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Prothrombin Complex Concentrate

Four Factor Prothrombin Complex Concentrate for Intracranial Hemorrhage

N/A
Waitlist Available
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes after transfusion completion
Awards & highlights

Summary

The goal of this study will be to determine whether PCC confers any benefits over FFP in traumatic and spontaneous intracranial hemorrhage with respect to multiple factors including time to correction, absolute international normalized ratio correction amount, cost, need for surgical intervention, and radiographic bleed expansion through a prospective, randomized control trial.

Eligible Conditions
  • Intracranial Hemorrhage

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes after transfusion completion
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 minutes after transfusion completion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rapid reversal of warfarin as measured by international normalized ratio (INR) drawn at 30 minutes after transfusion
Secondary outcome measures
30 day outcome as measured by the Glasgow outcome score
Absolute INR reversal as measured by INR drawn 24 hours after transfusion
Complications as measured by development of deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke, unanticipated intubation, heart failure, or need for aggressive diuresis during the hospitalization
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Four Factor Prothrombin Complex ConcentrateExperimental Treatment1 Intervention
Administration of a single dose of four factor prothrombin complex concentrate per the following dosing regimen: 25 U/kg for INR of 2-4; 35 U/kg for INR of 4-6; 50 U/kg for INR of 6+; maximum dosing weight of 100kg, patients may be dispensed +/- 10% of ordered dose
Group II: Fresh Frozen PlasmaActive Control1 Intervention
Administration of a single dose of fresh frozen plasma based on INR per the following regimen: 2U for INR of 2-2.5; 3U for INR of 2.5-3; 4U for INR of 3-3.5; 5U for INR of 3.5-4; 6U for INR of 4+

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Who is running the clinical trial?

University of UtahLead Sponsor
1,127 Previous Clinical Trials
1,793,197 Total Patients Enrolled
~0 spots leftby Sep 2025
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