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

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ClinicalTrials.gov Identifier: NCT02366845
Recruitment Status : Unknown
Verified January 2017 by University of Colorado, Denver.
Recruitment status was:  Active, not recruiting
First Posted : February 19, 2015
Last Update Posted : January 27, 2017
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Brief 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


Condition or disease Intervention/treatment Phase
Liver Disease Biological: Fresh Frozen Plasma Phase 4

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Prospective Validation of a Plasma Transfusion Dosing Algorithm in Patients With Chronic Liver Disease
Study Start Date : January 2012
Actual Primary Completion Date : January 2016
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Clinician Chosen Dosing

Admitted University of Colorado Hospital or Denver Health bleeding patients with chronic liver disease determined to receive fresh frozen plasma (FFP) for clinical indications as determined by hospital clinician. The total dose will be determined by the physician's judgment which is the current standard of care. The physician chosen dose will be utilized but physician will be unaware of which dosing strategy has been utilized.

An INR measurement will be performed within 1 hour after the entire transfusion of plasma has been administered. Primary and secondary outcome measures will be collected. No other transfused blood component, crystalloid or colloidal fluid will be infused between the first and second INR studies except plasma

Biological: Fresh Frozen Plasma
An INR dose-response curve with associated transfusion algorithm was generated for plasma in bleeding patients with chronic liver disease. In the intervention arm we will determine the plasma transfusion dose using the algorithm dosing table based on the pre-transfusion INR and the clinician chosen INR target. In the usual care group the dosing will be determined by the clinician.
Other Name: FFP

Experimental: Algorithm Dosing

Admitted University of Colorado Hospital or Denver Health bleeding patients with chronic liver disease determined to receive fresh frozen plasma (FFP) for clinical indications as determined by hospital clinician. This group will receive plasma doses based on the study dosing algorithm table.

A pre-transfusion INR and a target post-transfusion INR will be used to determine dose of FFP. The study table will reveal the dose in (ml/kg) of FFP to be transfused. An INR measurement will be performed within 1 hour after the entire transfusion of plasma has been administered. Primary and secondary outcome measures will be collected. No other transfused blood component,crystalloid or colloidal fluid will be infused between the first and second INR studies except plasma.

Biological: Fresh Frozen Plasma
An INR dose-response curve with associated transfusion algorithm was generated for plasma in bleeding patients with chronic liver disease. In the intervention arm we will determine the plasma transfusion dose using the algorithm dosing table based on the pre-transfusion INR and the clinician chosen INR target. In the usual care group the dosing will be determined by the clinician.
Other Name: FFP




Primary Outcome Measures :
  1. Accuracy of Plasma Transfusion Dosing Algorithm to accurately predict necessary plasma dose required to reach INR commonly targeted compared clinician chosen dose [ Time Frame: within 1 hour after entire plasma transfusion ]
    Ability of dosing algorithm to accurately predict necessary plasma dose (ml/kg), required to reach commonly targeted International Normalized Ratio (INR) values, compared to clinician chosen plasma transfusion dose, as determined by dose-response curve


Secondary Outcome Measures :
  1. Time (minutes) 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. [ Time Frame: minutes from first dose to initiation of procedure, anticipated timeframe between 1 minute to 8 hours. ]
  2. Dose difference (average # units) between clinician dosing and algorithm dosing (units of FFP) per patient. [ Time Frame: within 1 hour after entire plasma transfusion ]
  3. Hospital length of stay [ Time Frame: Subjects will be followed for duration of hospital stay, anticipated within 1 Day to 28 Days ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02366845


Locations
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United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Samuel C Berngard, MD University of Colorado, Denver
Principal Investigator: Marc Moss, MD University of Colorado, Denver

Publications:
Sweatt AJ, Moss M, Tripputi M, Benson AB. "A dosing formula for INR-targeted plasma transfusion in bleeding patients with chronic liver disease." American Journal of Respiratory and Critical Care Medicine 2011;183:A5828

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02366845     History of Changes
Other Study ID Numbers: 12-0064
First Posted: February 19, 2015    Key Record Dates
Last Update Posted: January 27, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases