Bemiparin as a Thromboprophylaxis After Gynaecological Surgeries
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|ClinicalTrials.gov Identifier: NCT01630148|
Recruitment Status : Completed
First Posted : June 28, 2012
Last Update Posted : October 6, 2014
|Condition or disease||Intervention/treatment||Phase|
|Deep Vein Thrombosis (DVT) Pulmonary Embolism||Drug: Bemiparin||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||774 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Bemiparin as a Thromboprophylaxis After Benign Gynaecological Surgeries:A Randomized Clinical Trial|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2014|
Active Comparator: Bemiparin
group one will be women 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
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.
- 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
- 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,
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|