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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01756690
Other study ID # 09-0238
Secondary ID
Status Terminated
Phase N/A
First received December 20, 2012
Last updated January 27, 2017
Start date October 2011
Est. completion date December 2016

Study information

Verified date January 2017
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


Recruitment information / eligibility

Status Terminated
Enrollment 16
Est. completion date December 2016
Est. primary completion date October 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion criteria: Subjects will be eligible to participate in the study if they meet all of the following criteria:

1. Admit to an ICU due to gastrointestinal bleeding AND an INR > 1.5

2. Patient has chronic liver disease defined as 1 or more of the three following diagnostic criteria:

1. Previous diagnosis of chronic liver disease OR Imaging or biopsy diagnosis of cirrhosis

2. Signs of portal hypertension (ascites, varices, hypersplenism)

3. 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

1. Patient under age 18 OR pregnant OR incarcerated

2. Patient meets criteria for acute respiratory distress syndrome (ARDS) (PaO2/FiO2<165)

3. Patient admitted to ICU for re-bleed on same hospital admission OR has already received >4 units of plasma.

4. History of inheritable or acquired clotting or bleeding disorder

5. Patient actively anticoagulated or has recently received (within 72h) vitamin K antagonists, direct thrombin inhibitors, heparins or Xa antagonists

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of Colorado Denver, Anshutz medical campus Aurora Colorado
United States Denver Health and Hospital Denver Colorado

Sponsors (1)

Lead Sponsor Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary TRALI (consensus definition- with exception of absence of other acute lung injury risk factors) 0-54 hours post enrollment
Secondary Change in ratio of partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) 0-54 hours post enrollment
Secondary Bleeding complications Baveno V criteria 0-5 days post-enrollmnet
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