Phase 4
N=50
Prospective Validation of a Plasma Transfusion Dosing Algorithm in Patients With Chronic Liver Disease
Liver Disease
Bottom Line
View on ClinicalTrials.gov: NCT02366845 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Number of Participants That Reached Targeted International Normalized Ratio (INR) Within ±0.1 After First Fresh Frozen Plasma (FFP) Transfusion Completed. — 7; 17 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Fresh Frozen Plasma (Biological); Pre-Transfusion International Normalized Ratio (INR) (Diagnostic_test); Post-Transfusion International Normalized Ratio (INR) (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants That Reached Targeted International Normalized Ratio (INR) Within ±0.1 After First Fresh Frozen Plasma (FFP) Transfusion Completed. |
7; 17 | — |
| SECONDARY Time (Hours) From Initiation of First Dose of Plasma to Initiation of Planned Procedure (in Patient Undergoing Transfusion Before a Procedure) for Clinician Dosing Compared to Algorithm Dosing Strategies. |
4.9; 3.5 | — |
| SECONDARY Dose Difference (Average # Units) Between Clinician Dosing and Algorithm Dosing (Units of FFP) Per Patient. |
2.4; 3.1 | — |
| SECONDARY Hospital Length of Stay |
13.8; 11.0 | — |
Summary
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
Eligibility Criteria
Inclusion Criteria
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
Data sourced from ClinicalTrials.gov (NCT02366845). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.