Bemiparin as a Thromboprophylaxis After Gynaecological Surgeries

Hawler Medical University

Status: Completed

Conditions: Pulmonary Embolism; Deep Vein Thrombosis (DVT)

Treatments: Drug: Bemiparin

Study type: Interventional

Funder types: Other

Identifiers

NCT01630148

HMU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 774 patients

Sex: Female

Ages: 15 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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774 participants in 2 patient groups

Bemiparin

Active Comparator group

Description:

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

Treatment:

Drug: Bemiparin

control group

No Intervention group

Description:

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.