Clinical Drug Trial: Efficacy, safety and pharmacokinetics of tinzaparin during Slow Low Efficient Daily Dialysis in Intensive Care Patients

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-001774-23-FI

Enrollment

Registered

2018-07-04

Start date

2018-07-19

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with clinical indication for pharmacological thromboprophylaxis and slow low efficient daily dialysis (SLEDD).

Interventions

Trade Name: Innohep Product Name: Innohep Pharmaceutical Form: Injection Other descriptive name: TINZAPARIN Concentration unit: IU international unit(s) Concentration type: equal Concentration number:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Age over 18 years • 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: - AKI stage 3 of KDIGO (20): serum creatinine concentration of more than 354 umol/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: =65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the pharmacokinetics of tinzaparin during SLEDD by comparing plasma anti-FXa levels when tinzaparin is administered into the inlet line of hemodialysis circuit after 5 minutes from the start of dialysis either as a single bolus or as a bolus and continuous infusion. The primary outcome measure will be plasma anti-FXa concentration at 4 hours from the onset of SLEDD;Secondary Objective: To evaluate the dialyzer circuit performance ;Primary end point(s): The primary outcome measure is plasma anti-FXa concentration at 4 hours from the onset of SLEDD.;Timepoint(s) of evaluation of this end point: at 4 hours from the onset of SLEDD.	—

Measure

Time frame

Main Objective: To evaluate the pharmacokinetics of tinzaparin during SLEDD by comparing plasma anti-FXa levels when tinzaparin is administered into the inlet line of hemodialysis circuit after 5 minutes from the start of dialysis either as a single bolus or as a bolus and continuous infusion. The primary outcome measure will be plasma anti-FXa concentration at 4 hours from the onset of SLEDD;Secondary Objective: To evaluate the dialyzer circuit performance ;Primary end point(s): The primary outcome measure is plasma anti-FXa concentration at 4 hours from the onset of SLEDD.;Timepoint(s) of evaluation of this end point: at 4 hours from the onset of SLEDD.

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Secondary

Measure	Time frame
Secondary end point(s): Blood samples - Routine blood test (i.e. blood counts, INR, renal parameters, creatinine, C reactive protein and bilirubin) - Anti-FXa - Frozen blood samples : Thrombin generation (CAT) AT 3, FIDD, F1 and F2, TAT, TFPI - At the end of the SLEDD dialysis visual clotting will be evaluated (clotting score) - During SLEDD following parameters will be registered: Transmembrane pressure Inlet pressure Outlet pressure - Total duration of SLEDD - Following adverse events will be registered and treated according to normal practice ;Timepoint(s) of evaluation of this end point: - Routine blood test before SLEDD treatment - Anti-FXa will be measured at 0, 4 (Tmax), 8 and 24 hours from the onset of the SLEDD - Frozen blood samples will be collected at 0, 4, 8 and 24 hours from the onset of the SLEDD Clinical events - At the end of the SLEDD dialysis visual clotting will be evaluated - During SLEDD following parameters will be registered at 1, 2, 4 and 8 hours: o Transmembrane pressure o Inlet pressure o Outlet pressure	—

Measure

Time frame

Secondary end point(s): Blood samples - Routine blood test (i.e. blood counts, INR, renal parameters, creatinine, C reactive protein and bilirubin) - Anti-FXa - Frozen blood samples : Thrombin generation (CAT) AT 3, FIDD, F1 and F2, TAT, TFPI - At the end of the SLEDD dialysis visual clotting will be evaluated (clotting score) - During SLEDD following parameters will be registered: Transmembrane pressure Inlet pressure Outlet pressure - Total duration of SLEDD - Following adverse events will be registered and treated according to normal practice ;Timepoint(s) of evaluation of this end point: - Routine blood test before SLEDD treatment - Anti-FXa will be measured at 0, 4 (Tmax), 8 and 24 hours from the onset of the SLEDD - Frozen blood samples will be collected at 0, 4, 8 and 24 hours from the onset of the SLEDD Clinical events - At the end of the SLEDD dialysis visual clotting will be evaluated - During SLEDD following parameters will be registered at 1, 2, 4 and 8 hours: o Transmembrane pressure o Inlet pressure o Outlet pressure

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Countries

Finland

Contacts

Public ContactDepartment of Intensive Care

Tampere university hospital

anne.kuitunen@pshp.fi

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026