Bemiparin as a Thromboprophylaxis After Gynaecological Surgeries

Bemiparin as a Thromboprophylaxis After Benign Gynaecological Surgeries:A Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Embolism; Deep Vein Thrombosis (DVT)
• Intervention / Treatment: Drug: Bemiparin

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: Interventional
• Enrollment (Actual): 774
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iraq
  • Kurdistan region
    • Erbil city, Kurdistan region, Iraq, 383-65
      • Hawler Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 90 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	within the first 30 days after surgery the first 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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,	after receiving the injections and up to 30 days after surgery

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (ACTUAL): March 1, 2014
• Study Completion (ACTUAL): March 1, 2014

Study Registration Dates

• First Submitted: June 26, 2012
• First Submitted That Met QC Criteria: June 27, 2012
• First Posted (ESTIMATE): June 28, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): October 6, 2014
• Last Update Submitted That Met QC Criteria: October 3, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Bemiparin; Thromboprophylaxis; Low Molecular Weight Heparin; Major Gynaecological Surgeries; Benign Gynaecological Surgeries
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Thrombosis; Venous Thrombosis; Pulmonary Embolism; Anticoagulants; Bemiparin
• Other Study ID Numbers: HMU