Observational Study of the Use of octaplasLG .

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  • participants needed
  • sponsor
Updated on 3 February 2020
Mikaela Grupp
Primary Contact
CHU Dupuytren (1.2 mi away) Contact
+24 other location


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.


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.

Treatment OctaplasLG®
Clinical Study IdentifierNCT03369314
Last Modified on3 February 2020

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Inclusion Criteria

Gender: Male or Female
The patient is treated with octaplasLG (receiving at least 1 unit of 200 ml octaplasLG)
In accordance with Reference Methodology MR-003, the patient of legal age must be individually informed through an information sheet, and must not oppose participating in this non-interventional study (with no collection of consent). If the patient is unable to receive the information and express any opposition, family members or the trusted person receive the information and must not oppose the collection of data. For minor patients, one of the holders of parental authority receive the information and must not oppose the collection of data
However, the patient in question will be informed if his/her condition later allows

Exclusion Criteria

Patient's refusal to participate
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Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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