Observational Study of the Use of octaplasLG®.

NCT03369314 | Completed FDA Drug

• 1 other identifier: TMA POOL
• Study Type: observational
• Target: 263
• Locations: 1 country
• Sites: 14

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.

Conditions

Thrombotic Thrombocytopenic Purpura

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• 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®

• 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®

Study Arms (1)

Patients Receiving octaplasLG®

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

Drug: octaplasLG®

Interventions

octaplasLG® DRUG

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

Patients Receiving octaplasLG®

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• \) Patient's refusal to participate

Sponsors & Collaborators

• Octapharma: lead

Study Sites (14)

CH Henri Duffaut

Avignon, 84902, France

Location

Hôpital de La Cavale Blanche

Brest, 29019, France

Location

Hôpital Louis Pradel

Bron, 69500, France

Location

Infirmerie Protestante de Lyon

Caluire-et-Cuire, 69641, France

Location

Hospices Civils de Lyon Hôpital Edouard Herriot

Lyon, 67347, France

Location

Hôpital de la Conception

Marseille, 13385, France

Location

APHP Hopital Pitié salpêtrière

Paris, 75651, France

Location

APHP Hopital Cochin

Paris, France

Location

CHU Hôpitaux de Rouen

Rouen, 76031, France

Location

CHRU Hôpital Nord

Saint-Etienne, 42055, France

Location

Hôpital Foch

Suresnes, 92150, France

Location

Clinique Pasteur

Toulouse, 31076, France

Location

CHRU Bretonneau

Tours, 37000, France

Location

CHU de Nancy

Vandœuvre-lès-Nancy, 54511, France

Location

MeSH Terms

Conditions

Purpura, Thrombotic Thrombocytopenic

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Thrombophilia; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2017
• First Posted: December 12, 2017
• Study Start: March 2, 2018
• Primary Completion: January 14, 2021
• Study Completion: January 14, 2021
• Last Updated: March 19, 2021

Record last verified: 2021-03

Locations

FR (14)