ObesityPhase 4NCT01970202
Anti Xa Levels Under Two Different Regimens of Enoxaparin VTE Prophylaxis After Sleeve Gastrectomy for Morbid Obesity
A Phase 4 study testing 40mg Enoxaparin and 60mg Enoxaparin in people with Obesity, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
Approximately two thirds of the adult population in developed countries is categorized as over-weight or obese (BMI>30). In spite of worldwide increasing awareness, obesity is a major health concern. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- 40mg Enoxaparin and 60mg Enoxaparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2013to Jul 2016
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient undergoing laparoscopic sleeve gastrectomy.
- The patient undergoes the surgery in the surgical wing of the Tel-Aviv Sourasky Medical Center.
- The patient has received full information regarding the studies nature, has agreed to participate and has given informed consent (documented by a signed informed consent form).
Who cannot join
- Patients with a previous Venous Thromboembolic Event.
- Patients requiring an IVC filter.
- Patients with known thrombophilia due to coagulation factor disorders (i.e factor V leiden).
- Patients with a bleeding disorder
- Patients with renal failure.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Tel Aviv Sourasky medical center
Tel Aviv
Guy Lahat, MD, 972527360237, guyla@tlvmc.gov.il
About this study
Official title: Comparing the Efficacy of Two Frequently Used Doses of Enoxaparin for VTE Prophylaxis After Bariatric Surgery
Approximately two thirds of the adult population in developed countries is categorized as over-weight or obese (BMI>30). In spite of worldwide increasing awareness, obesity is a major health concern. In the presence of numerous diets, medical therapies, and robust research, bariatric surgery remains the most effective means of weight reduction in morbidly obese patients (BMI>40, or BMI>35 with co-morbidities). However, bariatric surgery harbors a relatively high risk for postoperative complications; of them, venous thromboembolic events (VTE) are not common, but potentially lethal. Taken together with the propensity of morbidly obese patients to develop VTE, perioperative thromboprophylaxis is mandatory.
To date, low molecular weight heparins (LMWH) are most commonly used for VTE prophylaxis in the aforementioned population. Due to the pharmacologic properties of LMWH and the characteristics of surgically treated obese patients, the optimal dose that is to be utilized for VTE prophylaxis in this population remains unclear. Assessment of anti-FXa levels in the patients' plasma can be used in order to monitor LMWH activity. Levels of 0.2-0.5 U/ml have been proposed by some authors for VTE prophylaxis.
Read more
Few studies have compared different dosing regimens of enoxaparin (between 30mg-60mg q/12h) for VTE prophylaxis in the population undergoing bariatric surgery; nevertheless, these were small non- randomized trials, containing numerous methodological weaknesses. Hence, the optimal regimen of enoxaparin to be used for the prevention of VTE in the discussed population remains unclear.
The aim of the present study is to evaluate plasma levels of anti-FXa activity, comparing two most commonly used enoxaparin prophylactic regimens (40mg vs 60mg q/24h) in a large and homogenous cohort of sleeve gastrectomy patients. Although universally used by bariatric surgeons, the pharmacologic efficacy of these regimens has not been evaluated in patients undergoing bariatric surgery.
Read the detailed description
The following steps shall be performed in the process of recruiting a patient for the study:
Preoperatively:
- A baseline blood sample for Anti-FXa levels shall be obtained.
- Randomization of the patient to one of the two treatment groups
Postoperatively:
- All patients will be treated with Sequential Compression Devices, massive I.V hydration and encouraged to ambulate early.
- Patients will receive three injections of enoxaparin, according to the treatment group they were assigned to, The first injection given on the morning after surgery. Four hours after the third injection of enoxaparin a blood sample will be taken from the patients and assessed for anti-FXa levels.
A control group of 5 patients, randomly elected, will be recruited. This group will not be treated with enoxaparin. These patients will be treated with sequential compression devices and massive I.V hydration, an accepted treatment, proven effective for the studied population. The goal is to assess the anti-FXa levels in these patients, representing the baseline levels in patients undergoing laparoscopic sleeve gastrectomy.
Furthermore, the preoperative, operative and postoperative management of these patients will be identical to that of the treatment groups and on the third day post-operation a blood sample from these patients will be retrieved and assessed for anti-FXa levels.
- Conditions
- Obesity
- Being tested
- 40mg Enoxaparin, 60mg Enoxaparin, Control
- Keywords
- obesity, overweight, sleeve gastrectomy
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
40mg EnoxaparinDrug
Also called clexane
Patients with obesity undergoing laparoscopic sleeve gastrectomy, will receive 40mg Enoxaparin per day for 3 days after surgery by subcutaneous administration.
60mg EnoxaparinDrug
Also called clexane
Patients with obesity undergoing laparoscopic sleeve gastrectomy, will receive 60mg Enoxaparin per day for 3 days after surgery by subcutaneous administration.
ControlOther
no treatment
| Study group | Role | What they receive |
|---|---|---|
| 40mg Enoxaparin | Active comparator | Patients with obesity undergoing laparoscopic sleeve gastrectomy, will receive 40mg Enoxaparin per day for 3 days after surgery by subcutaneous administration. Receives: Drug: 40mg Enoxaparin |
| 60mg Enoxaparin | Active comparator | Patients with obesity undergoing laparoscopic sleeve gastrectomy, will receive 60mg Enoxaparin per day for 3 days after surgery by subcutaneous administration. Receives: Drug: 60mg Enoxaparin |
| Control | Other | no treatment Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-factor Xa plasma levels
Measured: within 3 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 posted28 Oct 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2015 (estimated)
- Study completionJul 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 ObesityStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Nachum vaisman, Prof, Tel-Aviv Sourasky Medical Center
- Investigators
- Guy Lahat, MD, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01970202
- Sponsor's protocol ID
- TASMC-13-GL-0241-CTIL
- Status last verified
- Oct 2013
- First submitted
- 14 Oct 2013
- Last updated
- 28 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
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 28 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy of Two Frequently Used Doses of Enoxaparin for VTE Prophylaxis After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT01970202
- Acronym / sponsor ID
- TASMC-13-GL-0241-CTIL
- Conditions
- Obesity
- Keywords
- obesity, overweight, sleeve gastrectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Nov 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 28 Oct 2013 (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.
