Autopsy report · NCT01545635

RETIC Trial: Reversal of Trauma Induced Coagulopathy Using Coagulation Factor Concentrates or Fresh Frozen Plasma

“The Interim analysis (100 patients) revealed a possible harm to patients randomised to the fresh frozen plasma (FFP) treatment arm.”

The sponsor’s own words in the registry.

Life of this trial

• Ran for about 3 years 11 months before it stopped.
• 100 participants enrolled.
• No results are posted on the registry.

Vital statistics

Status

Terminated

Phase

Phase 3

Sponsor

Medical University Innsbruck

Sponsor type

University, hospital or other

Conditions

Major Trauma

Interventions

Fibrinogen concentrate, Prothrombin complex concentrate and FXIII concentrate; Fresh Frozen Plasma blood type 0, A, B and AB

Participants

100

Sites

1

Countries

Austria

Trials that died the same way

• A Prospective, Open Label, Phase 1 Safety Study of Passive Immune Therapy During Acute Ebola Virus Disease Using Transfusion of INTERCEPT Plasma Prepared From Volunteer Donors Who Have Recovered From Ebola Virus Disease
  “The study was terminated on expiry of the frozen and stored plasma components.” (58% match in meaning)
• A Pilot Study Comparing the Safety and Efficacy of Everolimus With Other Medicines in Recipients of ECD/DCD Kidneys
  “Interim results suggested a concern for patient outcomes and safety” (56% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.