Prospective, pharmacokinetic study for determination of the relationship between lean body weight and anti-Xa activity 4 hours after subcutaneous administration of 5700 IU nadroparin in morbidly obese patients after bariatric surgery.
Phase 4
Completed
- Conditions
- antistolling profylaxe bij bariatrische chirurgiemorbid obesityprofylaxis thrombosis
- Registration Number
- NL-OMON37098
- Lead Sponsor
- Rijnstate Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
approval for Roux-en-Y gastric bypass
body weight of > 140 kg
Exclusion Criteria
renal impairment (GFR < 30 and/or serum creatinin > 150)
Anticoagulation disorders (PT/APT > 2x norm)
Use of oral anticoagulation (such as acenocoumarol)
pregnancy
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>anti-Xa activity 4 hours after subcutaneous administration of 5700 IU<br /><br>nadroparin</p><br>
- Secondary Outcome Measures
Name Time Method <p>dosage linearity of nadroparin (between 2850 IU and nadrparin 5700 IU)</p><br>