Approximately two thirds of the adult population in developed countries is categorized as over-weight or obese (BMI>30). In spite of worldwide increasing awareness, obesity is a major health concern. In the presence of numerous diets, medical therapies, and robust research, bariatric surgery remains the most effective means of weight reduction in morbidly obese patients (BMI>40, or BMI>35 with co-morbidities). However, bariatric surgery harbors a relatively high risk for postoperative complications; of them, venous thromboembolic events (VTE) are not common, but potentially lethal. Taken together with the propensity of morbidly obese patients to develop VTE, perioperative thromboprophylaxis is mandatory.
To date, low molecular weight heparins (LMWH) are most commonly used for VTE prophylaxis in the aforementioned population. Due to the pharmacologic properties of LMWH and the characteristics of surgically treated obese patients, the optimal dose that is to be utilized for VTE prophylaxis in this population remains unclear. Assessment of anti-FXa levels in the patients' plasma can be used in order to monitor LMWH activity. Levels of 0.2-0.5 U/ml have been proposed by some authors for VTE prophylaxis.
Few studies have compared different dosing regimens of enoxaparin (between 30mg-60mg q/12h) for VTE prophylaxis in the population undergoing bariatric surgery; nevertheless, these were small non- randomized trials, containing numerous methodological weaknesses. Hence, the optimal regimen of enoxaparin to be used for the prevention of VTE in the discussed population remains unclear.
The aim of the present study is to evaluate plasma levels of anti-FXa activity, comparing two most commonly used enoxaparin prophylactic regimens (40mg vs 60mg q/24h) in a large and homogenous cohort of sleeve gastrectomy patients. Although universally used by bariatric surgeons, the pharmacologic efficacy of these regimens has not been evaluated in patients undergoing bariatric surgery.
Detailed description
The following steps shall be performed in the process of recruiting a patient for the study:
Preoperatively:
- A baseline blood sample for Anti-FXa levels shall be obtained.
- Randomization of the patient to one of the two treatment groups
Postoperatively:
- All patients will be treated with Sequential Compression Devices, massive I.V hydration and encouraged to ambulate early.
- Patients will receive three injections of enoxaparin, according to the treatment group they were assigned to, The first injection given on the morning after surgery. Four hours after the third injection of enoxaparin a blood sample will be taken from the patients and assessed for anti-FXa levels.
A control group of 5 patients, randomly elected, will be recruited. This group will not be treated with enoxaparin. These patients will be treated with sequential compression devices and massive I.V hydration, an accepted treatment, proven effective for the studied population. The goal is to assess the anti-FXa levels in these patients, representing the baseline levels in patients undergoing laparoscopic sleeve gastrectomy.
Furthermore, the preoperative, operative and postoperative management of these patients will be identical to that of the treatment groups and on the third day post-operation a blood sample from these patients will be retrieved and assessed for anti-FXa levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 40mg Enoxaparin | Active comparator | Drug: 40mg EnoxaparinPatients with obesity undergoing laparoscopic sleeve gastrectomy, will receive 40mg Enoxaparin per day for 3 days after surgery by subcutaneous administration. |
| 60mg Enoxaparin | Active comparator | Drug: 60mg EnoxaparinPatients with obesity undergoing laparoscopic sleeve gastrectomy, will receive 60mg Enoxaparin per day for 3 days after surgery by subcutaneous administration. |
| Control | Other | Other: Controlno treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patient undergoing laparoscopic sleeve gastrectomy.
- The patient undergoes the surgery in the surgical wing of the Tel-Aviv Sourasky Medical Center.
- The patient has received full information regarding the studies nature, has agreed to participate and has given informed consent (documented by a signed informed consent form).
Key exclusion criteria (5 listed)
- Patients with a previous Venous Thromboembolic Event.
- Patients requiring an IVC filter.
- Patients with known thrombophilia due to coagulation factor disorders (i.e factor V leiden).
- Patients with a bleeding disorder
- Patients with renal failure.
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 |
|---|---|---|
| 40mg EnoxaparinAlso: clexanePatients with obesity undergoing laparoscopic sleeve gastrectomy, will receive 40mg Enoxaparin per day for 3 days after surgery by subcutaneous administration. | Drug | 40mg Enoxaparin |
| 60mg EnoxaparinAlso: clexanePatients with obesity undergoing laparoscopic sleeve gastrectomy, will receive 60mg Enoxaparin per day for 3 days after surgery by subcutaneous administration. | Drug | 60mg Enoxaparin |
| Controlno treatment | Other | Control |
Primary outcome
Anti-factor Xa plasma levels
Time frame: within 3 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2013.
- 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.
Guy Lahat, MD principal investigator
Tel-Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 40mg Enoxaparin and 60mg Enoxaparin in people with Obesity, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 3 inclusion and 5 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 28 Oct 2013. 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 Israel. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Guy Lahat, MD (972527360237, guyla@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-factor Xa plasma levels (time frame: within 3 days after surgery). 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 NCT01970202, 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 28 Oct 2013.