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The purpose of this study is to demonstrate safety, effectiveness and benefit-risk profile of ResQFoam for the inhospital treatment of exsanguinating, intraabdominal haemorrhage due to trauma in patients where emergent laparotomy is required.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ResQFoam | Experimental | ResQFoam in-vivo expandable foam |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ResQFoam | Device | Hemostatic device for the treatment of emergent, exsanguinating, Class III or IV intraabdominal hemorrhagic shock in subjects due to trauma |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in systolic blood pressure after deployment of ResQFoam over baseline value | All SBP assessments prior to deployment of IP through removal of IP and completion of laparotomy. Patient will be followed through hospital discharge or through Day 30, whichever comes first. |
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Inclusion Criteria:
Estimated age of 15 years or older (or subject weight estimated at greater than 50 kg if age is unknown)
Emergent, exsanguinating hemorrhage, from abdominal source as defined by:
Confirmation of abdominal hemorrhage by:
No other known, uncontrolled active sources of hemorrhage
Subject is intubated and sedated per local guidelines
Decision to administer foam is made within 30 minutes of admission to the emergency department.
Decision made to proceed to emergent laparotomy made within 30 minutes of admission to the emergency department.
Definitive surgical care is expected to occur within three hours of foam deployment
Subject must also be receiving concurrent transfusion of fluids or blood products.
Exclusion Criteria:
Known or suspected major diaphragm injury
Known or suspected untreated pneumothorax
Known or suspected untreated hemothorax
Known or suspected blunt or penetrating cardiac or thoracic aortic trauma
Traumatic brain injury resulting in decapitation, visible brain matter or considered non- survivable based on initial physical exam
Received greater than five consecutive minutes of cardiopulmonary resuscitation in the pre-emergency department setting
Patients with Pulseless Electrical Activity
Known allergy to isocyanate
Known or suspected pregnancy
History of prior abdominal surgery or evidence of abdominal surgery (scars)
Disrupted abdominal wall that, in the opinion of the investigator would preclude ResQFoam from being adequately contained within the abdominal cavity
Subject in whom the abdominal aortic junctional tourniquet (AAJT) or Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) techniques have been used
Known Prisoners
Subjects with burns > 20% of total body surface area
Subject/legally authorized representative/subject family member purposefully opted out of participation in the study
Known Do Not Resuscitate order (DNR) or Physician Orders for Life Sustaining Treatment (POLST)
Known enrollment in another randomized, interventional study
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carol Pekar, RAC | Contact | 508-523-5456 | cpekar@arsenalmedical.com |
| Name | Affiliation | Role |
|---|---|---|
| Timothy Pritts, MD | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Recruiting | Birmingham | Alabama | 35294 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38441108 | Derived | Maegele M. Effective approaches to address noncompressible torso hemorrhage. Curr Opin Crit Care. 2024 Jun 1;30(3):202-208. doi: 10.1097/MCC.0000000000001141. Epub 2024 Feb 28. |
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| ID | Term |
|---|---|
| D012771 | Shock, Hemorrhagic |
| D014947 | Wounds and Injuries |
| D058734 | Exsanguination |
| D012774 | Shock, Traumatic |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
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| University of Cincinnati | Recruiting | Cincinnati | Ohio | 45219 | United States |
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