Efficacy, Safety and Pharmacokinetics of Tinzaparin During Slow Low Efficient Daily Dialysis in Intensive Care Patients

R18098M

This study evaluates the pharmacokinetics of tinzaparin during renal replacement therapy (RRT). 60 patients with clinical indication for pharmacological thromboprophylaxis and slow low efficient daily dialysis (SLEDD) will be studied in Tampere University Hospital. All subjects will receive a 4500 IU bolus of tinzaparin. The subjects in study group (n=30) will also receive a 4500 IU continuous infusion of tinzaparin.

2018-12-03

2025-12-31

2025-12-31

Recruiting

Early phase I

60

Inclusion Criteria: * Critically ill patients requiring intensive care * Indication for pharmacological thromboprophylaxis * Written informed consent obtained from the patient or his/her legal representative * Indication for SLEDD, any of following: * serum creatinine concentration of more than 354 micromol/l or greater than 3 times the baseline creatinine level OR * anuria (urine output of 100 ml/day) for more than 12 hours OR * oliguria: below 0.3 ml/kg/h for more than 24 hours OR 500 ml/day * the presence of clinically significant organ edema (e.g., pulmonary edema, elevated intra-abdominal pressure, significant peripheral swelling) together with oliguria or anuria * Dialysis dependence after continuous renal replacement treatment Exclusion Criteria: * Other indications for anticoagulant therapy than thromboprophylaxis (including sodium citrate for CRRT) * Any long-term anticoagulant or antithrombotic medication, except for low-dose aspirin (\<150 mg daily) * Treatment with tinzaparin or any other LMWH or heparin within 24 hours of study inclusion * Known heparin induced thrombocytopenia (HIT), or hypersensitivity to tinzaparin or any other heparin * Known pregnancy

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

2023-11-22