Observational Study of the Use of octaplasLG®.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

263 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-02

Study Completion Date

2021-01-14

Brief Summary

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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.

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Detailed Description

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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

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Thrombotic Thrombocytopenic Purpura

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients Receiving octaplasLG®

The data will be collected in all patients who have received at least one infusion of octaplasLG®

octaplasLG®

Intervention Type DRUG

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

Interventions

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octaplasLG®

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. The patient is treated with octaplasLG® (receiving at least 1 unit of 200 ml octaplasLG®)
2. 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.