Observational Study of the Use of octaplasLG®.

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

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.

Study Overview

• Status: Completed
• Conditions: Thrombotic Thrombocytopenic Purpura
• Intervention / Treatment: Drug: octaplasLG®

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 Type: Observational
• Enrollment (Actual): 263

Contacts and Locations

Study Locations

• France
  • Avignon, France, 84902
    • CH Henri Duffaut
  • Brest, France, 29019
    • Hôpital de la Cavale Blanche
  • Bron, France, 69500
    • Hôpital Louis Pradel
  • Caluire-et-Cuire, France, 69641
    • Infirmerie Protestante de Lyon
  • Lyon, France, 67347
    • Hospices Civils de Lyon Hôpital Edouard Herriot
  • Marseille, France, 13385
    • Hôpital de la Conception
  • Paris, France
    • APHP Hôpital Cochin
  • Paris, France, 75651
    • APHP Hôpital Pitié Salpêtrière
  • Rouen, France, 76031
    • CHU hopitaux de rouen
  • Saint-Étienne, France, 42055
    • CHRU Hôpital Nord
  • Suresnes, France, 92150
    • Hopital Foch
  • Toulouse, France, 31076
    • Clinique Pasteur
  • Tours, France, 37000
    • CHRU Bretonneau
  • Vandœuvre-lès-Nancy, France, 54511
    • CHU de Nancy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Analyses will be carried out on all patients included, i.e. who have received at least one unit of octaplasLG®. This population will be stratified based on the different product indications.

For the population defined as that of patients with TTP, only those patients for whom the investigator has indicated a confirmed diagnosis of idiopathic TTP will be included in the efficacy analysis (see secondary objective).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients Receiving octaplasLG®; The data will be collected in all patients who have received at least one infusion of octaplasLG®	Drug: octaplasLG®; Data will be collected in all patients who have received at least one infusion of octaplasLG®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Indication for the transfusion of octaplasLG®	Indication for the transfusion of octaplasLG®	From start of treatment to 24 hours following treatment with octaplasLG®
Degree of urgency - Ordering department of octaplasLG®	Degree of urgency - Ordering department of octaplasLG®	From start of treatment to 24 hours following treatment with octaplasLG®
Characteristics of the plasma infusions performed (transfusion or PE, administration rate, volume, date)	Characteristics of the plasma infusions performed (transfusion or PE, administration rate, volume, date)	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)	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®
Number of iso-group and/or compatible units administered for octaplasLG®	Number of iso-group and/or compatible units administered for octaplasLG®	From start of treatment to 24 hours following treatment with octaplasLG®

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerance of octaplasLG®: Adverse effects (with notion of Severity and Imputability, time to onset/start of infusion) associated with the plasma	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.).	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)	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®

Collaborators and Investigators

• Sponsor: Octapharma

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 2, 2018
• Primary Completion (ACTUAL): January 14, 2021
• Study Completion (ACTUAL): January 14, 2021

Study Registration Dates

• First Submitted: November 30, 2017
• First Submitted That Met QC Criteria: December 5, 2017
• First Posted (ACTUAL): December 12, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 19, 2021
• Last Update Submitted That Met QC Criteria: March 18, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Hematologic Diseases; Hemorrhage; Blood Coagulation Disorders; Skin Manifestations; Thrombocytopenia; Blood Platelet Disorders; Thrombophilia; Thrombotic Microangiopathies; Purpura; Purpura, Thrombocytopenic; Purpura, Thrombotic Thrombocytopenic
• Other Study ID Numbers: TMA POOL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No