FFP Versus PCC in Intracranial Hemorrhage

NCT02429453 | Withdrawn DMC

• 1 other identifier: IRB_00078143
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhage, Spontaneous

Keywords

Warfarin; Traumatic intracranial hemorrhage; prothrombin complex concentrate; fresh frozen plasma; Spontaneous intracranial hemorrhage

Outcome Measures

Primary Outcomes (1)

• Rapid reversal of warfarin as measured by international normalized ratio (INR) drawn at 30 minutes after transfusion

  INR level 30 minutes after transfusion completion of FFP or 4 factor prothrombin complex concentrate

  30 minutes after transfusion completion

Secondary Outcomes (11)

• Radiographic expansion of traumatic intracerebral hemorrhage as measured by CT scan within 24 hours of presentation

  24 hours after presentation

• Timing of reversal of warfarin as measured by INR drawn at 3 hours, 8 hours and 24 hours after transfusion

  3-24 hours after completion of FFP or 4 factor prothrombin complex concentrate transfusion

• Thromboelastography response as measured by results of ROTEM analysis at 30 minutes and 24 hours after transfusion

  30 minutes and 24 hours after completion of FFP or 4 factor prothrombin complex concentrate transfusion

• Absolute INR reversal as measured by INR drawn 24 hours after transfusion

  24 hours after completion of FFP or 4 factor prothrombin complex concentrate transfusion

• Need for operative intervention as measured by need for neurosurgical procedure during the hospitalization

  During duration of hospital stay, an expected average of 1 week

Study Arms (2)

Fresh Frozen Plasma

ACTIVE COMPARATOR

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+

Biological: Fresh Frozen Plasma

Four Factor Prothrombin Complex Concentrate

EXPERIMENTAL

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

Drug: Four Factor Prothrombin Complex Concentrate

Interventions

Four Factor Prothrombin Complex Concentrate DRUG

A purified, non-activated prothrombin complex concentrate containing factors II, VII, IX and X and proteins C \& S

Also known as: Kcentra

Four Factor Prothrombin Complex Concentrate

Fresh Frozen Plasma BIOLOGICAL

A pooled collection of plasma from donors

Fresh Frozen Plasma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Coumadin use
• 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

You may not qualify if:

• Unable to obtain consent
• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Medical Center

Salt Lake City, Utah, 84132, United States

Location

Related Publications (1)

• 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.

  PMID: 37870112 DERIVED

MeSH Terms

Conditions

Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Hemophilia B

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, X-Linked

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurosurgery Resident

Study Record Dates

• First Submitted: April 21, 2015
• First Posted: April 29, 2015
• Study Start: April 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: November 16, 2016

Record last verified: 2016-11

Locations

US (1)