseases.

Sites / Locations

  • Hawler medical university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Bemiparin

control group

Arm Description

group one will be women who are risky for venous thromboembolic diseases after benign gynaecological surgeries, each will receive Bemiparin

women will undergo benign gynaecological surgeries and are risky for venous thrombosis, they will not receive any intervention. The patients will be followed up to 30 days after surgery.

Outcomes

Primary Outcome Measures

Evidences of clinical thromboembolic disease after gynaecological surgeries
to determine the efficacy of the new second generation LMWH in prevention Deep vein thrombosis and pulmonary embolism after gynaecological surgeries

Secondary Outcome Measures

to determine the side effects of Bemiparin injection
To determine the safety of Bemiparin after gynaecological surgeries including bruising or pain at site of injection,itching,allergic skin reactions,urticaria, bleeding,

Full Information

First Posted
June 26, 2012
Last Updated
October 3, 2014
Sponsor
Hawler Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01630148
Brief Title
Bemiparin as a Thromboprophylaxis After Gynaecological Surgeries
Official Title
Bemiparin as a Thromboprophylaxis After Benign Gynaecological Surgeries:A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hawler Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The use of prophylaxis for venous thromboembolism (VTE) remains grossly underused for women who undergo gynecologic surgery for benign conditions world wide and especially in developing countries including our region. Having a research in our locality for the first time might raise awareness of the importance of VTE prophylaxis.
Detailed Description
Deep vein thrombosis (DVT) and pulmonary embolism (PE), also referred to as venous thromboembolic events (VTE), are two major complications after gynaecological surgeries that can result in significant morbidity and mortality. The incidence of VTE after gynaecologic surgery varies depending on the method used for diagnosis. The rate of clinical DVT is estimated to be 3% after gynaecological surgery if no thromboprophylaxis was used. The rate of VTE assumed to decrease to 0.4% if Low molecular weight heparin was used as a thromboprophylaxis. According to our knowledge there are no published researches on the effect of the new second generation Low molecular Weight Heparin Bemiparin as a thromboprophylaxis after benign gynaecological surgery in comparison to a control group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Vein Thrombosis (DVT), Pulmonary Embolism
Keywords
Thromboprophylaxis, Bemiparin, Low Molecular Weight Heparin, Major Gynaecological Surgeries, Benign Gynaecological Surgeries

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
774 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bemiparin
Arm Type
Active Comparator
Arm Description
group one will be women who are risky for venous thromboembolic diseases after benign gynaecological surgeries, each will receive Bemiparin
Arm Title
control group
Arm Type
No Intervention
Arm Description
women will undergo benign gynaecological surgeries and are risky for venous thrombosis, they will not receive any intervention. The patients will be followed up to 30 days after surgery.
Intervention Type
Drug
Intervention Name(s)
Bemiparin
Other Intervention Name(s)
Hibor; Laboratories Rovi pharmaceuticals
Intervention Description
Bemiparin Sodium 3,500IU anti Xa/0.3 ml solution for injection in pre-filled syringe will be provided for each patient in Bemiparin group (Moderate, High and Highest risk groups for thromboembolism) 6 hours after surgery and then daily for up to 7 days.
Primary Outcome Measure Information:
Title
Evidences of clinical thromboembolic disease after gynaecological surgeries
Description
to determine the efficacy of the new second generation LMWH in prevention Deep vein thrombosis and pulmonary embolism after gynaecological surgeries
Time Frame
within the first 30 days after surgery the first 30 days
Secondary Outcome Measure Information:
Title
to determine the side effects of Bemiparin injection
Description
To determine the safety of Bemiparin after gynaecological surgeries including bruising or pain at site of injection,itching,allergic skin reactions,urticaria, bleeding,
Time Frame
after receiving the injections and up to 30 days after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: female undergoing Benign gynecological surgeries. Having moderate,high and very high risk factors for venous thromboembolism. No contraindications for the use of Heparin. Exclusion Criteria: Having mild risk factors for thromboembolism. Active vaginal bleeding. Thrombocytopaenia. any patient who is already on anticoagulant. Sever renal or Liver diseases.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shahla K. Alalaf, M.D
Organizational Affiliation
Hawler Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ariana K. Jawad, C.A.B.OG
Organizational Affiliation
Hawler Ministry of Health
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Rojan K. Jawad, Diploma
Organizational Affiliation
Hawler Medical University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mahabad S. Ali, Diploma
Organizational Affiliation
Hawler Ministry of Health
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Namir G. Al Tawil, Professor
Organizational Affiliation
Hawler Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Hawler medical university
City
Erbil city
State/Province
Kurdistan region
ZIP/Postal Code
383-65
Country
Iraq

12. IPD Sharing Statement

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Bemiparin as a Thromboprophylaxis After Gynaecological Surgeries

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