NCT03369314

Observational Study of the Use of octaplasLG®.

Observational, Real-life Study of the Use of octaplasLG®.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 263 (actual)
• Sponsor: Octapharma · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This observational study enrolls patients who have received at least one infusion of octaplasLG®. OctaplasLG® will be administered standard of care and observation occurs during the treatment and 24 hours after the end of treatment. Characteristics of the use of octaplasLG®, tolerance criteria, and efficacy criteria will be collected.

Detailed description

Prospective, non-interventional, multicentre study meeting a post-marketing need. The data will be collected in all patients who have received at least one infusion of octaplasLG®. The duration of follow-up is limited to the duration of treatment with octaplasLG® plus 24 h of monitoring after cessation of treatment. Characteristics of the use of octaplasLG® (indication for the transfusion, degree of urgency, characteristics of plasma infusions, patient characteristics, number of iso-group and/or compatible units administered, tolerance criteria (adverse effects), and efficacy criteria (for patients with confirmed diagnosis of TTP--time to normalization of platelet count) will be collected.

Conditions

• Thrombotic Thrombocytopenic Purpura

Interventions

Type	Name	Description
DRUG	octaplasLG®	Data will be collected in all patients who have received at least one infusion of octaplasLG®

Timeline

• Start date: 2018-03-02
• Primary completion: 2021-01-14
• Completion: 2021-01-14
• First posted: 2017-12-12
• Last updated: 2021-03-19

Locations

14 sites across 1 country: France

Regulatory

• FDA-regulated drug study