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Bemiparin as a Thromboprophylaxis After Gynaecological Surgeries

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ClinicalTrials.gov Identifier: NCT01630148
Recruitment Status : Completed
First Posted : June 28, 2012
Last Update Posted : October 6, 2014
Sponsor:
Information provided by (Responsible Party):
Assistant Prof. Shahla Alalaf, Hawler Medical University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Deep Vein Thrombosis (DVT) Pulmonary Embolism Drug: Bemiparin Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 774 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Bemiparin as a Thromboprophylaxis After Benign Gynaecological Surgeries:A Randomized Clinical Trial
Study Start Date : July 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Bemiparin
group one will be women who are risky for venous thromboembolic diseases after benign gynaecological surgeries, each will receive Bemiparin
 Drug: Bemiparin
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.
Other Name: Hibor; Laboratories Rovi pharmaceuticals
No Intervention: control group
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.


Outcome Measures
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Primary Outcome Measures :
  1. Evidences of clinical thromboembolic disease after gynaecological surgeries [ Time Frame: within the first 30 days after surgery the first 30 days ]
    to determine the efficacy of the new second generation LMWH in prevention Deep vein thrombosis and pulmonary embolism after gynaecological surgeries


Secondary Outcome Measures :
  1. to determine the side effects of Bemiparin injection [ Time Frame: after receiving the injections and up to 30 days after surgery ]
    To determine the safety of Bemiparin after gynaecological surgeries including bruising or pain at site of injection,itching,allergic skin reactions,urticaria, bleeding,


Eligibility Criteria
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Ages Eligible for Study:   15 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01630148


Locations
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Iraq
Hawler medical university
Erbil city, Kurdistan region, Iraq, 383-65
Sponsors and Collaborators
Hawler Medical University
Investigators
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Principal Investigator: Shahla K. Alalaf, M.D Hawler Medical University
Study Chair: Ariana K. Jawad, C.A.B.OG Hawler Ministry of Health
Study Chair: Rojan K. Jawad, Diploma Hawler Medical University
Study Chair: Mahabad S. Ali, Diploma Hawler Ministry of Health
Study Director: Namir G. Al Tawil, Professor Hawler Medical University
More Information
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Responsible Party: Assistant Prof. Shahla Alalaf, Assistant Professor, Hawler Medical University
ClinicalTrials.gov Identifier: NCT01630148    
Other Study ID Numbers: HMU
First Posted: June 28, 2012    Key Record Dates
Last Update Posted: October 6, 2014
Last Verified: October 2014
Keywords provided by Assistant Prof. Shahla Alalaf, Hawler Medical University:
Thromboprophylaxis
Bemiparin
Low Molecular Weight Heparin
Major Gynaecological Surgeries
Benign Gynaecological Surgeries
Additional relevant MeSH terms:
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Pulmonary Embolism
Thrombosis
Embolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
 Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Bemiparin
Anticoagulants