deltatrials
Completed PHASE3 NCT01127477

Study to Obtain Volume Effect and Safety Data on 6 % Hydroxyethyl Starch 130/0.4 in Pediatric and Adult Patients Undergoing Major Elective Surgery

Examination of Volume Effect and Safety of 6 % Hydroxyethyl Starch 130/0.4 in Patients Undergoing Major Elective Surgery - an Uncontrolled, Open-labelled, Multi-centre Study

Sponsor: Fresenius Kabi Japan

Conditions Plasma Volume Substitution (Hypovolemia) Including Massive Hemorrhage
Interventions 1: Hydroxyethyl starch 130/0.4, 6 %
Updated 5 times since 2017 Last updated: Jun 25, 2012 Started: May 31, 2010 Primary completion: Dec 31, 2010 Completion: Dec 31, 2010

Listed as NCT01127477, this PHASE3 trial focuses on Plasma Volume Substitution (Hypovolemia) Including Massive Hemorrhage and remains completed. Sponsored by Fresenius Kabi Japan, it has been updated 5 times since 2010, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Change History

5 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE3

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  3. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE3

  4. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE3

  5. Jan 2017 — Jun 2018 [monthly]

    Completed PHASE3

    First recorded

May 2010

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Fresenius Kabi Japan
Data source: Fresenius Kabi

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

Study Locations

  • • Okayama, Japan
  • • Sapporo, Japan
  • • Tokyo, Japan