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

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

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON48903

Enrollment

220

Registered

2018-10-22

Start date

2018-11-05

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

deep vein thrombosis venous thromboembolism

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: presence of deep venous thrombosis or pulmonary embolism use of Vitamin K antagonist or DOAC trombocytes

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

Measure	Time frame
1. Anti-Xa levels 0.5 IU/ml (=outside prophylactic range). 2. Anti-Xa levels 4 days after administration of the standard nadroparin dose of 2850 IE in 4 subgroups i.e. bodyweight150kg; creatinine clearance 30-60 ml/min/1.73m2; and	—

Countries

Netherlands

Outcome results