Treatment with XSTAT for Bleeding

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Bleeding+2 MoreXSTAT - Device
Eligibility
Any Age
All Sexes
What conditions do you have?
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Study Summary

This study evaluates the prehospital use of the XSTAT device to control bleeding in junctional wounds. Participants will be randomized to the use of XSTAT versus standard care.

Eligible Conditions
  • Bleeding
  • Penetrating Injury
  • Hemorrhagic Shock

Treatment Effectiveness

Study Objectives

15 Primary · 0 Secondary · Reporting Duration: Through 29 months

Baseline - on admission
Record activated partial thromboplastin time (APTT) / ratio result
Record activated partial thromboplastin time (APTT) result
Record base deficit result
Record blood lactate level result
Record hemoglobin/hematocrit result
Record international normalized ratio (INR) result
Record platelet count result
Record prothrombin time result
Record thromboelastogram (ROTEM) result if available
Record thromboelastograph (TEG) result if available
Month 29
Ease of use of XSTAT device by EMS personnel
Sponge removal: surgeon opinion of ease of removal, time required to remove sponges, use of x-rays, whether surgeon was satisfied or dissatisfied with the XSTAT device.
Day 30
Survival at 30 days
Day 7
Adverse events from use of XSTAT device
Through 29 months
Incidence of patients with hemorrhage from junctional wounds

Trial Safety

Trial Design

1 Treatment Group

Treatment with XSTAT
1 of 1

Experimental Treatment

50 Total Participants · 1 Treatment Group

Primary Treatment: Treatment with XSTAT · No Placebo Group · N/A

Treatment with XSTAT
Device
Experimental Group · 1 Intervention: XSTAT · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through 29 months

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,432 Previous Clinical Trials
2,219,020 Total Patients Enrolled
Jan Jansen, MBBS, PhDPrincipal InvestigatorThe University of Alabama at Birmingham
1 Previous Clinical Trials
1,100 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 3 Total Inclusion Criteria

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