Autopsy report · NCT01531803
Safety Study of Kedbumin 25% Versus Normal Saline in the Treatment of Post-Surgical Hypovolemia in Pediatric Patients
Cause of deathRegulatory or ethics
“Per FDA CBER letter dated July 15, 2015, Kedrion SpA was released from the PMC to perform the study with Kedbumin 25% in pediatric patients.”
Life of this trial
- Registered 3 years before it started.
- Ran for about 5 months before it stopped.
- 3 participants enrolled.
- Results were posted on the registry 5 years 7 months after it ended.
Vital statistics
- Status
- Terminated
- Phase
- Phase 4
- Sponsor
- Kedrion S.p.A.
- Sponsor type
- Industry
- Conditions
- Hypovolemia
- Interventions
- Kedbumin 25%; Normal Saline Solution
- Participants
- 3
- Sites
- 2
- Countries
- United States
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.