Prophylaxis of Venous Thromboembolism After Bariatric Surgery

Rijnstate Hospital50 enrolled

Overview

This study is a prospective evaluation of the relationship between lean body weight and anti-Xa activity and 5700 International Units (IU) nadroparin 4 hours after subcutaneous administration in morbidly obese patients after bariatric surgery.

There is no guideline for postoperative thromboembolic prevention in morbidly obese patients. The investigators goal is to examine which dose of nadroparin is effective.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Morbid Obesity Thromboembolism Bypass Complications

Interventions

NadroparinDRUG

Patients receive before surgery 3 days 2850 IU nadroparin. anti-Xa levels will be measured. After surgery they receive 5700 IU for 4 weeks as standard care in our hospital. 3 days and 4 weeks after surgery anti-Xa levels will be measured again.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Approval for Roux-en-Y gastric bypass * Total body weight \> 140 kg Exclusion Criteria: * Renal impairment (GFR \< 30ml/min and/ or serum creatinin \> 150 micromol/ml) * Coagulation disorders * Use of vitamin K antagonists (such as acenocoumarol) pregnancy

Locations (1)

Rijnstate Hospital

Arnhem, Wagnerlaan 55, Netherlands

RECRUITING

Outcomes

Primary Outcomes

anti-Xa activity 4 hours after subcutaneous administration of 5700 IU nadroparin

Time frame: 4 hours

Central Contacts

Wendy Schijns, MD

CONTACT

+31 88 005 8888 wschijns@rijnstate.nl

Data from ClinicalTrials.gov

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