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

Launched by TAMPERE UNIVERSITY HOSPITAL · Jul 30, 2018

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called tinzaparin in patients who are critically ill and undergoing a specific type of dialysis known as slow low efficient daily dialysis (SLEDD). The goal is to understand how well the medication works, how safe it is, and how it moves through the body during this treatment. The trial will involve 60 patients at Tampere University Hospital who need protection against blood clots, which can be a concern in intensive care settings. Half of the participants will receive a one-time dose of tinzaparin, while the other half will receive that same dose along with a continuous drip of the medication.

To be eligible for this study, patients must be critically ill, need intensive care, and meet specific conditions related to their kidney function, such as having high creatinine levels or very low urine output. Participants will be monitored closely to ensure their safety and to gather information on how the medication works while they are receiving dialysis. It’s important for potential participants to know that certain health conditions and medications may prevent them from joining the trial, so discussions with the medical team will help determine eligibility.

Gender

ALL

Eligibility criteria

• 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