Evaluating tinzaparin use in dialysis for critically ill patients
Efficacy, Safety and Pharmacokinetics of Tinzaparin During Slow Low Efficient Daily Dialysis in Intensive Care Patients
This study is testing if using tinzaparin helps prevent blood clots in critically ill patients undergoing a specific type of dialysis.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tampere University Hospital Academic / other |
| Locations | 1 site (Tampere, Pirkanmaa) |
| Trial ID | NCT03614741 on ClinicalTrials.gov |
What this trial studies
This study investigates the pharmacokinetics and safety of tinzaparin during slow low efficient daily dialysis (SLEDD) in critically ill patients requiring anticoagulation. A total of 60 patients will be randomly assigned to receive either a bolus of tinzaparin followed by a continuous infusion or just the bolus. The primary outcome is to measure plasma anti-FXa concentration at various time points during the dialysis treatment. The study aims to assess the effectiveness of tinzaparin in preventing clot formation in the renal replacement therapy system.
Who should consider this trial
Good fit: Ideal candidates are critically ill patients requiring intensive care and pharmacological thromboprophylaxis during SLEDD.
Not a fit: Patients with other indications for anticoagulant therapy or those on long-term anticoagulant medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve anticoagulation management in critically ill patients undergoing dialysis, potentially reducing complications related to clotting.
How similar studies have performed: While similar studies on anticoagulation in dialysis exist, this specific approach with tinzaparin during SLEDD is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tampere, Pirkanmaa
- Tampere University Hospital — Tampere, Pirkanmaa, Finland (Recruiting)
Study contacts
- Principal investigator: Anne Kuitunen, MD, PhD — Tampere University Hospital
- Study coordinator: Anne Kuitunen, MD, PhD
- Email: anne.kuitunen@pshp.fi
- Phone: +358331165544
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.