Prevention of blood clots in patients with acute kidney injury

• Conditions: venous thromboembolism; MedDRA version: 17.0Level: LLTClassification code 10049909Term: Venous thromboembolism prophylaxisSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2012-004368-23-DK
• Lead Sponsor: Odense University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-25
• Last Update Posted: 30 March 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients who develop acute kidney injury, and who need CRRT
Weight 45 - 150 kg
Age =18 years
Informed consent
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 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 186

Exclusion Criteria

Major trauma
Need for therapeutic anticoagulation
Contraindication to heparin(allergy, HIT)
Pregnancy
Life-support limitation
Uncontrolled hypertension(bp > 180/110) i =12 timer
Cerebral haemorrhage , acute gastrointestinal bleeding
Severe thrombocytopenia (platelet count <50 × 109/l)
International Normalized Ratio or activated partial thromboplastin time =2 times the upper limit of normal
Chronic renal failure, or acute-on-chronic

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified