Observational Study of the Use of octaplasLG®.

Completed

• Conditions: Thrombotic Thrombocytopenic Purpura
• Interventions: Drug: octaplasLG®

• Registration Number: NCT03369314
• Lead Sponsor: Octapharma

Brief 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.

Study Timeline

• Study First Submitted: 2017-11-30
• Study First Submitted QC: 2017-12-05
• Study First Posted: 2017-12-12
• Study Start: 2018-03-02
• Primary Completion: 2021-01-14
• Study Completion: 2021-01-14
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-18
• Last Update Posted: 2021-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 263

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.

Exclusion Criteria

1. Patient's refusal to participate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients Receiving octaplasLG®	octaplasLG®	The data will be collected in all patients who have received at least one infusion of octaplasLG®

Primary Outcome Measures

Name	Time	Method
Indication for the transfusion of octaplasLG®	From start of treatment to 24 hours following treatment with octaplasLG®	Indication for the transfusion of octaplasLG®
Degree of urgency - Ordering department of octaplasLG®	From start of treatment to 24 hours following treatment with octaplasLG®	Degree of urgency - Ordering department of octaplasLG®
Characteristics of the plasma infusions performed (transfusion or PE, administration rate, volume, date)	From start of treatment to 24 hours following treatment with octaplasLG®	Characteristics of the plasma infusions performed (transfusion or PE, administration rate, volume, date)
Patient characteristics (socio-demographic criteria, blood group, dominant pathology, co-morbidities including allergies, prior treatments)	From start of treatment to 24 hours following treatment with octaplasLG®	Patient characteristics (socio-demographic criteria, blood group, dominant pathology, co-morbidities including allergies, prior treatments)
Number of iso-group and/or compatible units administered for octaplasLG®	From start of treatment to 24 hours following treatment with octaplasLG®	Number of iso-group and/or compatible units administered for octaplasLG®

Secondary Outcome Measures

Name	Time	Method
Tolerance of octaplasLG®: Adverse effects (with notion of Severity and Imputability, time to onset/start of infusion) associated with the plasma	From start of treatment to 24 hours following treatment with octaplasLG®	Tolerance of octaplasLG®: Adverse effects (with notion of Severity and Imputability, time to onset/start of infusion) associated with the plasma including allergic immunological type (e.g. TRALI) and other events (infections, related to the PE procedure (e.g. case of transfusion-associated circulatory overload \[TACO\], citrate reaction, etc.).
Efficacy criteria in the treatment of TTP including time to normalisation of platelet count (time between first PE procedure and a confirmed platelet count > 150 x 109/L on at least 2 consecutive days)	From start of treatment to 24 hours following treatment with octaplasLG®	Efficacy criteria in the treatment of TTP including time to normalisation of platelet count (time between first PE procedure and a confirmed platelet count \> 150 x 109/L on at least 2 consecutive days)

Trial Locations

Locations (14)

Infirmerie Protestante de Lyon; 🇫🇷 Caluire-et-Cuire, France

Clinique Pasteur; 🇫🇷 Toulouse, France

Hôpital de La Cavale Blanche; 🇫🇷 Brest, France

CHRU Hôpital Nord; 🇫🇷 Saint-Étienne, France

Hôpital de la Conception; 🇫🇷 Marseille, France

CHRU Bretonneau; 🇫🇷 Tours, France

APHP Hopital Pitié salpêtrière; 🇫🇷 Paris, France

CHU de Nancy; 🇫🇷 Vandœuvre-lès-Nancy, France

CH Henri Duffaut; 🇫🇷 Avignon, France

Hôpital Louis Pradel; 🇫🇷 Bron, France

Hospices Civils de Lyon Hôpital Edouard Herriot; 🇫🇷 Lyon, France

APHP Hopital Cochin; 🇫🇷 Paris, France

Hôpital Foch; 🇫🇷 Suresnes, France

CHU Hôpitaux de Rouen; 🇫🇷 Rouen, France