Bemiparin as a Thromboprophylaxis After Gynaecological Surgeries

• ClinicalTrials.gov Identifier: NCT01630148
• Recruitment Status: Completed
• First Posted: June 28, 2012
• Last Update Posted: October 6, 2014
• Sponsor: Hawler Medical University
• Information provided by (Responsible Party): Assistant Prof. Shahla Alalaf, Hawler Medical University

Tracking Information

• First Submitted Date: June 26, 2012
• First Posted Date: June 28, 2012
• Last Update Posted Date: October 6, 2014
• Study Start Date: July 2012
• Actual Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 27, 2012)

Evidences of clinical thromboembolic disease after gynaecological surgeries [ Time Frame: within the first 30 days after surgery the first 30 days ]

to determine the efficacy of the new second generation LMWH in prevention Deep vein thrombosis and pulmonary embolism after gynaecological surgeries

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 27, 2012)

to determine the side effects of Bemiparin injection [ Time Frame: after receiving the injections and up to 30 days after surgery ]

To determine the safety of Bemiparin after gynaecological surgeries including bruising or pain at site of injection,itching,allergic skin reactions,urticaria, bleeding,

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Bemiparin as a Thromboprophylaxis After Gynaecological Surgeries
• Official Title: Bemiparin as a Thromboprophylaxis After Benign Gynaecological Surgeries:A Randomized Clinical Trial
• 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.

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
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Prevention

Condition

• Deep Vein Thrombosis (DVT)
• Pulmonary Embolism

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.

Other Name: Hibor; Laboratories Rovi pharmaceuticals

Study Arms

• Active Comparator: Bemiparin
  group one will be women who are risky for venous thromboembolic diseases after benign gynaecological surgeries, each will receive Bemiparin
  Intervention: Drug: Bemiparin
• 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.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 27, 2012): 774
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: March 2014
• Actual Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 15 Years to 90 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Iraq

Administrative Information

• NCT Number: NCT01630148
• Other Study ID Numbers: HMU
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Assistant Prof. Shahla Alalaf, Hawler Medical University
• Study Sponsor: Hawler Medical University
• Collaborators: Not Provided

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

• PRS Account: Hawler Medical University
• Verification Date: October 2014