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