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CompletedNCT05569681Updated Oct 27, 2026

Two Different Regimens of Bemiparin as a Thromboprophylaxis in Morbidly Obese Surgical Patients

An interventional study of Bemiparin 3500 and Bemiparin 5000 IU in Morbid Obesity, sponsored by Hawler Medical University. Completed at 1 site in Iraq. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by Hawler Medical University · Not applicable, Interventional, and Prevention

Updated Oct 27, 2026Now CompletedPrimary completion moved+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
1,248
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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 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

02

Conditions studied

  • Morbid Obesity

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Keywords

  • LMWH
  • Thromboprophylaxis
  • Non-orthopedic surgeries
  • Gynecological surgeries
  • General surgeries
  • Bariatric surgeries
03

In context

Obesity, Morbid

941 studies on the registry are indexed under Obesity, Morbid; 163 are open to participants now.

This study's enrollment of 1,248 is above the median of 62 across 602 interventional studies indexed under Obesity, Morbid.

Browse Obesity, Morbid studies →

Lead sponsor

Hawler Medical University is the lead sponsor of 59 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Participants required surgical intervention in: general surgery, gynecology, bariatric surgery
  2. Moderate, high, and very high risk for venous thromboembolism according to Caprin RAM
  3. Participant is willing and able to give for participation in the study.
  4. ≥40kg/m2

Exclusion criteria

Exclusion Criteria:

  1. Having any to LMWH, such as active bleeding, history of heparin-induced thrombocytopenia , baseline count \<75 × 108/μl, severe renal disease ( \<30 ml/minute), severe liver disease, or uncontrolled hypertension (>200/120 mmHg)
  2. Known to unfractionated or LMWHs
  3. On oral or parenteral anticoagulants within 5 days before surgery
  4. Severe arterial hypertension
  5. Unable to comply with the study treatment and/or follow-up
  6. Receiving prohibited medications
  7. Pregnancy or lactation mother
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
1,248 participants (actual)

Study arms

  • Active comparator
    Bemiparin 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

    Drug: Bemiparin 3500

  • Active comparator
    Bemiparin 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 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

    Drug: Bemiparin 5000 IU

Interventions

  • DrugBemiparin 3500

    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

    Also known as: Hibor 3500 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

    Also known as: Hibor 5000 IU

06

What researchers measure

Primary outcomes

  1. 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 )

    Time frame: 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

    Time frame: up to 30 days after surgery

07

Study locations

1 site
  • Hawler Medical university
    Erbil, Kurdistan Region 44001, Iraq
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2023 to primary completion in Oct 2026, 45 months.

Of 274 non-industry interventional studies with no phase under Obesity, Morbid, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 48. This study's 45 months is above that.

Counting every sponsor, half of 286 studies reached it within 25 months; a quarter within 11 and three quarters within 48.

Primary completion moved once since we started tracking on Sep 25, 2026: Sep 2026 → Oct 2026, on Oct 27, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Oct 3, 2022
First posted
Oct 6, 2022
StartActual
Jan 7, 2023
Primary completionActual
Oct 20, 2026was Sep 2026
CompletionActual
Oct 23, 2026
Last update
Oct 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Completed
changed Oct 27, 2026
Primary completion
Sep 25, 2026→Oct 20, 2026 (actual)
Oct 27, 2026
Study completion
Oct 2, 2026→Oct 23, 2026 (actual)
Oct 27, 2026
Enrollment
2400 (estimated)→1248 (actual)
Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    Recruiting→Completed
    Primary completion Sep 25, 2026→Oct 20, 2026 (now actual)
    Study completion Oct 2, 2026→Oct 23, 2026 (now actual)
    Enrollment 2400 (estimated)→1248 (actual)
    + 4 other changes: verification date, design details, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT05569681
Lead sponsor
Hawler Medical University
Responsible party
SHAHLA KAREEM ALALAF (Professor, Hawler Medical University) — Principal investigator
First posted
Oct 6, 2022
Start date
Jan 7, 2023
Primary completion
Oct 20, 2026
Completion
Oct 23, 2026
Last update
Oct 27, 2026

Study contacts

SHAHLA ALALAF
principal investigator · Hawler Medical University
Ariana Jawad
study chair · Kurdistan Higher Counsel of Medical Specialties
Abdulkader Alany
study director · Hawler Medial University
Ali Al-Dabbagh
study chair · Hawler Medical University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Bemiparin

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