Acute Kidney InjuryPhase 4Tinza-SLEDDNCT03614741
Efficacy, Safety and Pharmacokinetics of Tinzaparin During Slow Low Efficient Daily Dialysis in Intensive Care Patients
A Phase 4 study testing Tinzaparin continuous infusion and Tinzaparin bolus in people with Acute Kidney Injury and Renal Replacement Therapy, run by Tampere University Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Renal Replacement Therapy, Anticoagulants
- What is being tested?
- Tinzaparin continuous infusion and Tinzaparin bolus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFinland
- Study dates
- 3 Dec 2018to 31 Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Tampere University Hospital
Tampere, Pirkanmaa, 33521
Anne Kuitunen, PhD, +358 3 311 65544, anne.kuitunen@pshp.fi
Annukka Vahtera, MD
About this study
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.
Read the detailed 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.
- Being tested
- Tinzaparin continuous infusion, Tinzaparin bolus
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tinzaparin continuous infusionDrug
4500 IU continuous infusion of Tinzaparin
Tinzaparin bolusDrug
4500 IU bolus of Tinzaparin
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Bolus of 4500 IU tinzaparin Receives: Drug: Tinzaparin bolus |
| Study group | Active comparator | Bolus of 4500 IU tinzaparin and continuous infusion of 4500 IU tinzaparin Receives: Drug: Tinzaparin continuous infusion; Drug: Tinzaparin bolus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma anti-FXa concentration
Plasma anti-factor Xa blood sample
Measured: 4 hours from the onset of SLEDD
Secondary outcomes (3)
Plasma anti-FXa concentration
Plasma anti-factor Xa blood sample
Measured: 8 hours from the onset of SLEDD
Plasma anti-FXa concentration
Plasma anti-factor Xa blood sample
Measured: 24 hours from the onset of SLEDD
Clotting Score
Clotting in renal replacement sircuit will be evaluated hourly according to predescribed score
Measured: 8 hours from the onset of SLEDD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start3 Dec 2018
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Kuitunen, MD, PhD, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03614741
- Sponsor's protocol ID
- R18098M
- Acronym
- Tinza-SLEDD
- Status last verified
- Nov 2023
- First submitted
- 30 Jul 2018
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Safety and Pharmacokinetics of Tinzaparin During Slow Low Efficient Daily Dialysis in Intensive Care Patients
- ClinicalTrials.gov ID
- NCT03614741
- Acronym / sponsor ID
- Tinza-SLEDD / R18098M
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 3 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: Tinzaparin bolusBolus of 4500 IU tinzaparin |
| Study group | Active comparator | Drug: Tinzaparin continuous infusion, Drug: Tinzaparin bolusBolus of 4500 IU tinzaparin and continuous infusion of 4500 IU tinzaparin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tinzaparin continuous infusion4500 IU continuous infusion of Tinzaparin | Drug | Study group |
| Tinzaparin bolus4500 IU bolus of Tinzaparin | Drug | Control group, Study group |
Primary outcome
Plasma anti-FXa concentration
Time frame: 4 hours from the onset of SLEDD
Plasma anti-factor Xa blood sample
3 secondary outcomes
Plasma anti-FXa concentration
Time frame: 8 hours from the onset of SLEDD
Plasma anti-FXa concentration
Time frame: 24 hours from the onset of SLEDD
Clotting Score
Time frame: 8 hours from the onset of SLEDD
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Kuitunen, MD, PhD principal investigator
Tampere University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tinzaparin continuous infusion and Tinzaparin bolus in people with Acute Kidney Injury and Renal Replacement Therapy, run by Tampere University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne Kuitunen, MD, PhD (+358331165544, anne.kuitunen@pshp.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma anti-FXa concentration (time frame: 4 hours from the onset of SLEDD). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.