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Anti Xa Levels Under Two Different Regimens of Enoxaparin VTE Prophylaxis After Sleeve Gastrectomy for Morbid Obesity

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ClinicalTrials.gov Identifier: NCT01970202
Recruitment Status : Unknown
Verified October 2013 by Nachum vaisman, Prof, Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : October 28, 2013
Last Update Posted : October 28, 2013
Sponsor:
Information provided by (Responsible Party):
Nachum vaisman, Prof, Tel-Aviv Sourasky Medical Center

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Obesity Drug: 40mg Enoxaparin Drug: 60mg Enoxaparin Other: Control Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparing the Efficacy of Two Frequently Used Doses of Enoxaparin for VTE Prophylaxis After Bariatric Surgery
Study Start Date : November 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : July 2016

Arm Intervention/treatment
Active Comparator: 40mg Enoxaparin
Patients with obesity undergoing laparoscopic sleeve gastrectomy, will receive 40mg Enoxaparin per day for 3 days after surgery by subcutaneous administration.
Drug: 40mg Enoxaparin
Patients with obesity undergoing laparoscopic sleeve gastrectomy, will receive 40mg Enoxaparin per day for 3 days after surgery by subcutaneous administration.
Other Name: clexane

Active Comparator: 60mg Enoxaparin
Patients with obesity undergoing laparoscopic sleeve gastrectomy, will receive 60mg Enoxaparin per day for 3 days after surgery by subcutaneous administration.
Drug: 60mg Enoxaparin
Patients with obesity undergoing laparoscopic sleeve gastrectomy, will receive 60mg Enoxaparin per day for 3 days after surgery by subcutaneous administration.
Other Name: clexane

Control
no treatment
Other: Control
no treatment




Primary Outcome Measures :
  1. Anti-factor Xa plasma levels [ Time Frame: within 3 days after surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01970202


Contacts
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Contact: Guy Lahat, MD 972527360237 guyla@tlvmc.gov.il

Locations
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Israel
Tel Aviv Sourasky medical center
Tel Aviv, Israel
Contact: Guy Lahat, MD    972527360237    guyla@tlvmc.gov.il   
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
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Principal Investigator: Guy Lahat, MD Tel-Aviv Sourasky Medical Center

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Responsible Party: Nachum vaisman, Prof, Principle investigator, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01970202    
Other Study ID Numbers: TASMC-13-GL-0241-CTIL
First Posted: October 28, 2013    Key Record Dates
Last Update Posted: October 28, 2013
Last Verified: October 2013
Keywords provided by Nachum vaisman, Prof, Tel-Aviv Sourasky Medical Center:
obesity
overweight
sleeve gastrectomy
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Enoxaparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action