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
Effectiveness Progress
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
Safety Progress
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: DeviceTrial 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
Mark “Yes” if the following statements are true for you:References
- Stephens SW, Farley P, Collins SP, Wong MD, Panas AB, Dennis BM, Richmond N, Inaba K, Brown KN, Holcomb JB, Jansen JO. Multicenter social media community consultation for an exception from informed consent trial of the XStat device (PhoXStat trial). J Trauma Acute Care Surg. 2022 Feb 1;92(2):442-446. doi: 10.1097/TA.0000000000003425.
- Jan O. Jansen 2022. "Feasibility of Evaluating XSTAT Use in the Prehospital Setting". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04663087.
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Conditions
Cancer Related
Treatments