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REVIVE: Reducing Exsanguination Via In-Vivo Expandable Foam

Study acronym: REVIVE
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion date: Jun 28, 2025 to Oct 31, 2026
    • Start date: Jun 28, 2024 to Aug 7, 2025
    • Study sites: 1 to 2
    • Study completion date: Jul 28, 2025 to Dec 31, 2026
    v16
  2. Trial status: Not Yet Recruiting to Recruitingv15 Show 4 more changesShow less
    • Primary completion date: Oct 1, 2024 to Jun 28, 2025
    • Start date changed from estimate of Oct 1, 2023 to Jun 28, 2024
    • Study completion date: Dec 1, 2024 to Jul 28, 2025
    • Study site revised
  3. Start date: Apr 2023 to Oct 1, 2023v14 Show 4 more changesShow less
    • Primary completion date: Apr 2024 to Oct 1, 2024
    • Study completion date: Sep 2024 to Dec 1, 2024
    • Site contact updated
    • Study arms: 0 to 1
  4. Primary completion date: Aug 2023 to Apr 2024
    • Start date: Jan 2023 to Apr 2023
    • Study completion date: Sep 2023 to Sep 2024
    v13
  5. Start date: Apr 2022 to Jan 2023
    • Site contact updated
    v12
Show 10 earlier versionsHide 10 earlier versions
  1. Primary completion date: Oct 2022 to Aug 2023v11 Show 4 more changesShow less
    • Start date: Nov 2, 2020 to Apr 2022
    • Trial status: Recruiting to Not Yet Recruiting
    • Study completion date: Oct 2022 to Sep 2023
    • Site details revised
  2. Phase: Phase 3 to Not applicable
    • Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 2020 to Nov 2, 2020
    v10
  3. Start date: Jun 2020 to Oct 2020
    • Primary and study completion dates: Jun 2022 to Oct 2022
    v9
  4. Start date: Apr 2020 to Jun 2020
    • Primary and study completion dates: Apr 2022 to Jun 2022
    v8
  5. Start date: Jan 2020 to Apr 2020
    • Primary completion date: Feb 2022 to Apr 2022
    v7
  6. Primary completion date: Dec 2021 to Feb 2022
    • Study completion date: May 2022 to Apr 2022
    • Start date: Dec 2019 to Jan 2020
    v6
  7. Primary completion date: Jun 2019 to Dec 2021
    • Start date: Dec 2018 to Dec 2019
    • Study completion date: Jul 2019 to May 2022
    v5
  8. Phase: Phase 1 to Phase 3v4
  9. Re-verified, no change to tracked fieldsv3
  10. Start date: Jan 2017 to Dec 2018
    • Study completion date: Jul 2019
    • Eligibility criteria expanded, about 54 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT02880163
Lead Sponsor Arsenal Medical, Inc.
Conditions
(from sponsor)		 Hemorrhagic Shock, Trauma, Exsanguinating Hemorrhage, Shock; Traumatic
Related terms Exsanguination, Shock, Hemorrhagic, Shock, Traumatic, Wounds and Injuries
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov