Anti Xa Levels Under Two Different Regimens of Enoxaparin VTE Prophylaxis After Sleeve Gastrectomy for Morbid Obesity
Information source: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obesity
Intervention: 40mg Enoxaparin (Drug); 60mg Enoxaparin (Drug); Control (Other)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Tel-Aviv Sourasky Medical Center Official(s) and/or principal investigator(s): Guy Lahat, MD, Principal Investigator, Affiliation: Tel-Aviv Sourasky Medical Center
Overall contact: Guy Lahat, MD, Phone: 972527360237, Email: guyla@tlvmc.gov.il
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.
Clinical Details
Official title: Comparing the Efficacy of Two Frequently Used Doses of Enoxaparin for VTE Prophylaxis After Bariatric Surgery
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Anti-factor Xa plasma levels
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Guy Lahat, MD, Phone: 972527360237, Email: guyla@tlvmc.gov.il
Tel Aviv Sourasky medical center, Tel Aviv, Israel; Not yet recruiting Guy Lahat, MD, Phone: 972527360237, Email: guyla@tlvmc.gov.il
Additional Information
Starting date: November 2013
Last updated: October 22, 2013
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