Predicting Lung Injury From Transfusion in Patients With Liver Disease
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Purpose
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.
| Condition |
|---|
|
Transfusion-related Acute Lung Injury Chronic Liver Disease Gastrointestinal Bleeding |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Endogenous Heparinoid Interference With Coagulation on Thromboelastogram as a Predictive Biomarker for TRALI |
- TRALI (consensus definition- with exception of absence of other ALI risk factors) [ Time Frame: Within 54 hours of enrollment ] [ Designated as safety issue: No ]
- Change in PaO2/FiO2 ratio [ Time Frame: within 54 hours of enrollment ] [ Designated as safety issue: No ]
- Bleeding complications [ Time Frame: 0-5 days post-enrollmnet ] [ Designated as safety issue: No ]Baveno V criteria
| Estimated Enrollment: | 120 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
Contacts and Locations| United States, Colorado | |
| University of Colorado Denver, Anshutz medical campus | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Alex b Benson, MD 303-724-6063 alexander.benson@ucdenver.edu | |
| Principal Investigator: Alexander B Benson, MD | |
| Denver Health and Hospital | Recruiting |
| Denver, Colorado, United States, 80207 | |
| Contact: Alexander B Benson, MD 303-724-6063 alexander.benson@ucdenver.edu | |
| Principal Investigator: Alexander B Benson, MD | |
More Information
No publications provided
| Responsible Party: | Alexander Benson, Assistant Professor, University of Colorado, Denver |
| ClinicalTrials.gov Identifier: | NCT01756690 History of Changes |
| Other Study ID Numbers: | 09-0238 |
| Study First Received: | December 20, 2012 |
| Last Updated: | March 15, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Colorado, Denver:
|
respiratory distress syndrome, adult blood component transfusion gastrointestinal hemorrhage blood coagulation |
Additional relevant MeSH terms:
|
Gastrointestinal Hemorrhage Hemorrhage Liver Diseases Acute Lung Injury Respiratory Distress Syndrome, Adult Lung Injury Gastrointestinal Diseases |
Digestive System Diseases Pathologic Processes Lung Diseases Respiratory Tract Diseases Respiration Disorders Thoracic Injuries Wounds and Injuries |
ClinicalTrials.gov processed this record on May 22, 2013