Profylaxis of venous thromboembolism after bariatric surgery.

Conditions: patients
perioperative in bariatric surgery
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

Registration Number: EUCTR2012-002816-19-NL

Lead Sponsor: Rijnstate Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

approval for Roux-en-Y gastric bypass
total body weight > 140 kg
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

renal impairment (GFR < 30ml/min and/ or serum creatinin > 150 micromol/ml)

Coagulation disorders (APTT/PT > 2x norm)

Use of vitamin K antagonists (such as acenocoumarol)

pregnancy

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: Correlation between other body parameters (such as BMI/ total body weight ) and anti-Xa activity<br><br>Determination of dosage linearity of anti-Xa activity of nadroparin in morbid obese patients;Primary end point(s): anti-Xa activity 4 hours after subcutaneous administration of 5700 IU nadroparin;Timepoint(s) of evaluation of this end point: 3 days and 6 weeks after surgery;Main Objective: prospective evaluation of the ralationship between lean body weight and anti-Xa activity and 5700 IE nadroparin 4 hours after subcutaneous administration in morbidly obese patients after bariatric surgery

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): dosage linearity of nadroparin;Timepoint(s) of evaluation of this end point: dosage linearity of nadroparin 2850 IU before surgery and nadrparin 5700 IU after surgery