Observational Study of the Use of octaplasLG .

  • STATUS
    Recruiting
  • participants needed
    100
  • sponsor
    Octapharma
Updated on 19 January 2021

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.

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.

Details
Treatment OctaplasLG®
Clinical Study IdentifierNCT03369314
SponsorOctapharma
Last Modified on19 January 2021

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