Transfusion-related Acute Lung InjuryNCT01756690
Predicting Lung Injury From Transfusion in Patients With Liver Disease
An observational study of Transfusion-related Acute Lung Injury and Chronic Liver Disease, run by University of Colorado, Denver at 2 sites in United States.
Trial summary
A certain molecule floating in the blood may represent a risk of lung injury after a transfusion. We are determining whether detection of this molecule on a simple blood clotting test will predict the development of lung injury due to transfusion in bleeding patients with chronic liver disease. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Transfusion-related Acute Lung Injury, Chronic Liver Disease, Gastrointestinal Bleeding
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2011to Dec 2016
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with chronic Liver disease admitted to an intensive care unit with a gastrointestinal bleed and INR> 1.5 who may receive plasma transfusion therapy.
Inclusion criteria: Subjects will be eligible to participate in the study if they meet all of the following criteria:
- Admit to an ICU due to gastrointestinal bleeding AND an INR > 1.5
- Patient has chronic liver disease defined as 1 or more of the three following diagnostic criteria:
- Previous diagnosis of chronic liver disease OR Imaging or biopsy diagnosis of cirrhosis
- Signs of portal hypertension (ascites, varices, hypersplenism)
- Laboratory evidence of synthetic dysfunction (INR>1.5, Bilirubin> 2.0, Albumin< 2.5) AND ≥2 physical exam findings on admission associated with chronic liver disease (palmar erythema, spider angiomata, asterixis, caput medusa, gynecomastia)
Exclusion criteria: Subjects will be ineligible to participate in the study if they meet any of the following criteria
- Patient under age 18 OR pregnant OR incarcerated
- Patient meets criteria for acute respiratory distress syndrome (ARDS) (PaO2/FiO2<165)
- Patient admitted to ICU for re-bleed on same hospital admission OR has already received >4 units of plasma.
- History of inheritable or acquired clotting or bleeding disorder
- Patient actively anticoagulated or has recently received (within 72h) vitamin K antagonists, direct thrombin inhibitors, heparins or Xa antagonists
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Colorado Denver, Anshutz medical campus
Aurora, Colorado, 80045
Denver Health and Hospital
Denver, Colorado, 80207
About this study
Official title: Endogenous Heparinoid Interference With Coagulation on Thromboelastogram as a Predictive Biomarker for Transfusion Related Acute Lung Injury (TRALI)
A certain molecule floating in the blood may represent a risk of lung injury after a transfusion. We are determining whether detection of this molecule on a simple blood clotting test will predict the development of lung injury due to transfusion in bleeding patients with chronic liver disease.
- Keywords
- respiratory distress syndrome, adult, blood component transfusion, gastrointestinal hemorrhage, blood coagulation
- Medical subject headings
- Transfusion-Related Acute Lung Injury, Gastrointestinal Hemorrhage, Respiratory Distress Syndrome, Thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
TRALI (consensus definition- with exception of absence of other acute lung injury risk factors)
Measured: 0-54 hours post enrollment
Secondary outcomes (2)
Change in ratio of partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2)
Measured: 0-54 hours post enrollment
Bleeding complications
Baveno V criteria
Measured: 0-5 days post-enrollmnet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2012 (estimated)
- Study startOct 2011
- Primary completionOct 2014
- Study completionDec 2016
Why it stopped: Recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transfusion-related Acute Lung InjuryStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01756690
- Sponsor's protocol ID
- 09-0238
- Status last verified
- Jan 2017
- First submitted
- 20 Dec 2012
- Last updated
- 30 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endogenous Heparinoid Interference With Coagulation on Thromboelastogram as a Predictive Biomarker for Transfusion Related Acute Lung Injury (TRALI)
- ClinicalTrials.gov ID
- NCT01756690
- Acronym / sponsor ID
- 09-0238
- Keywords
- respiratory distress syndrome, adult, blood component transfusion, gastrointestinal hemorrhage, blood coagulation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Recruitment
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 27 Dec 2012 (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.
A certain molecule floating in the blood may represent a risk of lung injury after a transfusion. We are determining whether detection of this molecule on a simple blood clotting test will predict the development of lung injury due to transfusion in bleeding patients with chronic liver disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with chronic Liver disease admitted to an intensive care unit with a gastrointestinal bleed and INR> 1.5 who may receive plasma transfusion therapy.
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
TRALI (consensus definition- with exception of absence of other acute lung injury risk factors)
Time frame: 0-54 hours post enrollment
2 secondary outcomes
Change in ratio of partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2)
Time frame: 0-54 hours post enrollment
Bleeding complications
Time frame: 0-5 days post-enrollmnet
Results and safety
The study was stopped early (reason given: Recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transfusion-related Acute Lung Injury and Chronic Liver Disease, run by University of Colorado, Denver at 2 sites 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?
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: stopped early, as of the sponsor's last update on 30 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: Recruitment). Results are not available in the source record.
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?
TRALI (consensus definition- with exception of absence of other acute lung injury risk factors) (time frame: 0-54 hours post enrollment). 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 30 Jan 2017.