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Cohort A - Historical Cohort for Bleeding (REVERXaL Trial)

N/A
Recruiting
Research Sponsored by AstraZeneca
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 cohort a: from admission for the bleeding (index date) until hospital discharge. cohort b: from index date (time of administration of reversal/replacement agent) to hospital discharge (up to 90 days)
Awards & highlights

REVERXaL Trial Summary

REVERXaL study aims to increase the understanding of the patient characteristics, bleeding presentation, health care interventions provided, and the clinical as well as self-reported health outcomes of patients with major bleeding in the presence of Factor Xa inhibitor treatment. The generation of insight on treatment approaches and associated outcomes in hospitalized patients with Factor Xa inhibitor-related major bleeds may inform clinical guidelines, health system decision making and streamline treatment pathways in this population.

Eligible Conditions
  • Bleeding

REVERXaL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cohort a: from admission for the bleeding (index date) until hospital discharge. cohort b: from index date (time of administration of reversal/replacement agent) to hospital discharge (up to 90 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and cohort a: from admission for the bleeding (index date) until hospital discharge. cohort b: from index date (time of administration of reversal/replacement agent) to hospital discharge (up to 90 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical presentation
Demographics (age in years)
Demographics (ethnicity)
+6 more
Secondary outcome measures
5-Dimension Health Questionnaire 5 Level (EQ-5D-5L) - Cohort B
Clinical outcomes - Cohort B
Short Form Health Survey (SF-36) - Cohort B
+1 more

REVERXaL Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort B - Prospective CohortExperimental Treatment1 Intervention
Cohort B will enrol approximately 2000 patients who were administered any reversal or replacement agent during the acute care phase for a major bleeding in the presence of Factor Xa inhibitor treatment at the participating sites. Patients will be followed up to three months after administration of reversal or replacement therapy.
Group II: Cohort A - Historical CohortExperimental Treatment1 Intervention
Cohort A will comprise of approximately 2000 patients admitted for major bleedings in the presence of Factor Xa inhibitor treatment during a defined period (up to 2 years prior to commencing enrolment of patients in Cohort B). Patients who developed major bleeding in the presence of Factor Xa inhibitor treatment while already admitted in hospitals will also be included. Patients may or may not have received a reversal/replacement therapy. Patients are followed in medical charts from admission to discharge.

Find a Location

Who is running the clinical trial?

ParexelIndustry Sponsor
303 Previous Clinical Trials
96,826 Total Patients Enrolled
AstraZenecaLead Sponsor
4,259 Previous Clinical Trials
288,589,902 Total Patients Enrolled
1 Trials studying Bleeding
13,000 Patients Enrolled for Bleeding

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study to Describe the Characteristics, Health Care Interventions and Outcomes of Patients With Major Bleedings in the Presence of Factor Xa Inhibitor Treatment
2023. "A Study to Describe the Characteristics, Health Care Interventions and Outcomes of Patients With Major Bleedings in the Presence of Factor Xa Inhibitor Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06147830.
All > Kansas City
~2667 spots leftby Mar 2025
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