Liver TransplantationPhase 4TRAILERNCT04475887
Treatment of Anemia With Intravenous Iron in Patients Listed for Orthotopic Liver Transplantation
A Phase 4 study testing Iron Carboxymaltose in people with Liver Transplantation and Blood Loss, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The aim of this study is to investigate whether therapy with intravenous iron carboxymaltose in patients with iron deficiency anemia (IDA) listed for orthotopic liver transplantation (OLT) increases hemoglobin concentrations and reduces intraoperative transfusion of packed red blood cells (PRBCs). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation, Blood Loss
- What is being tested?
- Iron Carboxymaltose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteAustria
- Study dates
- 23 Jul 2020to 31 May 2023
- 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
- patients listed for OLT with positive screening for IDA
Who cannot join
- Age <18 years
- Hemochromatosis
- Iron utilization disorders
- Non-IDA
- Therapy with erythropoietin-stimulating agents or intravenous iron within 4 weeks prior to screening
- Previous allergic reactions against intravenous iron formulations
Show all 12Show fewer
- Transfusion within 2 weeks prior to screening
- Complete portal vein thrombosis
- High-urgency OLT
- Pregnancy
- Sepsis or severe infection
- Immunosuppressive therapy
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna, Department of Surgery
Vienna, 1090
Georg Gyoeri, MD, +43140400 ext. 68700, georg.gyoeri@meduniwien.ac.at
Andreas Rosenstingl, +43140400 ext. 68730, Andreas.rosenstingl@meduniwien.ac.at
About this study
The aim of this study is to investigate whether therapy with intravenous iron carboxymaltose in patients with iron deficiency anemia (IDA) listed for orthotopic liver transplantation (OLT) increases hemoglobin concentrations and reduces intraoperative transfusion of packed red blood cells (PRBCs). The investigators hypothesize that therapy with intravenous iron will increase hemoglobin concentrations and reduce intraoperative transfusion of PRBCs in patients with IDA listed for OLT.
- Conditions
- Liver Transplantation, Blood Loss
- Being tested
- Iron Carboxymaltose, Placebo
- Keywords
- liver, anemia, transplantation
- Medical subject headings
- Hemorrhage, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron CarboxymaltoseDrug
Also called IRON
see above
PlaceboDrug
see above
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | IV administration of iron-III-carboxymaltose according to iron deficit every 4 weeks. Receives: Drug: Iron Carboxymaltose |
| Group B | Placebo comparator | IV administration of 1000ml 0.9% NaCl every 4 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin at OLT
Change in hemoglobin concentrations from baseline until before induction of anesthesia for OLT
Measured: 6 months
Secondary outcomes (2)
Transfusion requirement
Transfusion of PRBCs during and within the first 24 hours following OLT
Measured: 6 months
Hemoglobin after 4 weeks
Change in hemoglobin concentrations from baseline until 4 weeks after initiation of therapy
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start23 Jul 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georg Gyoeri, Medical University of Vienna
- Investigators
- Georg P Gyoeri, MD, Principal investigator, Department of SurgeryDavid M Baron, MD, Principal investigator, Department of Anaesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04475887
- Sponsor's protocol ID
- 1175/2017
- Acronym
- TRAILER
- Status last verified
- Jul 2020
- First submitted
- 14 Jul 2020
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Anemia With Intravenous Iron in Patients Listed for Orthotopic Liver Transplantation
- ClinicalTrials.gov ID
- NCT04475887
- Acronym / sponsor ID
- TRAILER / 1175/2017
- Conditions
- Liver Transplantation, Blood Loss
- Keywords
- liver, anemia, transplantation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 23 Jul 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 17 Jul 2020 (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.
The aim of this study is to investigate whether therapy with intravenous iron carboxymaltose in patients with iron deficiency anemia (IDA) listed for orthotopic liver transplantation (OLT) increases hemoglobin concentrations and reduces intraoperative transfusion of packed red blood cells (PRBCs). The investigators hypothesize that therapy with intravenous iron will increase hemoglobin concentrations and reduce intraoperative transfusion of PRBCs in patients with IDA listed for OLT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Iron CarboxymaltoseIV administration of iron-III-carboxymaltose according to iron deficit every 4 weeks. |
| Group B | Placebo comparator | Drug: PlaceboIV administration of 1000ml 0.9% NaCl every 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients listed for OLT with positive screening for IDA
Key exclusion criteria (12 listed)
- Age <18 years
- Hemochromatosis
- Iron utilization disorders
- Non-IDA
- Therapy with erythropoietin-stimulating agents or intravenous iron within 4 weeks prior to screening
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 |
|---|---|---|
| Iron CarboxymaltoseAlso: IRONsee above | Drug | Group A |
| Placebosee above | Drug | Group B |
Primary outcome
Hemoglobin at OLT
Time frame: 6 months
Change in hemoglobin concentrations from baseline until before induction of anesthesia for OLT
2 secondary outcomes
Transfusion requirement
Time frame: 6 months
Hemoglobin after 4 weeks
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- 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.
Georg P Gyoeri, MD principal investigator
Department of Surgery
David M Baron, MD principal investigator
Department of Anaesthesiology
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 Iron Carboxymaltose in people with Liver Transplantation and Blood Loss, run by Medical University of Vienna at 1 site in Austria.
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 1 inclusion and 12 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 28 Jul 2020. 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 Austria. 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. Some participants in this study may receive a placebo. 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 Georg P Gyoeri, MD (+43140400 ext. 68700, georg.gyoeri@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin at OLT (time frame: 6 months). 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 28 Jul 2020.