Bemiparin as a Thromboprophylaxis After Gynaecological Surgeries
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 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|
- 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
- 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,
|Study Start Date:||July 2012|
|Study Completion Date:||March 2014|
|Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Bemiparin
group one will be cases who are risky for venous thromboembolic diseases after benign gynaecological surgeries, each will receive 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
cases 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.
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 VTE is estimated to be 3% after gynaecological surgery if no thromboprophylaxis was used. The rate of VTE assumed to decrease to 0.04% if Low molecular weight heparin was 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01630148
|Hawler medical university|
|Erbil city, Kurdistan region, Iraq, 383-65|
|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|