Morbid ObesityNCT05569681
Two Different Regimens of Bemiparin as a Thromboprophylaxis in Morbidly Obese Surgical Patients
A study testing Bemiparin 3500 and Bemiparin 5000 IU in people with Morbid Obesity, run by Hawler Medical University at 1 site in Iraq.
Trial summary
Morbid obesity, is known to be associated with a high risk of VTE and, unfortunately, fixed doses of anticoagulant regimens may not provide optimal VTE prophylaxis in these patients especially after surgery. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Bemiparin 3500 and Bemiparin 5000 IU
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,248 participants
- Where
- 1 siteIraq
- Study dates
- 7 Jan 2023to 23 Oct 2026
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants required surgical intervention in: general surgery, gynecology, bariatric surgery
- Moderate, high, and very high risk for venous thromboembolism according to Caprin RAM
- Participant is willing and able to give informed consent for participation in the study.
- BMI ≥40kg/m2
Who cannot join
- Having any contraindication to LMWH, such as active bleeding, history of heparin-induced thrombocytopenia , baseline platelet count <75 × 108/μl, severe renal disease (glomerular filtration rate <30 ml/minute), severe liver disease, or uncontrolled hypertension (>200/120 mmHg)
- Known hypersensitivity to unfractionated or LMWHs
- On oral or parenteral anticoagulants within 5 days before surgery
- Severe arterial hypertension
- Unable to comply with the study treatment and/or follow-up
- Receiving prohibited medications
- Pregnancy or lactation mother
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Different Regimens of Bemiparin as a Thromboprophylaxis After Surgery in Morbidly Obese Patients: A Randomized, Outcome-assessor Blinded Trial.
Morbid obesity, is known to be associated with a high risk of VTE and, unfortunately, fixed doses of anticoagulant regimens may not provide optimal VTE prophylaxis in these patients especially after surgery.
Read the detailed description
Venous thromboembolism (VTE) is serious and preventable in patients who have undergone recent surgery . Most surgical patients are required to receive VTE prophylaxis, usually pharmacologic prophylaxis. Notwithstanding, rates of appropriate perioperative thromboprophylaxis remain tenaciously low, although the expansion of quality-improvement efforts has led to widespread hospital implementation of prophylaxis strategies.
Obesity, including morbid obesity, is known to be associated with a high risk of VTE and, unfortunately, fixed doses of anticoagulant regimens (unfractionated heparins, low-molecular-weight heparins, and factor Xa inhibitors) may not provide optimal VTE prophylaxis in these patients especially after surgery. Cumulative evidence and works of the literature suggest that anticoagulant dose adjustments in morbidly obese patients may reduce VTE risk. With the increasing rate of morbid obesity, more high-quality clinical trials are needed to prevent VTE in morbidly obese surgical patients providing effective, safe, prevention strategies.
Rationale for Change: Due to challenges in recruiting orthopedic surgical patients within the study timeframe, the protocol has been amended to exclude this patient population. This change ensures the study can proceed with a feasible sample size while maintaining the integrity of the research question regarding LMWH thromboprophylaxis in non-orthopedic surgical patients with morbid obesity. This amendment will not alter the primary research question regarding the efficacy and safety of two doses of LMWH thromboprophylaxis. However, it will narrow the scope of the study to focus exclusively on non-orthopedic surgical patients
- Conditions
- Morbid Obesity
- Being tested
- Bemiparin 3500, Bemiparin 5000 IU
- Keywords
- LMWH, Thromboprophylaxis, Non-orthopedic surgeries, Gynecological surgeries, General surgeries, Bariatric surgeries
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bemiparin 3500Drug
Also called Hibor 3500 IU
Bemiparin sodium 3,500 IU anti Xa/0.2 ml solution for injection in the pre-filled syringe will be provided for each patient in one group; subcutaneously 6 hours after the surgery(orthopedic and non-orthopedic) and then daily for up to 10 days for moderate and high - risk group and for 30 days in very high risk-group patients according to Caprinin risk classification for venous thromboembolism.
Other Name: Hibor; Laboratories Rovi Pharmaceuticals
Bemiparin 5000 IUDrug
Also called Hibor 5000 IU
Bemiparin sodium 5000 IU anti Xa/0.2 ml solution for injection in the pre-filled syringe will be provided for each patient in one group; subcutaneously 6 hours after the surgery(orthopedic and non-orthopedic) and then daily for up to 10 days for moderate and high - risk group and for 30 days in very high risk-group patients according to Caprinin risk classification for venous thromboembolism.
