NCT02050841

Octaplas Pediatric Plasma Replacement Trial

An Open-label, Multicenter, Post-Marketing Requirement (PMR) Study to Investigate the Safety, Tolerability and Efficacy of Octaplas in the Management of Pediatric Patients Who Require Replacement of Multiple Coagulation Factors.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Octapharma · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the safety, tolerability and efficacy of octaplas in pediatric patients who require replacement of multiple coagulation factors. Replacement of multiple coagulation factors in pediatric patients with acquired deficiencies due to liver disease and/or in pediatric patients requiring cardiac surgery or liver surgery.

Conditions

• Liver Surgery
• Liver Dysfunction
• Coagulopathy
• Cardiac Surgery

Interventions

Type	Name	Description
BIOLOGICAL	octaplas	Octaplas S/D Plasma

Timeline

• Start date: 2014-12-01
• Primary completion: 2017-12-04
• Completion: 2017-12-04
• First posted: 2014-01-31
• Last updated: 2020-06-23
• Results posted: 2019-03-25

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study