Clinical Trial: REVIVE: Reducing Exsanguination Via In‐Vivo Expandable Foam

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title:

Brief Summary: 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.

Detailed Summary:
Sponsor: Arsenal Medical, Inc.

Current Primary Outcome: Change in systolic blood pressure after deployment of ResQFoam over baseline value [ Time Frame: 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. ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Arsenal Medical, Inc.

Dates:
Date Received: August 19, 2016
Date Started: January 2017
Date Completion:
Last Updated: August 23, 2016
Last Verified: August 2016