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

NCT03614741 | Unknown Phase 4

• 1 other identifier: R18098M
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Kidney Injury; Renal Replacement Therapy; Anticoagulants

Outcome Measures

Primary Outcomes (1)

• Plasma anti-FXa concentration

  Plasma anti-factor Xa blood sample

  4 hours from the onset of SLEDD

Secondary Outcomes (3)

• Plasma anti-FXa concentration

  8 hours from the onset of SLEDD

• Plasma anti-FXa concentration

  24 hours from the onset of SLEDD

• Clotting Score

  8 hours from the onset of SLEDD

Study Arms (2)

Control group

ACTIVE COMPARATOR

Bolus of 4500 IU tinzaparin

Drug: Tinzaparin bolus

Study group

ACTIVE COMPARATOR

Bolus of 4500 IU tinzaparin and continuous infusion of 4500 IU tinzaparin

Drug: Tinzaparin continuous infusion; Drug: Tinzaparin bolus

Interventions

Tinzaparin continuous infusion DRUG

4500 IU continuous infusion of Tinzaparin

Study group

Tinzaparin bolus DRUG

4500 IU bolus of Tinzaparin

Control group; Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Known heparin induced thrombocytopenia (HIT), or hypersensitivity to tinzaparin or any other heparin
• Known pregnancy

Sponsors & Collaborators

• Tampere University Hospital: lead

Study Sites (1)

Tampere University Hospital

Tampere, Pirkanmaa, 33521, Finland

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Anne Kuitunen, MD, PhD

  Tampere University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne Kuitunen, MD, PhD

CONTACT

+358331165544; anne.kuitunen@pshp.fi

Simo Varila

CONTACT

+358505128189; simo.varila@pshp.fi

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2018
• First Posted: August 3, 2018
• Study Start: December 3, 2018
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)