Morbid ObesityPhase 1/2NCT02128178
Laparoscopic Bariatric Surgery: Two Regimens of Venous Thromboprophylaxis: Prospective Randomized Study
A Phase 1/2 study testing Enoxaparin 40 mg 2 hours before arm and Enoxaparin 40 mg 12 hours before arm in people with Morbid Obesity and Pulmonary Embolism, run by Mansoura University at 1 site in Egypt.
Trial summary
Obese patients undergoing bariatric surgery warrant VTE prophylaxis because they are at high risk for developing a fatal pulmonary embolism or postthrombotic syndrome. However, a consensus does not exist on the most effective prophylactic approach. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Morbid Obesity, Pulmonary Embolism
- What is being tested?
- Enoxaparin 40 mg 2 hours before arm and Enoxaparin 40 mg 12 hours before arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2013to May 2016
- Phase
- Phase 1/2
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- BMI >40 OR >35 with comorbidities
Who cannot join
- No
Trial locations and contacts
1 site in 1 country.
mohamed e abd ellatif, phd contact
Egypt1 site, 1 recruiting
- Recruiting
Manoura University
Al Mansurah
mohamed e abd ellatif, phd, surg_latif@hotmail.com
mohamed e abd ellatif, phd
About this study
Obese patients undergoing bariatric surgery warrant VTE prophylaxis because they are at high risk for developing a fatal pulmonary embolism or postthrombotic syndrome. However, a consensus does not exist on the most effective prophylactic approach.
Read the detailed description
Two regimens of prophylaxis are supposed , the 1st one is to give enoxaparin 40mg 2 hours before surgery and continued daily for 10 days after, and the 2nd one is to start 12 hours before surgery and continued in the same way like the 1st one.
- Conditions
- Morbid Obesity, Pulmonary Embolism
- Being tested
- Enoxaparin 40 mg 2 hours before arm, Enoxaparin 40 mg 12 hours before arm
- Keywords
- Morbid obesity, Laparoscopic surgery, Compression ultrasonography, Pulmonary embolism, Bleeding
- Medical subject headings
- Obesity, Morbid, Pulmonary Embolism, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enoxaparin 40 mg 2 hours before armDrug
Also called First group
Enoxaparin 40 mg 2 hours before surgery
Enoxaparin 40 mg 12 hours before armDrug
Also called second group
Enoxaparin 40 mg 12 hours before surgery
| Study group | Role | What they receive |
|---|---|---|
| ENOXAPARIN 2 HOURS BEFORE | Active comparator | Giving 40 mg enoxaparin SQ 2 hours before surgery and daily for 10 days thereafter Receives: Drug: Enoxaparin 40 mg 2 hours before arm; Drug: Enoxaparin 40 mg 12 hours before arm |
| Enoxaparin 40 mg 12 hours before | Active comparator | Enoxaparin 40 mg 12 hours before surgery and once daily for 10 days thereafter Receives: Drug: Enoxaparin 40 mg 2 hours before arm; Drug: Enoxaparin 40 mg 12 hours before arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Venous thrombosis and/or pulmonary embolism (PE)
To assess the venous thrombosis by compression ultrasonography and PE in suspected patients
Measured: Postoperative 4 weeks
Secondary outcomes (2)
Bleeding from the surgery site , drain if any, GIT bleeding,
Bleeding from drain, GIT, or wounds are assessed clinically
Measured: postoperative 4 weeks
hospital stay
hospital stay in days
Measured: 4 WEEKS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study startNov 2013
- Primary completionApr 2016 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by Mansoura 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MOHAMED ABDELLATIF, Mansoura University
- Investigators
- mohamed e abd ellatif, phd, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02128178
- Sponsor's protocol ID
- Enoxaparin
- Status last verified
- Apr 2015
- First submitted
- 22 Apr 2014
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Amaral FC, Baptista-Silva JC, Nakano LC, Flumignan RL. Pharmacological interventions for preventing venous thromboembolism in people undergoing bariatric surgery. Cochrane Database Syst Rev. 2022 Nov 22;11(11):CD013683. doi: 10.1002/14651858.CD013683.pub2.
PubMed 36413425
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Bariatric Surgery: Two Regimens of Venous Thromboprophylaxis: Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT02128178
- Acronym / sponsor ID
- Enoxaparin
- Conditions
- Morbid Obesity, Pulmonary Embolism
- Keywords
- Morbid obesity, Laparoscopic surgery, Compression ultrasonography, Pulmonary embolism, Bleeding
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Apr 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 1 May 2014 (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.
Obese patients undergoing bariatric surgery warrant VTE prophylaxis because they are at high risk for developing a fatal pulmonary embolism or postthrombotic syndrome. However, a consensus does not exist on the most effective prophylactic approach.
Detailed description
Two regimens of prophylaxis are supposed , the 1st one is to give enoxaparin 40mg 2 hours before surgery and continued daily for 10 days after, and the 2nd one is to start 12 hours before surgery and continued in the same way like the 1st one.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ENOXAPARIN 2 HOURS BEFORE | Active comparator | Drug: Enoxaparin 40 mg 2 hours before arm, Drug: Enoxaparin 40 mg 12 hours before armGiving 40 mg enoxaparin SQ 2 hours before surgery and daily for 10 days thereafter |
| Enoxaparin 40 mg 12 hours before | Active comparator | Drug: Enoxaparin 40 mg 2 hours before arm, Drug: Enoxaparin 40 mg 12 hours before armEnoxaparin 40 mg 12 hours before surgery and once daily for 10 days thereafter |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- BMI >40 OR >35 with comorbidities
Key exclusion criteria (1 listed)
- No
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 |
|---|---|---|
| Enoxaparin 40 mg 2 hours before armAlso: First groupEnoxaparin 40 mg 2 hours before surgery | Drug | ENOXAPARIN 2 HOURS BEFORE, Enoxaparin 40 mg 12 hours before |
| Enoxaparin 40 mg 12 hours before armAlso: second groupEnoxaparin 40 mg 12 hours before surgery | Drug | ENOXAPARIN 2 HOURS BEFORE, Enoxaparin 40 mg 12 hours before |
Primary outcome
Venous thrombosis and/or pulmonary embolism (PE)
Time frame: Postoperative 4 weeks
To assess the venous thrombosis by compression ultrasonography and PE in suspected patients
2 secondary outcomes
Bleeding from the surgery site , drain if any, GIT bleeding,
Time frame: postoperative 4 weeks
hospital stay
Time frame: 4 WEEKS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2015.
- Derived from this study: PubMed 36413425Amaral FC, Baptista-Silva JC, Nakano LC, Flumignan RL. Pharmacological interventions for preventing venous thromboembolism in people undergoing bariatric surgery. Cochrane Database Syst Rev. 2022 Nov 22;11(11):CD013683. doi: 10.1002/14651858.CD013683.pub2.
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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.
mohamed e abd ellatif, phd contact
mohamed e abd ellatif, phd principal investigator
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Enoxaparin 40 mg 2 hours before arm and Enoxaparin 40 mg 12 hours before arm in people with Morbid Obesity and Pulmonary Embolism, run by Mansoura 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: status not confirmed, as of the sponsor's last update on 8 Apr 2015. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mohamed e abd ellatif, phd (surg_latif@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Venous thrombosis and/or pulmonary embolism (PE) (time frame: Postoperative 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02128178, which also lists 1 linked publication.
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 8 Apr 2015.