venous thromboembolism MedDRA version: 17.0 Level: LLT Classification code 10049909 Term: Venous thromboembolism prophylaxis System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Klexane®
Pharmaceutical Form: Injection
INN or Proposed INN: Enoxaparin sodium
CAS Number: 9005-49-6
Other descriptive name: ENOXAPARIN
Concentration unit: mg milligram(s)
Concentration ty
Sponsors
Odense University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To reduce the incidence of venous thromboembolism(VTE) among patients on continuous renal replacement therapy (CRRT) by using 1 mg/kg enoxaparin, versus the standard dose of 40 mg enoxaparin.;Secondary Objective: To show that falling neutrophil gelatinase-associated lipocalin (NGAL) levels and urine volumes > 200 ml are predictive of renal recovery. In addition to examine the difference in anti-Xa activity, LOS, ventilator free days, bleeding, mortality, filter lifespan, and incidence of other venous thrombosis and HIT between the 2 groups.;Primary end point(s): The primary outcome is the occurrence of proximal leg deep-vein thrombosis(DVT) detected on =3 days after randomization; or pulmonary embolus(PE) diagnosed on computed tomography (CT) of the chest or at autopsy.;Timepoint(s) of evaluation of this end point: All patients will be assessed daily for clinical signs of VTE. Bilateral proximal leg venous compression ultrasound (CUS)will be conducted on the 1st,3rd and 7th day of inclusion. CUS will then be repeated on a weekly basis, or if DVT is clinically suspected. CT chest and echocardiography will only be performed on clinical suspicion of PE. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary outcomes include all other DVT, anti-Xa activity, bleeding(major and minor), filter lifespan, heparin-induced thrombocytopenia (HIT), length of stay on the intensive care unit, hospital length of stay, ventilator days, and death. We will monitor NGAL levels to determine whether NGAL can be used as a prognostic factor for renal recovery.;Timepoint(s) of evaluation of this end point: All patients will be assessed daily for clinical signs of bleeding or VTE. Baseline anti-Xa levels will be measured. Peak and trough anti-Xa levels will be measured on day 3 and thereafter once per week. NGAL will be measured at baseline, and again during CRRT-free intervals. | — |
Countries
Denmark
Contacts
Public ContactOdense University Hospital
Odense University Hospital
Outcome results
None listed