NCT04663087: PhoXSTAT

Feasibility of Evaluating XSTAT Use in the Prehospital Setting

Terminated NA Results posted Last updated 30 December 2024

What this trial tests

NA trial testing XSTAT in Shock, Hemorrhagic in 1 participant. Terminated before completion.

Timeline

29 October 2022

Primary endpoint
21 June 2023

11 August 2023

Quick facts

Lead sponsor	University of Alabama at Birmingham
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1
Start date	29 October 2022
Primary completion	21 June 2023
Estimated completion	11 August 2023
Sites	1 location across United States

Drugs / interventions tested

• XSTAT
• Standard of Care

Conditions studied

• Shock, Hemorrhagic — all drugs for Shock, Hemorrhagic →
• Injury Penetrating — all drugs for Injury Penetrating →
• Hemorrhage — all drugs for Hemorrhage →

Sponsor

University of Alabama at Birmingham

Who can join

15 and older, any sex, with Shock, Hemorrhagic or Injury Penetrating. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Incidence of Patients With Hemorrhage From Junctional Wounds Primary · Each participant was assessed at the time of arrival in hospital

The investigators will track the number of junctional wounds that are treated by participating EMS personnel versus the number of participants who were enrolled in this study. This will help the investigators understand how many wounds of this type happen, and how many would possibly benefit from the use of the XSTAT device.

Group	Value	95% CI
Treatment With XSTAT	0
Standard Care	1

Record Blood Lactate Level Result Primary · Baseline - on admission

Record results of routine test

Group	Value	95% CI
Standard Care	3.5

Base Deficit (mmol/l) Primary · Baseline - on admission

Base excess and base deficit refer to an excess or deficit, respectively, in the amount of base present in the blood. The value is usually reported as a concentration in units of mEq/L (mmol/L), with positive numbers indicating an excess of base and negative a deficit. A typical reference range for base excess is -2 to +2 mEq/L. It is a test performed on a blood sample, venous or arterial. In trauma patients, a metabolic acidosis is indicative of the degree of shock, causing hypoperfusion. A more negative value indicates more severe acidosis, and more severe shock.

Group	Value	95% CI
Standard Care	-2.1

Record Hemoglobin/Hematocrit Result Primary · Baseline - on admission

Record results of routine test

Group	Value	95% CI
Standard Care	12.7

Record Platelet Count Result Primary · Baseline - on admission

Record results of routine test

Group	Value	95% CI
Standard Care	267

Record Prothrombin Time Result Primary · Baseline - on admission

Record results of routine test

Group	Value	95% CI
Standard Care	13.8

Record International Normalized Ratio (INR) Result Primary · Baseline - on admission

Record results of routine test

Group	Value	95% CI
Standard Care	1.1

Record Activated Partial Thromboplastin Time (APTT) / Ratio Result Primary · Baseline - on admission

Record results of routine test

Group	Value	95% CI
Standard Care	27

Survival at 30 Days Primary · Hospital admission through 30 days

Time of death, or survival at 30 days will be recorded

Group	Value	95% CI
Standard Care	1

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.