Clinical trial NCT04663087: Feasibility of Evaluating XSTAT Use in the Prehospital Setting
Official title: A Pilot Randomized Clinical Trial of the XSTAT Hemostatic Device in the Prehospital Setting
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Shock, Hemorrhagic
Injury Penetrating
Hemorrhage
Keywords: hemorrhagic shock
hemostatic sponge
penetrating injury
junctional wounds
prehospital
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2020-12-10
Enrollment: 1
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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 rather than from external compression (as with a tourniquet or manual compression).

Hemorrhage should be controlled as early as possible, ideally before reaching a trauma center or medical treatment facility. Given its small size, low weight, and ease of application, the XSTAT® device is well-suited for prehospital use, in both the civilian and military setting, and this is probably where the device's applicability lies.

The investigators anticipate that a full-scale trial will be conducted based on the questions this pilot study addresses, including the following:

1. the number of penetrating junctional zone injuries encountered in the prehospital civilian setting.
2. the feasibility of randomizing patients in the prehospital setting.
3. usability.
4. safety.
5. validation of the proposed primary outcome of an efficacy trial.

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.

Primary outcomes:
measure: Incidence of Patients With Hemorrhage From Junctional Wounds
timeFrame: Each participant was assessed at the time of arrival in hospital
measure: Record Blood Lactate Level Result
timeFrame: Baseline - on admission
measure: Base Deficit (mmol/l)
timeFrame: Baseline - on admission
measure: Record Hemoglobin/Hematocrit Result
timeFrame: Baseline - on admission
measure: Record Platelet Count Result
timeFrame: Baseline - on admission
measure: Record Prothrombin Time Result
timeFrame: Baseline - on admission
measure: Record International Normalized Ratio (INR) Result
timeFrame: Baseline - on admission
measure: Record Activated Partial Thromboplastin Time (APTT) / Ratio Result
timeFrame: Baseline - on admission
measure: Record Thromboelastograph (TEG) Result if Available
timeFrame: Baseline - on admission
measure: Record Thromboelastogram (ROTEM) Result if Available
timeFrame: Baseline - on admission
measure: Ease of Use of XSTAT Device by EMS Personnel
timeFrame: From baseline to 29 months (enrollment phase)
measure: 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.
timeFrame: From baseline to 29 months (enrollment phase)
measure: Adverse Events From Use of XSTAT Device
timeFrame: Randomization through first 7 days, unless discharged earlier
measure: Survival at 30 Days
timeFrame: Hospital admission through 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Hospital
state: Alabama
Study officials:
affiliation: The University of Alabama at Birmingham
name: Jan Jansen, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.