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Prophylaxis of Venous Thromboembolism After Bariatric Surgery

Information source: Rijnstate Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Morbid Obesity; Thromboembolism; Bypass Complications

Intervention: Nadroparin (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Rijnstate Hospital

Official(s) and/or principal investigator(s):
F.J. Berends, MD, PhD, Principal Investigator, Affiliation: Rijnstate Hospital

Overall contact:
Wendy Schijns, MD, Phone: +31 88 005 8888, Email: wschijns@rijnstate.nl


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.

Clinical Details

Official title: Prospective, Pharmacokinetic Study for Determination of the Relationship Between Lean Body Weight and Anti-Xa Activity 4 Hours After Subcutaneous Injection of 5700 IU Nadroparin in Morbidly Obese Patients After Bariatric Surgery.

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

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

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


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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 and Contacts

Wendy Schijns, MD, Phone: +31 88 005 8888, Email: wschijns@rijnstate.nl

Rijnstate Hospital, Arnhem, Wagnerlaan 55 6800 TA, Netherlands; Recruiting
Wendy Schijns, MD, Phone: +31 88 005 888, Email: wschijns@rijnstate.nl
F.J. Berends, MD, PhD, Principal Investigator
Additional Information

Starting date: March 2013
Last updated: November 19, 2014

Page last updated: August 20, 2015

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