Introducing the Trial
To demonstrate safety, effectiveness and benefit-risk profile of ResQFoam for the in-hospital treatment of emergent, exsanguinating, intraabdominal hemorrhage resulting in Class III or IV hemorrhagic shock due to trauma.
This is a single arm, multi-center clinical trial designed to demonstrate the clinical benefit and efficacy of ResQFoam through the measurement of an improved systolic blood pressure over baseline following intervention. Additionally, this study will evaluate the safety of ResQFoam through the assessment of all adverse events with discrimination of those directly attributed to the use of the device. This study will take place in Level I Trauma centers.
Emergency Research for Abdominal Bleeding
Patients with severe internal abdominal bleeding suffer from a high rate of death. A recent study by Harvin et al found that over 40% of patients who lived long enough to receive emergency surgery still died at leading trauma centers. The authors concluded that the mortality rate resulting from bleeding and shock has not changed since the early 1990s, even in modern hospitals with abundant resources.
There has been very little innovation in treatment of these patients. Pre-surgical fluids and traveling to the operating room more rapidly have not resulted in improved survival. There is a strong need to new treatments to reduce death related to trauma. New treatments must be studied carefully in a controlled environment, by our most capable surgeons. A controlled trial is the only way to truly determine if new treatments help patients. Based on studies in animals ResQFoam has significant potential benefit. This clinical study will determine if the device is safe and effective in trauma patients.
Arsenal Medical has developed ResQFoam, a new device for control of severe, life-threatening intraabdominal hemorrhage. ResQFoam consists of a delivery device and two liquid phase components that are mixed to form a foam in the abdomen. The foam surrounds abdominal organs and applies local pressure to the site of injury. By controlling the bleeding, the injured patient can be stabilized and transported to surgery. During surgery, the solidified foam is removed and bleeding is stopped surgically. An animation of the foam is shown here:
The ResQFoam dose has been optimized such that one ResQFoam kit will be used per subject; ResQFoam is used only in adults.
Exception from Informed Consent (EFIC)
Since the vast majority of patients requiring an emergent intervention following trauma are unable to provide informed consent, the Food and Drug Administration allows for the use of Exception from Informed Consent (EFIC). In order to qualify for an EFIC:
- The study must involve participants suffering from a life-threatening injury
- Available treatments must be unproven or unsatisfactory
- Collection of scientific evidence is necessary to determine the safety and effectiveness of the intervention
- Obtaining informed consent must not be feasible as a result of their medical condition
- The intervention must be administered before consent can be obtained
- There is no reasonable way to identify prospectively individuals likely to become eligible for participation
- Participation in the research holds out the prospect of benefit to the subjects
- The study could not be carried out without the waiver.
Additional information regarding EFIC can be obtained here.
Research being performed with an EFIC waiver is highly regulated. The proposal is first critically appraised by another, uninvolved physician with expertise the field of study. The proposal is also reviewed by the institutional review board (IRB) at a participating site.
The Principal Investigator must then lead a process called “community consultation.” During community consultation, the study is advertised in the region in which it will take place with a request for feedback and comments. The Principal Investigator also meets with community organizations to describe the proposed study and seek in-person feedback.
Frequently Asked Questions
1. Who will be included in this study?
All patients presenting to a participating site with life-threatening trauma requiring immediate surgery will be screened for eligibility for the study. Patients meeting all inclusion criteria, without any exclusion criteria, will be enrolled in the study.
- Estimated age of 15 years or older (or subject weight greater than 50 kg if age is unknown)
- Emergent, exsanguinating hemorrhage, from abdominal source as defined by:
- Class III or IV hemorrhagic shock or
- Assessment of blood consumption (ABC) score ≥ 2
- Confirmation of abdominal hemorrhage by:
- Direct visualization or
- Positive Focused Assessment with Sonography in Trauma (FAST) or
- Diagnostic Peritoneal Aspiration (DPA)
- 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
- 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
2. How many patients will be enrolled?
Up to 40 patients will be included in the study.
