Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2015-04-30
2016-03-31
Brief Summary
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Detailed Description
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Historically, vitamin K antagonists have been reversed using fresh frozen plasma (FFP) transfusions which, though effective, often incur delays due to the time required to obtain a type \& screen, thaw the product, and administer the product to the patient. In 2013, the FDA approved 4-factor prothrombin complex (PCC), a concentrate of factors II, VII, IX, X, protein C and protein S for use as a method for correcting vitamin K antagonist related coagulopathy. Though large, prospective randomized control trials have demonstrated efficacy and safety in a general population of all-comers bleeding, there is very little literature regarding the benefits of PCC versus FFP in the traumatic and spontaneous intracranial hemorrhage population.
Current standard of care in patients with traumatic and spontaneous intracranial hemorrhage who are on vitamin K antagonists is to reverse the effect of these agents with FFP or PCC. The choice of which agent to use is currently determined by both availability of each agent and surgeon preference. For this study, there will be an equal likelihood of either treatment being given.
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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Fresh Frozen Plasma
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+
Fresh Frozen Plasma
A pooled collection of plasma from donors
Four Factor Prothrombin Complex Concentrate
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
Four Factor Prothrombin Complex Concentrate
A purified, non-activated prothrombin complex concentrate containing factors II, VII, IX and X and proteins C \& S
Interventions
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Four Factor Prothrombin Complex Concentrate
A purified, non-activated prothrombin complex concentrate containing factors II, VII, IX and X and proteins C \& S
Fresh Frozen Plasma
A pooled collection of plasma from donors
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* INR of 2.0 or higher on arrival at the study center
* Evidence on cranial imaging of spontaneous intracranial hemorrhage, subdural hematoma, epidural hematoma, cerebral contusion, traumatic subarachnoid hemorrhage, or traumatic intraparenchymal hemorrhage
Exclusion Criteria
* Estimated survival \<24 hours
* Hypersensitivity to 4 factor prothrombin complex concentrate
* Concomitant use of novel vitamin K antagonists
* Religious/social prohibition to receiving blood products
* Need for emergent, non-neurosurgical operative intervention
* Mechanical heart valves
18 Years
ALL
No
Sponsors
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University of Utah
OTHER
Responsible Party
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Jian Guan
Neurosurgery Resident
Locations
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University of Utah Medical Center
Salt Lake City, Utah, United States
Countries
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References
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Eilertsen H, Menon CS, Law ZK, Chen C, Bath PM, Steiner T, Desborough MJ, Sandset EC, Sprigg N, Al-Shahi Salman R. Haemostatic therapies for stroke due to acute, spontaneous intracerebral haemorrhage. Cochrane Database Syst Rev. 2023 Oct 23;10(10):CD005951. doi: 10.1002/14651858.CD005951.pub5.
Other Identifiers
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IRB_00078143
Identifier Type: -
Identifier Source: org_study_id