Deep Vein Thrombosis (DVT), Pulmonary Embolism
Conditions
Keywords
Thromboprophylaxis, Bemiparin, Low Molecular Weight Heparin, Major Gynaecological Surgeries, Benign Gynaecological Surgeries
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.
Interventions
DRUGBemiparin
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.
Sponsors
Hawler Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evidences of clinical thromboembolic disease after gynaecological surgeries | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| to determine the side effects of Bemiparin injection | 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, |
Countries
Iraq
Outcome results
None listed