Poor Platelet Transfusion OutcomeNCT02158416
Platelet Products Tested With the ThromboLUX® Platelet Quality Test
An observational study of Poor Platelet Transfusion Outcome, run by LightIntegra Technology at 1 site in United States.
Trial summary
The planned minimal risk study is a blinded study on consecutive transfusable platelet products. The aim of the study is to evaluate the quality of platelet components sampled prior to transfusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Poor Platelet Transfusion Outcome
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Nov 2014
- Phase
- Observational
- 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
Study population: The study population consists of adults who require treatment of a blood cancer with platelet transfusion(s). Patients will be stable and thrombocytopenic, however treatment center will intervene for bleeding. Adult hematology-oncology outpatients.
Who may be able to join
- adult hematology-oncology outpatients
- stable and thrombocytopenic
Who cannot join
- age <18 yrs
- splenomegaly
- unable to provide informed consent
- pregnancy
- acute promyelocytic leukemia
- ITP (Idiopathic thrombocytopenic purpura)
- HUS
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Blinded Study on Consecutive Transfusable Platelet Products Tested With the ThromboLUX® Platelet Quality Test
The planned minimal risk study is a blinded study on consecutive transfusable platelet products. The aim of the study is to evaluate the quality of platelet components sampled prior to transfusion.
The primary patient transfusion outcome in this study is the 1-hour corrected count increment (1 hr CCI), which is a widely accepted clinical outcome measure. Platelet products will be sampled for ThromboLUX testing before being sent from the blood bank to the treatment center. After receipt at the treatment center, the platelet products will be used as per regular clinical practice, and the outcome data from each patient will be collected. At the end of the study, TLX Scores will be compared to the transfusion outcomes to determine if a low TLX Score is associated with a poor transfusion outcome.
During the course of the study, the TLX Score will not be known to the clinicians, or utilized in any way to decide if the platelet product should be transfused.
- Conditions
- Poor Platelet Transfusion Outcome
- Keywords
- platelet, transfusion, ThromboLUX, corrected count increment, thrombocytopenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hematology-oncology | hematology-oncology outpatients requiring platelet transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
TLX Score Correlation with CCI
The value of the ThromboLUX Score (obtained from platelet products with the ThromboLUX platelet quality test system) to predict patient transfusion outcome (measured as 1hr corrected count increment CCI). The correlation between ThromboLUX score and 1hr CCI (study endpoint) will be reported at the end of the study
Measured: Patients are expected to be enrolled for an average of 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study startDec 2013
- Primary completionJul 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poor Platelet Transfusion OutcomeStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- LightIntegra Technology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William A Heaton, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02158416
- Sponsor's protocol ID
- TLXPRO017
- Status last verified
- Mar 2015
- First submitted
- 17 Mar 2014
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blinded Study on Consecutive Transfusable Platelet Products Tested With the ThromboLUX® Platelet Quality Test
- ClinicalTrials.gov ID
- NCT02158416
- Acronym / sponsor ID
- TLXPRO017
- Conditions
- Poor Platelet Transfusion Outcome
- Keywords
- platelet, transfusion, ThromboLUX, corrected count increment, thrombocytopenic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- LightIntegra TechnologyIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 6 Jun 2014 (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.
The planned minimal risk study is a blinded study on consecutive transfusable platelet products. The aim of the study is to evaluate the quality of platelet components sampled prior to transfusion.
The primary patient transfusion outcome in this study is the 1-hour corrected count increment (1 hr CCI), which is a widely accepted clinical outcome measure. Platelet products will be sampled for ThromboLUX testing before being sent from the blood bank to the treatment center. After receipt at the treatment center, the platelet products will be used as per regular clinical practice, and the outcome data from each patient will be collected. At the end of the study, TLX Scores will be compared to the transfusion outcomes to determine if a low TLX Score is associated with a poor transfusion outcome.
During the course of the study, the TLX Score will not be known to the clinicians, or utilized in any way to decide if the platelet product should be transfused.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hematology-oncology | – | –hematology-oncology outpatients requiring platelet transfusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adults who require treatment of a blood cancer with platelet transfusion(s). Patients will be stable and thrombocytopenic, however treatment center will intervene for bleeding. Adult hematology-oncology outpatients.
Key inclusion criteria (2 listed)
- adult hematology-oncology outpatients
- stable and thrombocytopenic
Key exclusion criteria (7 listed)
- age <18 yrs
- splenomegaly
- unable to provide informed consent
- pregnancy
- acute promyelocytic leukemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
TLX Score Correlation with CCI
Time frame: Patients are expected to be enrolled for an average of 6 months.
The value of the ThromboLUX Score (obtained from platelet products with the ThromboLUX platelet quality test system) to predict patient transfusion outcome (measured as 1hr corrected count increment CCI). The correlation between ThromboLUX score and 1hr CCI (study endpoint) will be reported at the end of the study
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 1 Apr 2015.
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.
William A Heaton, MD principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Poor Platelet Transfusion Outcome, run by LightIntegra Technology at 1 site in United States.
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 7 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 1 Apr 2015. 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 United States. 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.
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?
TLX Score Correlation with CCI (time frame: Patients are expected to be enrolled for an average of 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 1 Apr 2015.