Expired Study
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Aurora, Colorado 80045


Purpose:

This study plans to learn more about transfusion of a human blood component called plasma in patients who have liver problems. Patients are asked to be in this study because they have liver disease and therefore may require the transfusion of plasma. The dose of plasma required to reach certain blood clotting laboratory targets is usually determined by clinicians. Due to the complexity of the patient's blood clotting disorder, determining the appropriate dose of plasma is very difficult. The investigators have developed a dosing table based on information from other patients with liver disease and the investigators are testing it to see if it is a more accurate dosing tool then clinician chosen dosing of plasma in patients with liver disease who need one or more plasma transfusions


Study summary:

Clinicians currently transfuse plasma to International Normalized Ratio (INR) targets without an understanding of the dose response characteristics of plasma in bleeding patients with liver disease. Epidemiologic studies show that INR is infrequently corrected to target INR values after clinician chosen plasma transfusion doses in patients with liver disease. Plasma transfusion is frequently given to patients prior to procedures and during active bleeding in this patient population though there are no dosing guidelines to aid clinicians in reaching INR targets in patients with liver disease. Previous studies suggest that patients with liver disease may need more plasma then patients without liver disease to correct any given pre-transfusion INR to the same post-INR target. Current physician dosing of plasma is variable and rarely successful at reaching stated INR targets. The INR thresholds commonly used triggers for plasma transfusion by Gastro-Intestinal (GI), Hepatology and critical care physicians at our institution range from 1.5-3.0 in bleeding or pre-procedural patients with liver disease representing tremendous variability. When we evaluated plasma transfusion dosing practices in bleeding patients with liver disease over 8 years, we demonstrated that these same physicians rarely met stated theoretical targets. Over or under dosing plasma in these patient may lead to serious clinical complications.


Criteria:

Inclusion Criteria: Subjects will be eligible to participate in the study if they meet all of the following criteria: 1. Admission to the University of Colorado Hospital or Denver Health hospital and the clinical care team plans to transfuse the patient plasma to target a specific INR value. (reason for transfusion is not considered). 2. Patient has chronic liver disease defined as 1 or more of the following: Previous diagnosis of chronic liver disease OR -Imaging or biopsy diagnosis of cirrhosis; or 3. Signs of portal hypertension (ascites, varices, hypersplenism), or 4. Laboratory evidence of synthetic dysfunction (INR>1.5, bilirubin> 2.0 mg/dL, albumin<2.5 mg/dL) 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 2. Patient actively taking vitamin K antagonists 3. Inability to obtain consent 4. Clinical team does not desire to target a specific INR value 5. Pregnant patients and prisoners 6. Patients with Acute Liver Failure


NCT ID:

NCT02366845


Primary Contact:

Principal Investigator
Samuel C Berngard, MD
University of Colorado, Denver


Backup Contact:

N/A


Location Contact:

Aurora, Colorado 80045
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 17, 2017

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