Bemiparin as a Thromboprophylaxis After Gynaecological Surgeries
This study is currently recruiting participants.
Verified February 2013 by Hawler Medical University
Sponsor:
Hawler Medical University
Information provided by (Responsible Party):
Assistant Prof. Shahla Alalaf, Hawler Medical University
ClinicalTrials.gov Identifier:
NCT01630148
First received: June 26, 2012
Last updated: February 8, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Deep Vein Thrombosis (DVT) Pulmonary Embolism |
Drug: Bemiparin |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Further study details as provided by Hawler Medical University:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- 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,
| Estimated Enrollment: | 774 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Bemiparin
group one will be cases who are risky for venous thromboembolic diseases after benign gynaecological surgeries, each will receive Bemiparin
|
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
|
|
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.
|
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 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.
Eligibility| Ages Eligible for Study: | 25 Years to 90 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01630148
Contacts
| Contact: Nazar P. Shabila, PHD | 07504450611 ext 00964 | nazarpauls@yahoo.com |
| Contact: Abubakir M. Salih, MSc,C.H.M | 07504494656 ext 00964 | abubakir.majeed@hmu.edu.iq |
Locations
| Iraq | |
| Hawler medical university | Recruiting |
| Erbil city, Kurdistan region, Iraq, 383-65 | |
| Contact: Nazar P. Shabila, PHD 07504450611 ext 00964 nazarpauls@yahoo.com | |
| Contact: Abubakir M. Saleh, Msc.C.H.M 07504494656 ext 00964 abubakir.majeed@hmu.edu.iq | |
| Principal Investigator: Shahla K. Alalaf, M.D | |
Sponsors and Collaborators
Hawler Medical University
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, A.Prof | Hawler Medical University |
More Information
No publications provided
| Responsible Party: | Assistant Prof. Shahla Alalaf, Assistant Professor, Hawler Medical University |
| ClinicalTrials.gov Identifier: | NCT01630148 History of Changes |
| Other Study ID Numbers: | HMU |
| Study First Received: | June 26, 2012 |
| Last Updated: | February 8, 2013 |
| Health Authority: | North of Iraq, Kurdistan region:Hawler Directorate of Health |
Keywords provided by Hawler Medical University:
|
Thromboprophylaxis Bemiparin Low Molecular Weight Heparin Major Gynaecological Surgeries Benign Gynaecological Surgeries |
Additional relevant MeSH terms:
|
Embolism Pulmonary Embolism Thrombosis Venous Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases |
Heparin, Low-Molecular-Weight Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 19, 2013