Blood Platelet TransfusionPhase 4FiT2012NCT01955811
Study to Reveal if Fibrinogen Treatment Effects Blood Clotting Better Than a Platelet Transfusion
A Phase 4 study testing Administration of platelet concentrate and taking blood samples in people with Blood Platelet Transfusion and Blood Clotting, run by Medical University Innsbruck at 5 sites in 2 countries.
Trial summary
Patients with need of platelet transfusion for any reason will participate in this study. Directly before the start of infusion and one hour after the end of platelet transfusion blood samples will be drawn and treated with different concentrations of Fibrinogen (a blood clotting factor) in-vitro. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Blood Platelet Transfusion, Blood Clotting
- What is being tested?
- Administration of platelet concentrate and taking blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Dec 2012to Aug 2014
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient with the clinical need for platelet transfusion
- age: 18 - 85 years
Who cannot join
- pregnant or nursing women
- patients who disagree to participate in the study
- for emergency patients: patients with known refusal of a participation in this clinical trial
- active participation in a clinical trial
- any condition, including the presence of laboratory abnormalities, which would place confound in the ability to interpret data from the study
- any serious medical condition, laboratory abnormalities, or psychiatric illness, that would prevent the subject from signing the informed consent form
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Austria3 sites
Central Institution for Blood Transfution and Immunology
Innsbruck, Tyrol, 6020
Department for Anesthesia and Intensive Care Medicine
Innsbruck, Tyrol, 6020
General and Surgical Intensive Care Medicine
Innsbruck, Tyrol, 6020
Denmark2 sites
Faculty of Health Sciences, Centre for Haemophilia and Thrombosis, Aarhus University Hospital
Aarhus, Skejby, 8200
Faculty of Health Sciences, Department for Anaesthesia and Critical Care Medicine
Aarhus, Skejby, 8200
About this study
Official title: Bicentric Clinical Trial With in Vitro Experiments to Assess the Effect of Fibrinogen (FGTW) on Coagulation in Thrombocytopenia
Patients with need of platelet transfusion for any reason will participate in this study. Directly before the start of infusion and one hour after the end of platelet transfusion blood samples will be drawn and treated with different concentrations of Fibrinogen (a blood clotting factor) in-vitro. Blood samples with and without Fibrinogen/platelet transfusion will be compared. The study hypothesis is that treatment with Fibrinogen results in a better stabilisation of blood coagulation.
Read the detailed description
In total 300 patients with the need of platelet transfusion for whatever reason will be included when meeting the inclusion- and exclusion criteria.
For all patients three visits are planned, where blood samples will be taken. The first blood samples will be taken directly before the start of platelet transfusion, the second 1 hour after the end of the platelet transfusion and the third after 24 hours.
Untreated citrate and EDTA blood samples from Visit 1 will be serving as baseline for the coagulation testing. Further citrate blood samples from the first visit will be spiked with different concentrations of fibrinogen in vitro. Untreated citrate and EDTA blood samples will be taken 1 hour and 24 hours after platelet transfusion for comparison. Further citrate blood samples will be spiked with different concentrations of fibrinogen in vitro again 1 hour after platelet transfusion. In addition, randomly chosen samples will be analyzed using confocal microscopy. Routine coagulation analysis include activated partial thromboplastin time (aPTT), prothrombin time(PT), fibrinogen, blood coagulation factor thirteen (FXIII), thromboelastometry (ExTEM \& FibTEM) before and after platelet transfusion.
- Conditions
- Blood Platelet Transfusion, Blood Clotting
- Being tested
- Administration of platelet concentrate and taking blood samples
- Keywords
- platelet transfusion, Fibrinogen, blood coagulation, Thrombocytopenia, in-vitro experiments, FGTW, Fit2012, factor I, Fibrin
- Medical subject headings
- Thrombosis, Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of platelet concentrate and taking blood samplesDrug
Patient with the need of a platelet transfusion, will have 4 intervention points. 1. directly before the start of the transfusion a blood sample will be drawn. 2. Patient receives the platelet transfusion. 3. One hour after the end of transfusion a second blood sample will be drawn. 4. 24 h after the end of the platelet transfusion a further bloos sample will be collected. The first two samples will be (beside blood cell counts) spiked in-vitro with different amounts of Human fibrinogen and blood clotting tests will be performed. The same with the 3. blood sample, but without spiking steps.
