Predicting Lung Injury From Transfusion in Patients With Liver Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2016-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Transfusion-related Acute Lung Injury Chronic Liver Disease Gastrointestinal Bleeding

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion 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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No