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Bemiparin as a Thromboprophylaxis After Gynaecological Surgeries

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistant Prof. Shahla Alalaf, Hawler Medical University
ClinicalTrials.gov Identifier:
NCT01630148
First received: June 26, 2012
Last updated: October 3, 2014
Last verified: October 2014
  Purpose

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 Intervention
Deep Vein Thrombosis (DVT)
Pulmonary Embolism
Drug: Bemiparin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Bemiparin as a Thromboprophylaxis After Benign Gynaecological Surgeries:A Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Hawler Medical University:

Primary Outcome Measures:
  • Evidences of clinical thromboembolic disease after gynaecological surgeries [ Time Frame: within the first 30 days after surgery the first 30 days ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: after receiving the injections and up to 30 days after surgery ] [ Designated as safety issue: Yes ]
    To determine the safety of Bemiparin after gynaecological surgeries including bruising or pain at site of injection,itching,allergic skin reactions,urticaria, bleeding,


Enrollment: 774
Study Start Date: July 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   15 Years to 90 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01630148

Locations
Iraq
Hawler medical university
Erbil city, Kurdistan region, Iraq, 383-65
Sponsors and Collaborators
Hawler Medical University
Investigators
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

No publications provided

Responsible Party: Assistant Prof. Shahla Alalaf, Assistant Professor, Hawler Medical University
ClinicalTrials.gov Identifier: NCT01630148     History of Changes
Other Study ID Numbers: HMU
Study First Received: June 26, 2012
Last Updated: October 3, 2014
Health Authority: North of Iraq, Kurdistan region:Hawler Directorate of Health

Keywords provided by Hawler Medical University:
Thromboprophylaxis
Bemiparin
Low Molecular Weight Heparin
Major Gynaecological Surgeries
Benign Gynaecological Surgeries

Additional relevant MeSH terms:
Pulmonary Embolism
Thrombosis
Venous Thrombosis
Cardiovascular Diseases
Embolism
Embolism and Thrombosis
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014