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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    60
  • sponsor
    Tampere University Hospital
Updated on 27 January 2021
critical illness
renal replacement
replacement therapy
oliguria
dialysis
urine output
renal replacement therapy

Summary

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.

Description

After written informed consent, 60 subjects with clinical indication for pharmacological thromboprophylaxis and SLEDD will be studied in the Tampere University Hospital intensive care unit. After inclusion the subjects will be randomly assigned into study group (30 patients) and control (30 patients).

All subjects receive a bolus of tinzaparin 4500 IU into the inlet line of dialyzer at 5 minutes after the start of blood pump. Afterwards the subjects in the study group will continue to receive continuous tinzaparin infusion (concentration 100 IU/ml) 500 IU/h over seven hours. No other heparin product (including arteria flush lines) nor dilution fluids at the dialyzer are allowed during the study period of 24 hours. Each SLEDD treatment will be performed with Cordiax 5008S (Fresenius) for 8 hours. After the study period of 24 hours thromboprophylaxis will be prescribed according to the normal practice in the ICU.

The primary outcome measure is plasma anti-FXa concentration at 4 hours from the onset of SLEDD. Plasma Anti-FXa will be drawn at timepoints 0 hours, 4 hours, 8 hours and 24 hours from the onset of the dialysis.

The clotting formation in RRT system will be evaluated by clotting scoring. In the case of serious clotting RRT treatment is stopped and the new RRT is started. The study will end to the new RRT.

Details
Condition Renal Failure, Kidney Failure (Pediatric), Kidney Failure, Renal Failure, Acute renal failure, Anticoagulants, Renal Replacement Therapy, Kidney Failure (Pediatric), Kidney Failure, anticoagulant, blood thinner, agents, anticoagulant, anticoagulation agents, blood thinners, anticoagulant drugs, acute kidney injury, acute kidney injuries
Treatment Tinzaparin continuous infusion, Tinzaparin bolus
Clinical Study IdentifierNCT03614741
SponsorTampere University Hospital
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

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
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