deltatrials
Terminated PHASE3 INTERVENTIONAL 3-arm NCT00316017

Hypertonic Resuscitation Following Traumatic Injury

Phase 3 Study of Hypertonic Resuscitation Following Traumatic Injury With Hypovolemic Shock

Sponsor: Defence Research and Development Canada

Conditions Shock, Traumatic
Interventions 0.9% normal saline 7.5% hypertonic saline (HS) 7.5% hypertonic saline/6% Dextran-70 (HSD)
Updated 10 times since 2017 Last updated: Feb 25, 2011 Started: May 31, 2006 Primary completion: Aug 31, 2009 Completion: Aug 31, 2009
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Futility \& potential safety concern (increased early mortality in the HS/HSD arms for those with no PRBC in 1st 24 hr, post-randomization subgp)

This PHASE3 trial investigates Shock, Traumatic and is currently terminated or withdrawn. Defence Research and Development Canada leads this study, which shows 10 recorded versions since 2006 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotTerminated~Feb 2017 – ~Aug 2017 · 6 months · monthly snapshotTerminated~Aug 2017 – ~May 2018 · 9 months · monthly snapshotTerminated~May 2018 – ~Jun 2018 · 31 days · monthly snapshotTerminated~Jun 2018 – ~Nov 2020 · 29 months · monthly snapshotTerminated~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshotTerminated~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshotTerminated~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – present · 22 months · monthly snapshotTerminated

Change History

10 versions recorded

  1. Sep 2024 — Present [monthly]

    Terminated PHASE3

  2. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE3

  3. Dec 2021 — Jul 2024 [monthly]

    Terminated PHASE3

  4. Jan 2021 — Dec 2021 [monthly]

    Terminated PHASE3

  5. Nov 2020 — Jan 2021 [monthly]

    Terminated PHASE3

▶ Show 5 earlier versions

  1. Jun 2018 — Nov 2020 [monthly]

    Terminated PHASE3

  2. May 2018 — Jun 2018 [monthly]

    Terminated PHASE3

  3. Aug 2017 — May 2018 [monthly]

    Terminated PHASE3

  4. Feb 2017 — Aug 2017 [monthly]

    Terminated PHASE3

  5. Jan 2017 — Feb 2017 [monthly]

    Terminated PHASE3

    First recorded

May 2006

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Defence Research and Development Canada
  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institute of Neurological Disorders and Stroke (NINDS)
  • The Institute of Circulatory and Respiratory Health (ICRH)
  • University of Washington
Data source: University of Washington

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations