# Safety Study of Kedbumin 25% Versus Normal Saline in the Treatment of Post-Surgical Hypovolemia in Pediatric Patients

> **NCT01531803** · PHASE4 · TERMINATED · sponsor: **Kedrion S.p.A.** · enrollment: 3 (actual)

## Conditions studied

- Hypovolemia

## Interventions

- **DRUG:** Kedbumin 25%
- **DRUG:** Normal Saline Solution

## Key facts

- **NCT ID:** NCT01531803
- **Lead sponsor:** Kedrion S.p.A.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE4
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2015-02-05
- **Primary completion:** 2015-07-15
- **Final completion:** 2015-07-15
- **Target enrollment:** 3 (ACTUAL)
- **Why stopped:** 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.
- **Last updated:** 2023-11-15

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01531803

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01531803, "Safety Study of Kedbumin 25% Versus Normal Saline in the Treatment of Post-Surgical Hypovolemia in Pediatric Patients". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT01531803. Licensed CC0.

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