Researchers at the University of Cincinnati (UC) have joined a clinical study of ResQFoam, a device designed to treat deadly abdominal internal bleeding.
UC Medical Centre is one of the few Level-1 Trauma Centres in the US selected to participate in the multicentre REVIVE (reducing exsanguination via in‐vivo expandable foam) study.
ResQFoam is an injectable biomaterial that expands within the abdomen to provide pressure on internal organs to prevent bleeding.
The device provides adequate time to bring the patient into the operating room, where the foam is easily removed before the surgery.
REVIVE study is designed to show the safety, effectiveness, and benefit-risk profile of ResQFoam for the in-hospital treatment of severe internal abdominal bleeding due to injury.
UC Medical Centre College of Medicine general surgery section chief Timothy Pritts is leading the REVIVE clinical trial as principal investigator.
Timothy Pritts said: “We hope to demonstrate that this foam can safely and effectively be used to help save lives, both in the hospital and on the battlefield.”
ResQFoam was developed by the US-based medical technology company Arsenal Medical, with funding support from the US Department of Defence.
In the REVIVE study, patients will receive an abdominal injection of two liquid polymers, which will react when they contact with each other, creating a hydrophobic foam that rapidly expands into the anatomy.
Unlike traditional clinical studies, REVIVE will require physicians to begin experimental emergency treatment without first obtaining informed consent from the patient.
Researchers will make all efforts to contact a family member of the participant to discuss the study and obtain their permission for the patient to be in the study.
Pritts and his team will determine if the incoming patients are eligible for the study AND enrol the patients if they are considered eligible candidates.
The enrolled participants will be closely monitored for the first 30 days of their hospital visit, and their outcomes will be used to determine the risks and benefits of the ResQFoam device.
