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
- 2,400 participants
- Where
- 1 siteIraq
- Study dates
- 7 Jan 2023to 2 Oct 2026
- Phase
- Interventional
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. Contact the study team or a site near you to ask about taking part.
Iraq1 site, 1 recruiting
- Recruiting
Hawler Medical university
Erbil, Kurdistan Region, 44001
Nazar S. Pauls, PhD, 4450611 ext. 00964750, nazarpauls@yahoo.com
Abubakir S. Majeed, PhD, 4494656 ext. 00964750, info@zjms.org
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 completion25 Sep 2026 (estimated)
- Study completion2 Oct 2026 (estimated)
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
- None (open label)
- Enrolment
- 2,400 participants (estimated)
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
- Sep 2026
- First submitted
- 3 Oct 2022
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No