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NCT01531803 · ClinicalTrials.gov registry record · Phase 4
Safety Study of Kedbumin 25% Versus Normal Saline in the Treatment of Post-Surgical Hypovolemia in Pediatric Patients
A Phase 4 study, sponsored by Kedrion S.p.A..
- Terminated
- Registry status
- Phase 4
- Development phase
- 3
- Enrollment target
NCT01531803 is a Phase 4 study that was terminated before completion, run by Kedrion S.p.A.. The registered enrollment target is 3 participants.
The verdict
NCT01531803, a Phase 4 study, was terminated before completion, sponsored by Kedrion S.p.A..
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 3 participants
- Enrollment target
Study Summary
This is a randomized, controlled, open-label clinical trial aimed to evaluate the Safety of Kedbumin 25% Compared to Normal Saline Solution in the Treatment of Post-Surgical Hypovolemia in Pediatric Patients Undergoing Major Elective Surgery. It will be conducted at approximately 5 surgical and pediatric intensive care units (SICU/NICU/PICU) in the US, over a period of 19 months, and the study population will consist of at least 60 male and female pediatric subjects between 0 days and 12 years of age, undergoing cardiac, abdominal, orthopedic or transplant surgery with an approximately equal number of subjects (n=10 to 25) in three of the four age groups: (29 days to 23 months), (2 to 5 years 11 months) and (6 years to 12 years) cohorts.
Interventions
- DRUG Normal Saline Solution
- DRUG Kedbumin 25%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2015-02-05 |
| Est. Completion | 2015-07-15 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01531803
The ClinicalTrials.gov registry entry for NCT01531803 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kedrion S.p.A., which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Normal Saline Solution is the first listed.
NCT01531803 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01531803 about?
NCT01531803 is a clinical study titled "Safety Study of Kedbumin 25% Versus Normal Saline in the Treatment of Post-Surgical Hypovolemia in Pediatric Patients". This is a randomized, controlled, open-label clinical trial aimed to evaluate the Safety of Kedbumin 25% Compared to Normal Saline Solution in the Treatment of Post-Surgical Hypovolemia in Pediatric Patients Undergoing Major Elective Surgery. It will be conducted at approximately 5 surgical and pedi...
What is the current status of trial NCT01531803?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 3 participants. The study started on 2015-02-05. Estimated completion is 2015-07-15.
What interventions are being tested in trial NCT01531803?
The interventions under investigation include: Normal Saline Solution (DRUG), Kedbumin 25% (DRUG).
Who is sponsoring clinical trial NCT01531803?
This trial is sponsored by Kedrion S.p.A., which has 8 total clinical trials registered on ClinicalTrials.gov.
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