ClinConnect ClinConnect Logo
Search / Trial NCT04663087

Feasibility of Evaluating XSTAT Use in the Prehospital Setting

Launched by UNIVERSITY OF ALABAMA AT BIRMINGHAM · Dec 4, 2020

Trial Information

Current as of April 29, 2025

Terminated

Keywords

Hemorrhagic Shock Hemostatic Sponge Penetrating Injury Junctional Wounds Prehospital

ClinConnect Summary

The XSTAT® device injects small, rapidly-expanding cellulose sponges into the wound cavity using a syringe-like delivery system. In the wound, XSTAT® sponges expand and swell to fill the wound cavity, within 20 seconds of contact with blood, facilitating compression of bleeding structures. XSTAT® can be applied through skin wounds. The system can readily access deep vascular structures. While rapidly hemostatic, the hemostatic sponges are also relatively easy to remove. In the setting of junctional bleeding, XSTAT® may allow for hemostatic pressure generation from within the wound tract rat...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Age ≥15 years or estimated body weight ≥50 kg.
  • 2. Penetrating junctional injury (femoral or axillary), with i. visible bleeding ii. too proximal to be controlled with a tourniquet
  • 3. Patient will be taken to participating level I trauma center, directly from the scene
  • Exclusion Criteria:
  • 1. Prisoners, children \<15 years old, known pregnant patients.
  • 2. Patients receiving chest compressions (prior to XSTAT® use).
  • 3. Patients with an opt-out bracelet.

About University Of Alabama At Birmingham

The University of Alabama at Birmingham (UAB) is a prominent academic institution and research hub dedicated to advancing healthcare through innovative clinical trials. Renowned for its commitment to medical discovery and education, UAB conducts cutting-edge research across a wide array of disciplines, including oncology, cardiology, neurology, and public health. With a robust infrastructure for clinical research, UAB fosters collaboration among interdisciplinary teams, leveraging state-of-the-art facilities and resources to enhance the translation of scientific findings into effective treatments and interventions. As a leader in clinical research, UAB aims to improve patient outcomes and contribute to the broader medical community through rigorous trial design and implementation.

Locations

Birmingham, Alabama, United States

Patients applied

0 patients applied

Trial Officials

Jan Jansen, MBBS, PhD

Principal Investigator

The University of Alabama at Birmingham

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Similar Trials