Other Name: Hibor; Laboratories Rovi Pharmaceuticals
| Study group | Role | What they receive |
|---|---|---|
| Bemiparin 3500 IU | Active comparator | Bemiparin sodium 3,500 IU anti Xa/0.2 ml solution for injection in the pre-filled syringe will be provided for each patient in one group; subcutaneously 6 hours after the surgery(orthopedic and non-orthopedic) and then daily for up to 10 days for moderate and high - risk group and for 30 days in very high risk-group patients according to Caprinin risk classification for venous thromboembolism.
Other Name: Hibor; Laboratories Rovi Pharmaceuticals Receives: Drug: Bemiparin 3500 |
| Bemiparin 5000 IU | Active comparator | Bemiparin sodium 5000 IU anti Xa/0.2 ml solution for injection in the pre-filled syringe will be provided for each patient in one group; subcutaneously 6 hours after the surgery(orthopedic and non-orthopedic) and then daily for up to 10 days for moderate and high - risk group patients and 30 days in very high-risk group surgical patients according to Caprinin risk classification for venous thromboembolism.
Other Name: Hibor; Laboratories Rovi Pharmaceuticals Receives: Drug: Bemiparin 5000 IU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with VTE events (Deep vein thrombosis or pulmonary embolism)
Deep vein thrombosis or pulmonary embolism will be confirmed by objective methods (Compression duplex ultrasound for deep vein thrombosis; perfusion/ventilation lung for pulmonary embolism )
Measured: up to 30 days after surgery
Secondary outcomes (1)
Side effects of both Bemiparin doses
Major bleedings,minor bleedings ,total bleeding events (major + minor),thrombocytopenia,injection site reactions, serious adverse events,discontinuations due to adverse side effects
Measured: 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 posted6 Oct 2022
- Study start7 Jan 2023
- Primary completion20 Oct 2026
- Study completion23 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies 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
- Model description
- Postsurgical morbidly obese patients will be randomized to receive 2 different doses of Bemiparin
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,248 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 ALALAF, Principal investigator, Hawler Medical UniversityAriana Jawad, Study chair, Kurdistan Higher Counsel of Medical SpecialtiesAbdulkader Alany, Study director, Hawler Medial UniversityAli Al-Dabbagh, Study chair, Hawler Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05569681
- Sponsor's protocol ID
- HMU4
- Status last verified
- Oct 2026
- First submitted
- 3 Oct 2022
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Different Regimens of Bemiparin as a Thromboprophylaxis After Surgery in Morbidly Obese Patients: A Randomized, Outcome-assessor Blinded Trial.
- ClinicalTrials.gov ID
- NCT05569681
- Acronym / sponsor ID
- HMU4
- Conditions
- Morbid Obesity
- Keywords
- LMWH, Thromboprophylaxis, Non-orthopedic surgeries, Gynecological surgeries, General surgeries, Bariatric surgeries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,248 participants (actual)
- Lead sponsor
- Hawler Medical UniversityUniversity, hospital or other
- Study start
- 7 Jan 2023 (actual)
- Primary completion
- 20 Oct 2026 (actual)
- Study completion
- 23 Oct 2026 (actual)
- First posted
- 6 Oct 2022 (actual)
- 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.
Morbid obesity, is known to be associated with a high risk of VTE and, unfortunately, fixed doses of anticoagulant regimens may not provide optimal VTE prophylaxis in these patients especially after surgery.
Detailed description
Venous thromboembolism (VTE) is serious and preventable in patients who have undergone recent surgery . Most surgical patients are required to receive VTE prophylaxis, usually pharmacologic prophylaxis. Notwithstanding, rates of appropriate perioperative thromboprophylaxis remain tenaciously low, although the expansion of quality-improvement efforts has led to widespread hospital implementation of prophylaxis strategies.
Obesity, including morbid obesity, is known to be associated with a high risk of VTE and, unfortunately, fixed doses of anticoagulant regimens (unfractionated heparins, low-molecular-weight heparins, and factor Xa inhibitors) may not provide optimal VTE prophylaxis in these patients especially after surgery. Cumulative evidence and works of the literature suggest that anticoagulant dose adjustments in morbidly obese patients may reduce VTE risk. With the increasing rate of morbid obesity, more high-quality clinical trials are needed to prevent VTE in morbidly obese surgical patients providing effective, safe, prevention strategies.
