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Hemostatic Agent
Feasibility of Evaluating XSTAT Use in the Prehospital Setting (PhoXSTAT Trial)
N/A
Waitlist Available
Led By Jan Jansen, MBBS, PhD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 29 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests the XSTAT® device, which uses expanding sponges to stop bleeding in patients with junctional wounds. The sponges quickly fill the wound and press against bleeding areas to control blood loss.
Eligible Conditions
- Bleeding
- Hemorrhagic Shock
- Penetrating Injury
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through 29 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 29 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adverse events from use of XSTAT device
Ease of use of XSTAT device by EMS personnel
Incidence of patients with hemorrhage from junctional wounds
+12 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Treatment with XSTATExperimental Treatment1 Intervention
Participants randomized to the treatment arm will be treated using the study device - XSTAT.
Group II: Standard CareExperimental Treatment1 Intervention
Participants assigned to the control group receive standard prehospital care, consisting of direct pressure/dressings.
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Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,648 Previous Clinical Trials
2,344,524 Total Patients Enrolled
Jan Jansen, MBBS, PhDPrincipal InvestigatorThe University of Alabama at Birmingham
1 Previous Clinical Trials
1,100 Total Patients Enrolled