Prospective study into the relation between bodyweight en the effect of thrombosis prophylaxis in patients admitted to hospital

Phase 4

Recruiting

Conditions: deep vein thrombosis
venous thromboembolism
10014523

Registration Number: NL-OMON48903

Lead Sponsor: Diakonessenhuis Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 220

Inclusion Criteria

admission to the hospital for at least 1 night
indication for nadroparine 2850 IE prophylaxis
age > 18 years
signed informed consent

Exclusion Criteria

presence of deep venous thrombosis or pulmonary embolism
use of Vitamin K antagonist or DOAC
trombocytes < 50 10*9/L
any other contra-indication for nadroparine 2850 IE

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Determinants:<br /><br>1. Body weight will be expressed as lean body weight (measured with an<br /><br>impedance-measurement), BMI and the absolute body weight in kilograms. This<br /><br>will be analyzed continously as well as in categories of <50kg; 50-100kg; and<br /><br>>100kg.<br /><br>2. Kidney function will be expressed as the creatinine clearance in<br /><br>ml/min/1.73m2 calculated with the CKD-EPI en Cockcroft and Gault formulas.<br /><br><br /><br><br /><br>Primaire outcome:<br /><br>Anti-Xa levels 4 hours after administration of a standard prophylactic dose of<br /><br>nadroparin 2850 IE .</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Anti-Xa levels <0.2 IU/ml or >0.5 IU/ml (=outside prophylactic range).<br /><br>2. Anti-Xa levels 4 days after administration of the standard nadroparin dose<br /><br>of 2850 IE in 4 subgroups i.e. bodyweight<50kg; >150kg; creatinine clearance<br /><br>30-60 ml/min/1.73m2; and <30 ml/min/1.73m2.<br /><br>3. Any occurence of deep venous thrombosis, pumonary embolism or bleeding<br /><br>within 8 weeks after nadroparine 2850 IE administration. </p><br>