RECRUITING

Evaluation of 4-Factor PCC in DOAC-associated Intracranial Hemorrhage

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Intracranial hemorrhage (ICH) can occur due to traumatic and spontaneous events.1 The incidence of non-traumatic, spontaneous ICH is approximately 40,000 to 67,000 cases per year while the incidence of traumatic brain injury (TBI) is nearly 1.7 million annually

Official Title

Evaluation of 4-Factor PCC in DOAC-associated Intracranial Hemorrhage

Quick Facts

Study Start:2023-07-13
Study Completion:2024-07-13
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06096051

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * • ≥18 years of age
  2. * ICH (traumatic and spontaneous)
  3. * Administration of at least one dose of 4F-PCC
  4. * Admitted to the MHS between July 1, 2018 and May 30, 2023
  5. * Rivaroxaban or apixaban use prior to admission
  1. * • Warfarin or dabigatran use prior to admission
  2. * Prisoners
  3. * Pregnancy
  4. * \<18 years of age

Contacts and Locations

Study Contact

Bethany Brauer, MPH
CONTACT
214-947-1281
MHSIRB@mhd.com
Colette Ngo Ndjom, MS
CONTACT
214-947-4681
mhsirb@mhd.com

Principal Investigator

Tamara Reiter, PharmD
PRINCIPAL_INVESTIGATOR
Methodist Midlothian Medical Center

Study Locations (Sites)

Methodist Dallas Medical Center
Dallas, Texas, 75203
United States

Collaborators and Investigators

Sponsor: Methodist Health System

  • Tamara Reiter, PharmD, PRINCIPAL_INVESTIGATOR, Methodist Midlothian Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-13
Study Completion Date2024-07-13

Study Record Updates

Study Start Date2023-07-13
Study Completion Date2024-07-13

Terms related to this study

Additional Relevant MeSH Terms

  • Intracranial Hemorrhage