3. When will the study start?
The study will begin in 2018
4. Once the patient reaches the emergency department, why can’t family be contacted to provide consent?
The patient population in this study will be severely injured and suffering from severe and uncontrolled bleeding in the abdomen. Per ATLS guidelines, patients experiencing this type of bleeding are characterized by greater than 30% blood loss, reduced blood pressure, and will have an anxious, confused, or lethargic mental status. Therefore, patients will be incapable of providing legally effective informed consent as required by 21CFR50.20.
To be effective, ResQFoam must be administered rapidly in the initial period (within 30 minutes) of patient arrival to the emergency department (ED). Due to the circumstances necessitating the medical condition, Legally Authorized Representatives (LAR), such as a spouse or family member, are often not immediately available when the patient arrives to the ED. Because of likely unavailability of the LAR and the emergent need to treat hemorrhage due to the mortality associated with it, there may be insufficient time to obtain consent from a LAR prior to treatment with ResQFoam within this window. Because this trial involves traumatic injury which is unpredictable and may originate from many causes, there is no way to prospectively identify individuals who are likely to become eligible for this trial. The investigator will, at the earliest feasible opportunity, inform the subject, the subject’s LAR, and/or family member (1) of the subject’s inclusion in the study, the details of the investigation and other information contained in the informed consent document, and (2) that he or she may discontinue the subject’s participation at any time without penalty or loss of benefits to which the subject is otherwise entitled (21 CFR 50.24(b)). If a LAR or family member is told about the clinical investigation and the subject's condition improves, the subject is also to be informed as soon as feasible.
5. Are there any risks to the patient?
There is always potential for risks associated with both the lifesaving operation due that patients will undergo due to their traumatic injuries and also the use of any investigational product when enrolled in a study. There may be potential risks with the use of the foam injected prior to the surgical procedure. The potential risks of your life saving operation have been identified and could include:
- Adverse biological reaction or toxicity
- Unnecessary surgery
- Ongoing hemorrhage or blood loss
- Compromised cardiac or respiratory function
- Inhaling fluid into the lungs or choking on vomit
- Difficulty breathing
- Damage to organs, tissue or vessels
- Potential loss of pregnancy
- Organ Failure
The potential risks of the use of ResQFoam have been identified and could include:
- Complications related to the abdominal incision for foam injection
- Delay in getting to surgery
- Elevated pressure in your abdomen which may negatively impact your survival from your injury
- Carbon Dioxide Embolism (the accidental injection of carbon dioxide into the veins which may result in the blockage in the cardiovascular system)
- Requiring surgery when you may not have needed a surgical procedure
- Injury to bowel which may require additional standard surgical intervention
- Damage to organs, tissue or vessels
- Adverse biological reaction or toxicity
There might be additional risks which are currently unknown. There are also potential risks associated with your injury and subsequent surgical procedure(s) which would be performed whether you are in the study or not. These specific risks will be discussed with you by your trauma surgery physicians.
A committee composed of physicians and study officials will review data after every patient to assess for the potential of harm. If this committee feels that patients are being harmed by the study, the study will be halted at their recommendation.
6. How can I opt out of this trial?
If you wish to not participate in this trial, please request an “opt out” bracelet. As many of the patients who will be enrolled in this study will be unconscious or otherwise unable to communicate with the team of surgeons treating them, the bracelet must be worn to indicate that you do not wish to be enrolled in the study. To request an opt-out bracelet, please see the “Opt out of REVIVE Trial” instructions.
Study Opt Out
For people who do not wish to participate in this study, we will provide you an “opt out” bracelet at no cost. A colored, plastic bracelet with the words “RESQFOAM Ø” will indicate to ED staff that the patient should not be considered for the study. To obtain an “opt out” bracelet, please email [email protected] In the email, please include an address to which the bracelet may be sent.