| Study group | Role | What they receive |
|---|---|---|
| Platelet concentrate transfusion and Human Fibrinogen | Other | Blood samples will be collected directly before the start of transfusion and 1 hour after the end of transfusion. These samples will be spiked with Human Fibrinogen and clotting tests will be performed. After 24 h after end of transfusion a clotting test will be performed again. Receives: Drug: Administration of platelet concentrate and taking blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in A30 (ExTEM®) between blood samples after in vitro spiking and compared to those blood samples obtained from the same patients after platelet transfusion
Measured: 1 hour after platelet transfusion
Secondary outcomes (3)
Assessment of the difference in the response profile of Blood cell count (EDTA blood sample)
Measured: before and 1 hour after platelet transfusion
Standard coagulation tests as aPTT, PT, fibrinogen and FXIII
Measured: before and 1 hour after platelet transfusion
Further bleeding management system(ROTEM®)parameters
maximum clot firmness(MCF) clotting time(CT) clot formation time (CFT) lysis index 30 minutes after CT (L30)
Measured: before and one hour after platelet transfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startDec 2012
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Platelet TransfusionStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dietmar Fries, M.D., Medical University Innsbruck
- Investigators
- Dietmar Fries, Univ-Prof.Dr, Principal investigator, General and Surgical Intensive Care Medicine, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01955811
- Sponsor's protocol ID
- FiT2012
- Acronym
- FiT2012
- Status last verified
- Mar 2016
- First submitted
- 2 Sep 2013
- Last updated
- 23 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bicentric Clinical Trial With in Vitro Experiments to Assess the Effect of Fibrinogen (FGTW) on Coagulation in Thrombocytopenia
- ClinicalTrials.gov ID
- NCT01955811
- Acronym / sponsor ID
- FiT2012 / FiT2012
- Conditions
- Blood Platelet Transfusion, Blood Clotting
- Keywords
- platelet transfusion, Fibrinogen, blood coagulation, Thrombocytopenia, in-vitro experiments, FGTW, Fit2012, factor I
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 8 Oct 2013 (estimated)
- 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.
Patients with need of platelet transfusion for any reason will participate in this study. Directly before the start of infusion and one hour after the end of platelet transfusion blood samples will be drawn and treated with different concentrations of Fibrinogen (a blood clotting factor) in-vitro. Blood samples with and without Fibrinogen/platelet transfusion will be compared. The study hypothesis is that treatment with Fibrinogen results in a better stabilisation of blood coagulation.
Detailed description
In total 300 patients with the need of platelet transfusion for whatever reason will be included when meeting the inclusion- and exclusion criteria.
For all patients three visits are planned, where blood samples will be taken. The first blood samples will be taken directly before the start of platelet transfusion, the second 1 hour after the end of the platelet transfusion and the third after 24 hours.
Untreated citrate and EDTA blood samples from Visit 1 will be serving as baseline for the coagulation testing. Further citrate blood samples from the first visit will be spiked with different concentrations of fibrinogen in vitro. Untreated citrate and EDTA blood samples will be taken 1 hour and 24 hours after platelet transfusion for comparison. Further citrate blood samples will be spiked with different concentrations of fibrinogen in vitro again 1 hour after platelet transfusion. In addition, randomly chosen samples will be analyzed using confocal microscopy. Routine coagulation analysis include activated partial thromboplastin time (aPTT), prothrombin time(PT), fibrinogen, blood coagulation factor thirteen (FXIII), thromboelastometry (ExTEM \& FibTEM) before and after platelet transfusion.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Platelet concentrate transfusion and Human Fibrinogen | Other | Drug: Administration of platelet concentrate and taking blood samplesBlood samples will be collected directly before the start of transfusion and 1 hour after the end of transfusion. These samples will be spiked with Human Fibrinogen and clotting tests will be performed. After 24 h after end of transfusion a clotting test will be performed again. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patient with the clinical need for platelet transfusion
- age: 18 - 85 years
Key exclusion criteria (6 listed)
- pregnant or nursing women
- patients who disagree to participate in the study
- active participation in a clinical trial
- any condition, including the presence of laboratory abnormalities, which would place confound in the ability to interpret data from the study
- any serious medical condition, laboratory abnormalities, or psychiatric illness, that would prevent the subject from signing the informed consent form
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 |
|---|---|---|
| Administration of platelet concentrate and taking blood samplesPatient with the need of a platelet transfusion, will have 4 intervention points. 1. directly before the start of the transfusion a blood sample will be drawn. 2. Patient receives the platelet transfusion. 3. One hour after the end of transfusion a second blood sample will be drawn. 4. 24 h after the end of the platelet transfusion a further bloos sample will be collected. The first two samples will be (beside blood cell counts) spiked in-vitro with different amounts of Human fibrinogen and blood clotting tests will be performed. The same with the 3. blood sample, but without spiking steps. | Drug | Platelet concentrate transfusion and Human Fibrinogen |
Primary outcome
difference in A30 (ExTEM®) between blood samples after in vitro spiking and compared to those blood samples obtained from the same patients after platelet transfusion
Time frame: 1 hour after platelet transfusion
3 secondary outcomes
Assessment of the difference in the response profile of Blood cell count (EDTA blood sample)
Time frame: before and 1 hour after platelet transfusion
Standard coagulation tests as aPTT, PT, fibrinogen and FXIII
Time frame: before and 1 hour after platelet transfusion
Further bleeding management system(ROTEM®)parameters
Time frame: before and one hour after platelet transfusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2016.
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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.
Dietmar Fries, Univ-Prof.Dr principal investigator
General and Surgical Intensive Care Medicine, Medical University Innsbruck
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Administration of platelet concentrate and taking blood samples in people with Blood Platelet Transfusion and Blood Clotting, run by Medical University Innsbruck at 5 sites in 2 countries.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 23 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Austria, Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference in A30 (ExTEM®) between blood samples after in vitro spiking and compared to those blood samples obtained from the same patients after platelet transfusion (time frame: 1 hour after platelet transfusion). 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 23 Mar 2016.