Bemiparin as a Thromboprophylaxis After Gynaecological Surgeries - Full Text View

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:

MedlinePlus related topics: Deep Vein Thrombosis

U.S. FDA Resources

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

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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 Cardiovascular Diseases Embolism Embolism and Thrombosis	Lung Diseases Respiratory Tract Diseases Vascular Diseases

ClinicalTrials.gov processed this record on February 27, 2015