Rationale for Change: Due to challenges in recruiting orthopedic surgical patients within the study timeframe, the protocol has been amended to exclude this patient population. This change ensures the study can proceed with a feasible sample size while maintaining the integrity of the research question regarding LMWH thromboprophylaxis in non-orthopedic surgical patients with morbid obesity. This amendment will not alter the primary research question regarding the efficacy and safety of two doses of LMWH thromboprophylaxis. However, it will narrow the scope of the study to focus exclusively on non-orthopedic surgical patients
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Postsurgical morbidly obese patients will be randomized to receive 2 different doses of Bemiparin
| Arm | Type | Receives |
|---|---|---|
| Bemiparin 3500 IU | Active comparator | Drug: Bemiparin 3500Bemiparin sodium 3,500 IU anti Xa/0.2 ml solution for injection in the pre-filled syringe will be provided for each patient in one group; subcutaneously 6 hours after the surgery(orthopedic and non-orthopedic) and then daily for up to 10 days for moderate and high - risk group and for 30 days in very high risk-group patients according to Caprinin risk classification for venous thromboembolism. Other Name: Hibor; Laboratories Rovi Pharmaceuticals |
| Bemiparin 5000 IU | Active comparator | Drug: Bemiparin 5000 IUBemiparin sodium 5000 IU anti Xa/0.2 ml solution for injection in the pre-filled syringe will be provided for each patient in one group; subcutaneously 6 hours after the surgery(orthopedic and non-orthopedic) and then daily for up to 10 days for moderate and high - risk group patients and 30 days in very high-risk group surgical patients according to Caprinin risk classification for venous thromboembolism. Other Name: Hibor; Laboratories Rovi Pharmaceuticals |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants required surgical intervention in: general surgery, gynecology, bariatric surgery
- Moderate, high, and very high risk for venous thromboembolism according to Caprin RAM
- Participant is willing and able to give informed consent for participation in the study.
- BMI ≥40kg/m2
Key exclusion criteria (7 listed)
- Having any contraindication to LMWH, such as active bleeding, history of heparin-induced thrombocytopenia , baseline platelet count <75 × 108/μl, severe renal disease (glomerular filtration rate <30 ml/minute), severe liver disease, or uncontrolled hypertension (>200/120 mmHg)
- Known hypersensitivity to unfractionated or LMWHs
- On oral or parenteral anticoagulants within 5 days before surgery
- Severe arterial hypertension
- Unable to comply with the study treatment and/or follow-up
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 |
|---|---|---|
| Bemiparin 3500Also: Hibor 3500 IUBemiparin sodium 3,500 IU anti Xa/0.2 ml solution for injection in the pre-filled syringe will be provided for each patient in one group; subcutaneously 6 hours after the surgery(orthopedic and non-orthopedic) and then daily for up to 10 days for moderate and high - risk group and for 30 days in very high risk-group patients according to Caprinin risk classification for venous thromboembolism. Other Name: Hibor; Laboratories Rovi Pharmaceuticals | Drug | Bemiparin 3500 IU |
| Bemiparin 5000 IUAlso: Hibor 5000 IUBemiparin sodium 5000 IU anti Xa/0.2 ml solution for injection in the pre-filled syringe will be provided for each patient in one group; subcutaneously 6 hours after the surgery(orthopedic and non-orthopedic) and then daily for up to 10 days for moderate and high - risk group and for 30 days in very high risk-group patients according to Caprinin risk classification for venous thromboembolism. Other Name: Hibor; Laboratories Rovi Pharmaceuticals | Drug | Bemiparin 5000 IU |
Primary outcome
Number of participants with VTE events (Deep vein thrombosis or pulmonary embolism)
Time frame: up to 30 days after surgery
Deep vein thrombosis or pulmonary embolism will be confirmed by objective methods (Compression duplex ultrasound for deep vein thrombosis; perfusion/ventilation lung for pulmonary embolism )
1 secondary outcome
Side effects of both Bemiparin doses
Time frame: 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 27 Oct 2026.
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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 ALALAF principal investigator
Hawler Medical University
Ariana Jawad study chair
Kurdistan Higher Counsel of Medical Specialties
Abdulkader Alany study director
Hawler Medial 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 3500 and Bemiparin 5000 IU in people with Morbid Obesity, 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 4 inclusion and 7 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 27 Oct 2026. 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?
Number of participants with VTE events (Deep vein thrombosis or pulmonary embolism) (time frame: up to 30 days after surgery). 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 27 Oct 2026.