Deep Venous ThrombosisPhase 1NCT06913595
Low Molecular Weight Heparin vs Direct Oral Anticoagulant After Bariatric Surgery
A Phase 1 study testing Direct Oral Anticoagulant. and Low Molecular Weight Heparine in people with Deep Venous Thrombosis, run by Cairo University at 1 site in Egypt.
Trial summary
Extended Venous Thromboemboism Prophylaxis After Bariatric Surgeries: A Comparison Of Low Molecular Weight Heparin With Direct Oral Anticoagulant Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Deep Venous Thrombosis
- What is being tested?
- Direct Oral Anticoagulant. and Low Molecular Weight Heparine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Mar 2024to 1 Nov 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- BARIATRIC PATIENTS
Who cannot join
- BLEEDING TENDENCY
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Extended Venous Thromboemboism Prophylaxis After Bariatric Surgeries: A Comparison Of Low Molecular Weight Heparin With Direct Oral Anticoagulant
Extended Venous Thromboemboism Prophylaxis After Bariatric Surgeries: A Comparison Of Low Molecular Weight Heparin With Direct Oral Anticoagulant
Read the detailed description
This study aims to compare the effectiveness of rivaroxaban versus low molecular weight heparin in reducing the incidence of PMVT after bariatric surgery.
- Conditions
- Deep Venous Thrombosis
- Being tested
- Direct Oral Anticoagulant., Low Molecular Weight Heparine
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct Oral Anticoagulant.Drug
Also called RIVROXABAN
Direct Oral Anticoagulant AFTER BARIATRIC SURGERY
Low Molecular Weight HeparineDrug
Also called Enoxaparine
Low molecular weight heparin after bariatric surgery
| Study group | Role | What they receive |
|---|---|---|
| Low Molecular Weight Heparin | Active comparator | Low molecular weight heparin as aprophylaxis after bariatric surgery Receives: Drug: Low Molecular Weight Heparine |
| Direct Oral Anticoagulant. | Experimental | Direct Oral Anticoagulant as aprophylaxis after bariatric surgery Receives: Drug: Direct Oral Anticoagulant. |
What is being measured
The primary outcome is the main question the study is designed to answer.
VENOUS THROMBOEMBOLISM
DVT after bariatric surgery
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start25 Mar 2024
- Primary completion25 Oct 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Venous ThrombosisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Elshwadfy Nageeb, Cairo University
- Investigators
- mohammed elshwadfy, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06913595
- Sponsor's protocol ID
- N-55-2024
- Status last verified
- Aug 2025
- First submitted
- 24 Mar 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Venous Thromboemboism Prophylaxis After Bariatric Surgeries: A Comparison Of Low Molecular Weight Heparin With Direct Oral Anticoagulant
- ClinicalTrials.gov ID
- NCT06913595
- Acronym / sponsor ID
- N-55-2024
- Conditions
- Deep Venous Thrombosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- 25 Oct 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 6 Apr 2025 (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.
Extended Venous Thromboemboism Prophylaxis After Bariatric Surgeries: A Comparison Of Low Molecular Weight Heparin With Direct Oral Anticoagulant
Detailed description
This study aims to compare the effectiveness of rivaroxaban versus low molecular weight heparin in reducing the incidence of PMVT after bariatric surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Molecular Weight Heparin | Active comparator | Drug: Low Molecular Weight HeparineLow molecular weight heparin as aprophylaxis after bariatric surgery |
| Direct Oral Anticoagulant. | Experimental | Drug: Direct Oral Anticoagulant.Direct Oral Anticoagulant as aprophylaxis after bariatric surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- BARIATRIC PATIENTS
Key exclusion criteria (1 listed)
- BLEEDING TENDENCY
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 |
|---|---|---|
| Direct Oral Anticoagulant.Also: RIVROXABANDirect Oral Anticoagulant AFTER BARIATRIC SURGERY | Drug | Direct Oral Anticoagulant. |
| Low Molecular Weight HeparineAlso: EnoxaparineLow molecular weight heparin after bariatric surgery | Drug | Low Molecular Weight Heparin |
Primary outcome
VENOUS THROMBOEMBOLISM
Time frame: 1 year
DVT after bariatric surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Individual participant dataSharing planned: No
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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.
mohammed elshwadfy principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Direct Oral Anticoagulant. and Low Molecular Weight Heparine in people with Deep Venous Thrombosis, run by Cairo University at 1 site in Egypt.
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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 26 Aug 2025. 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 Egypt. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
VENOUS THROMBOEMBOLISM (time frame: 1 year). 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 26 Aug 2025.