Bemiparin as a Thromboprophylaxis After Gynaecological Surgeries

NCT01630148 | Completed DMC

• 1 other identifier: HMU
• Study Type: interventional
• Target: 774
• Locations: 1 country
• Sites: 1

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.

Conditions

Deep Vein Thrombosis (DVT); Pulmonary Embolism

Keywords

Thromboprophylaxis; Bemiparin; Low Molecular Weight Heparin; Major Gynaecological Surgeries; Benign Gynaecological Surgeries

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• to determine the side effects of Bemiparin injection

  after receiving the injections and up to 30 days after surgery

Study Arms (2)

Bemiparin

ACTIVE COMPARATOR

group one will be women who are risky for venous thromboembolic diseases after benign gynaecological surgeries, each will receive Bemiparin

Drug: Bemiparin

control group

NO INTERVENTION

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.

Interventions

Bemiparin DRUG

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.

Also known as: Hibor; Laboratories Rovi pharmaceuticals

Bemiparin

Eligibility Criteria

• Age: 15 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• female undergoing Benign gynecological surgeries.
• Having moderate,high and very high risk factors for venous thromboembolism.
• No contraindications for the use of Heparin.

You may not qualify if:

• Having mild risk factors for thromboembolism.
• Active vaginal bleeding.
• Thrombocytopaenia.
• any patient who is already on anticoagulant.
• Sever renal or Liver diseases.

Sponsors & Collaborators

• Hawler Medical University: lead

Study Sites (1)

Shahla Kareem Alalaf

Erbil, Kurdistan Region, 44001, Iraq

Location

MeSH Terms

Conditions

Venous Thrombosis; Pulmonary Embolism

Interventions

bemiparin

Condition Hierarchy (Ancestors)

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

Study Officials

• Shahla K. Alalaf, M.D

  Hawler Medical University

  PRINCIPAL INVESTIGATOR

• 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 CHAIR

• Namir G. Al Tawil, Professor

  Hawler Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 26, 2012
• First Posted: June 28, 2012
• Study Start: July 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

IR (1)