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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

Tracking Information
First Submitted Date  ICMJE June 26, 2012
First Posted Date  ICMJE June 28, 2012
Last Update Posted Date October 6, 2014
Study Start Date  ICMJE July 2012
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2012)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2012)
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,
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bemiparin as a Thromboprophylaxis After Gynaecological Surgeries
Official Title  ICMJE Bemiparin as a Thromboprophylaxis After Benign Gynaecological Surgeries:A Randomized Clinical Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE
  • Deep Vein Thrombosis (DVT)
  • Pulmonary Embolism
Intervention  ICMJE 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
Study Arms  ICMJE
  • Active Comparator: Bemiparin
    group one will be women who are risky for venous thromboembolic diseases after benign gynaecological surgeries, each will receive Bemiparin
    Intervention: Drug: Bemiparin
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 27, 2012)
774
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 15 Years to 90 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iraq
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01630148
Other Study ID Numbers  ICMJE HMU
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistant Prof. Shahla Alalaf, Hawler Medical University
Study Sponsor  ICMJE Hawler Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Hawler Medical University
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP