Prospective Validation of a Plasma Transfusion Dosing Algorithm in Patients With Chronic Liver Disease

Completed · Phase 4

Conditions studied: Liver Disease

In brief

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

Key facts

Study ID

NCT02366845

Run by

University of Colorado, Denver

People needed

50

Starts

2012-06-27

Expected to finish

2019-03-27

Last updated by the study team

2019-10-29

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects will be eligible to participate in the study if they meet all of the following criteria:
• 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).
• 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
• Signs of portal hypertension (ascites, varices, hypersplenism), or
• 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
• Patient under age 18
• Patient actively taking vitamin K antagonists
• Inability to obtain consent
• Clinical team does not desire to target a specific INR value
• Pregnant patients and prisoners
• Patients with Acute Liver Failure

Where it is running

• University of Colorado Hospital — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.