Deep Vein Thrombosis (DVT)NCT01630148
Bemiparin as a Thromboprophylaxis After Gynaecological Surgeries
A study testing Bemiparin in people with Deep Vein Thrombosis (DVT) and Pulmonary Embolism, run by Hawler Medical University at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 90 years, women only
- Conditions the study is for
- Deep Vein Thrombosis (DVT), Pulmonary Embolism
- What is being tested?
- Bemiparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 774 participants
- Where
- 1 siteIraq
- Study dates
- Jul 2012to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 90 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- female undergoing Benign gynecological surgeries.
- Having moderate,high and very high risk factors for venous thromboembolism.
- No contraindications for the use of Heparin.
Who cannot join
- Having mild risk factors for thromboembolism.
- Active vaginal bleeding.
- Thrombocytopaenia.
- any patient who is already on anticoagulant.
- Sever renal or Liver diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bemiparin as a Thromboprophylaxis After Benign Gynaecological Surgeries:A Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Deep Vein Thrombosis (DVT), Pulmonary Embolism
- Being tested
- Bemiparin
- Keywords
- Thromboprophylaxis, Bemiparin, Low Molecular Weight Heparin, Major Gynaecological Surgeries, Benign Gynaecological Surgeries
- Medical subject headings
- Venous Thrombosis, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BemiparinDrug
Also called Hibor; Laboratories Rovi pharmaceuticals
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.
| Study group | Role | What they receive |
|---|---|---|
| Bemiparin | Active comparator | group one will be women who are risky for venous thromboembolic diseases after benign gynaecological surgeries, each will receive Bemiparin Receives: Drug: Bemiparin |
| control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidences of clinical thromboembolic disease after gynaecological surgeries
to determine the efficacy of the new second generation LMWH in prevention Deep vein thrombosis and pulmonary embolism after gynaecological surgeries
Measured: within the first 30 days after surgery the first 30 days
Secondary outcomes (1)
to determine the side effects of Bemiparin injection
To determine the safety of Bemiparin after gynaecological surgeries including bruising or pain at site of injection,itching,allergic skin reactions,urticaria, bleeding,
Measured: after receiving the injections and up to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2012 (estimated)
- Study startJul 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Vein Thrombosis (DVT)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 774 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hawler Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SHAHLA KAREEM ALALAF, Hawler Medical University
- Investigators
- Shahla K. Alalaf, M.D, Principal investigator, Hawler Medical UniversityAriana K. Jawad, C.A.B.OG, Study chair, Hawler Ministry of HealthRojan K. Jawad, Diploma, Study chair, Hawler Medical UniversityMahabad S. Ali, Diploma, Study chair, Hawler Ministry of HealthNamir G. Al Tawil, Professor, Study director, Hawler Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01630148
- Sponsor's protocol ID
- HMU
- Status last verified
- Sep 2024
- First submitted
- 26 Jun 2012
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bemiparin as a Thromboprophylaxis After Benign Gynaecological Surgeries:A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01630148
- Acronym / sponsor ID
- HMU
- Conditions
- Deep Vein Thrombosis (DVT), Pulmonary Embolism
- Keywords
- Thromboprophylaxis, Bemiparin, Low Molecular Weight Heparin, Major Gynaecological Surgeries, Benign Gynaecological Surgeries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 774 participants (actual)
- Lead sponsor
- Hawler Medical UniversityUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 28 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bemiparin | Active comparator | Drug: Bemiparingroup one will be women who are risky for venous thromboembolic diseases after benign gynaecological surgeries, each will receive Bemiparin |
| control group | No intervention | –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. |
Who may qualify
- Ages
- 15 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- female undergoing Benign gynecological surgeries.
- Having moderate,high and very high risk factors for venous thromboembolism.
- No contraindications for the use of Heparin.
Key exclusion criteria (5 listed)
- Having mild risk factors for thromboembolism.
- Active vaginal bleeding.
- Thrombocytopaenia.
- any patient who is already on anticoagulant.
- Sever renal or Liver diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BemiparinAlso: Hibor; Laboratories Rovi pharmaceuticalsBemiparin 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. | Drug | Bemiparin |
Primary outcome
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
1 secondary outcome
to determine the side effects of Bemiparin injection
Time frame: after receiving the injections and up to 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shahla K. Alalaf, M.D principal investigator
Hawler Medical University
Ariana K. Jawad, C.A.B.OG study chair
Hawler Ministry of Health
Rojan K. Jawad, Diploma study chair
Hawler Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bemiparin in people with Deep Vein Thrombosis (DVT) and Pulmonary Embolism, run by Hawler Medical University at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidences of clinical thromboembolic disease after gynaecological surgeries (time frame: within the first 30 days after surgery the first 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.