PhoXstat

A PILOT RANDOMIZED CLINICAL TRIAL OF THE XSTAT® HEMOSTATIC DEVICE IN THE PREHOSPITAL SETTING

Uncontrolled bleeding is the leading cause of preventable death following injury. Of those deaths, almost half occur before the patient reaches an emergency care facility. While tourniquets can be applied to wounds on certain parts of the body like arms and legs, some areas of the body, like the shoulders, armpits, hips, and pelvis, are difficult to apply direct or indirect pressure to. For these type of wounds, emergency medical personnel have very few options to controlling bleeding. More research must be done to guide treatment for this common, disabling and potentially lethal health problem.
 

This study uses a novel product called XSTAT. It has been used in the military setting to control bleeding in wounds on the battlefield. The purpose of this study is to see whether XSTAT can be formally studied in a civilian EMS system. If this small study shows that XSTAT might be helpful in this setting, we will conduct a larger study to evaluate whether XSTAT makes a difference to patients’ outcomes


Do you have any comments you would like to tell the researchers about this study?  We would value your feedback via the link below.  Your feedback will remain confidential.

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FAQs

  • The XSTAT device is a syringe-like device that contains approximately 40 non-absorbable, small, highly-compressed sponges. The sponges expand when they make contact with blood or fluid, creating a pressure dressing from inside the wound. These novel devices were approved by the FDA in 2014 for temporarily controlling bleeding from these difficult wounds. The sponges are safe to leave in place for up to 4 hours, until the patient can be taken to surgery to stop the bleeding.

  • Patients who have suffered a penetrating injury (typically a gunshot wound or stab wound) to the groin or axilla (armpit), have visible bleeding and are thought to be at least 18 years old will be included.

    The formal eligibility criteria (which describe the patient characteristics that are required to be included in the study, as well as characteristics that would exclude the patient from the study) are as follows.

    Inclusion Criteria

    Subjects must meet all of the following:

    • Age ≥ 18 years or estimated body weight ≥ 50 kg.
    • Penetrating junctional injury (femoral or axillary), with
      • visible bleeding,
      • too proximal to be controlled with a tourniquet.
    • Patient is taken to participating Level 1 trauma center, directly from the scene.

    Exclusion Criteria

    This study will exclude the following subjects:

    • Prisoners.
    • Children younger than 18 years old.
    • Patients who are known to be pregnant.
    • Patients receiving chest compressions (prior to XSTAT® use).
    • Patients with an opt-out bracelet.

  • Participating Emergency Medical Services (EMS) agencies will carry a pre-packaged, sealed, numbered trial plastic case, which either contains either two XSTAT® devices, or is empty. When a suitable patient meeting the inclusion criteria for the trial is identified by the EMS providers, the pack is opened. If it contains the device, it will be used as indicated and approved by the FDA. If it does not contain the device, the paramedics will provide the normal standard of care. No care will be withheld because of the research trial.

  • The study will be conducted in three locations across the United States, including middle Tennessee. EMS personnel for Nashville Fire will be trained and participate in this study. Additionally, medical helicopters from Vanderbilt LifeFlight in middle Tennessee will also carry the devices.

  • A total of 52 patients will be enrolled across all participating sites in the United States. In Tennessee we anticipate almost 20 people will be enrolled in this study.

  • The first patient is expected to be enrolled in the summer of 2020. The start time will be different at each site depending on when they receive approval to begin the study.

  • The study enrollment is expected to last approximately two years once all sites have begun enrolling.

  • Patients in this study will have suffered a serious and potentially life-threatening injury, causing significant blood loss, and requiring immediate lie-saving interventions. These types of injuries occur unexpectedly, and it is not possible for people to sign up to take part ahead of time. Most patients will be unconscious (unable to speak or hear) and too sick to consent to immediate treatment, or participation in the study. The EMS personnel will therefore enroll patients into the study without their consent.

  • Research is normally only conducted with the express permission of the patient. However, it is often not possible to obtain patients’ consent to study treatments that are administered in life-threatening emergencies – but such research still has to be done. The PhoXSTAT trial will be therefore conducted under federal regulations that allow an exception from informed consent (EFIC).

  • In 1996, the Food and Drug Administration (FDA) developed specific regulations to permit emergency research without prospective consent under carefully controlled circumstances. This is in recognition of the unique kind of emergency medical situations in which patients or family members cannot give informed consent before treatment as well as the need to allow emergency care to advance through research.

    Learn more about EFIC here.

  • There isn’t time. In order to give permission to participate in a study, it is important that the person giving permission understands what is being said to them, and can make a well-informed decision. Family members are usually very upset during a medical emergency and are not able to concentrate or comprehend what is being said during the emergency. A serious injury is an extreme emergency during which the patient could potentially die if treatment is not begun immediately. Patients suffering significant blood loss may be unconscious or too sick to discuss their treatment, and any time taken to discuss their treatment with family deprives the patient of immediately starting life-saving measures.

  • The study treatment will have been completed when the patient arrives in the emergency department. If it is feasible, an attempt will be made to obtain informed consent from the patient’s legally authorized representative or directly from the patient, if possible. The study continues until the bleeding is under control. If informed consent is not obtained before the end of the enrollment period, no further efforts will be made. However, notification of the patient’s enrollment in the study will be attempted. The patient, the patient’s legally authorized representative or family member will be given the opportunity to withdraw the patient from further study participation and will be provided instruction for how to do so.

  • As is possible with any treatment, there are risks involved. Patient safety is carefully monitored and recorded for any complications of study treatments. The patients in this study will be treated with either an Xstat device or the standard of care for these injuries. The risk of some sponges being left in the wound after surgery is small. Each sponge has a small radiopaque indicator, so the sponges show up on x-ray. Because the Xstat device is already approved by the FDA, there is no incremental increase in risks as a result of this clinical trial.

  • Yes. We will provide an “Opt Out” wristband for those people who do not want to be enrolled in the study.

    Learn more about how to opt out here.