Bemiparin as a Thromboprophylaxis After Gynaecological Surgeries

Pulmonary Embolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01630148
• Other study ID #: HMU
• Status: Completed
• Phase: N/A
• First received: June 26, 2012
• Last updated: October 3, 2014
• Start date: July 2012
• Est. completion date: March 2014

Study information

• Verified date: October 2014
• Source: Hawler Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: North of Iraq, Kurdistan region:Hawler Directorate of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 774
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Deep Vein Thrombosis (DVT)
• Pulmonary Embolism
• Venous Thrombosis

Intervention

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.

Locations

Country	Name	City	State
Iraq	Hawler medical university	Erbil city	Kurdistan region

Sponsors (1)

Lead Sponsor	Collaborator
Hawler Medical University

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes