Anti Xa Levels Under Two Different Regimens of Enoxaparin VTE Prophylaxis After Sleeve Gastrectomy for Morbid Obesity
NCT ID: NCT01970202
Last Updated: 2013-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
55 participants
INTERVENTIONAL
2013-11-30
2016-07-31
Brief Summary
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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
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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40mg Enoxaparin
Patients with obesity undergoing laparoscopic sleeve gastrectomy, will receive 40mg Enoxaparin per day for 3 days after surgery by subcutaneous administration.
40mg Enoxaparin
Patients with obesity undergoing laparoscopic sleeve gastrectomy, will receive 40mg Enoxaparin per day for 3 days after surgery by subcutaneous administration.
60mg Enoxaparin
Patients with obesity undergoing laparoscopic sleeve gastrectomy, will receive 60mg Enoxaparin per day for 3 days after surgery by subcutaneous administration.
60mg Enoxaparin
Patients with obesity undergoing laparoscopic sleeve gastrectomy, will receive 60mg Enoxaparin per day for 3 days after surgery by subcutaneous administration.
Control
no treatment
Control
no treatment
Interventions
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40mg Enoxaparin
Patients with obesity undergoing laparoscopic sleeve gastrectomy, will receive 40mg Enoxaparin per day for 3 days after surgery by subcutaneous administration.
60mg Enoxaparin
Patients with obesity undergoing laparoscopic sleeve gastrectomy, will receive 60mg Enoxaparin per day for 3 days after surgery by subcutaneous administration.
Control
no treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Tel-Aviv Sourasky Medical Center
OTHER_GOV
Responsible Party
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Nachum vaisman, Prof
Principle investigator
Principal Investigators
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Guy Lahat, MD
Role: PRINCIPAL_INVESTIGATOR
Tel-Aviv Sourasky Medical Center
Locations
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Tel Aviv Sourasky medical center
Tel Aviv, , Israel
Countries
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Central Contacts
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Facility Contacts
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Guy Lahat, MD
Role: primary
References
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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.
Other Identifiers
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TASMC-13-GL-0241-CTIL
Identifier Type: -
Identifier Source: org_study_id