Observational Study of the Use of octaplasLG®.

Thrombotic Thrombocytopenic Purpura Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03369314
• Other study ID #: TMA POOL
• Status: Completed
• Start date: March 2, 2018
• Est. completion date: January 14, 2021

Study information

• Verified date: March 2021
• Source: Octapharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 263
• Est. completion date: January 14, 2021
• Est. primary completion date: January 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombotic Thrombocytopenic
• Thrombotic Thrombocytopenic Purpura

Intervention

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

Locations

Country	Name	City	State
France	CH Henri Duffaut	Avignon
France	Hôpital de La Cavale Blanche	Brest
France	Hôpital Louis Pradel	Bron
France	Infirmerie Protestante de Lyon	Caluire-et-Cuire
France	Hospices Civils de Lyon Hôpital Edouard Herriot	Lyon
France	Hôpital de la Conception	Marseille
France	APHP Hopital Cochin	Paris
France	APHP Hopital Pitié salpêtrière	Paris
France	CHU Hôpitaux de Rouen	Rouen
France	CHRU Hôpital Nord	Saint-Étienne
France	Hôpital Foch	Suresnes
France	Clinique Pasteur	Toulouse
France	CHRU Bretonneau	Tours
France	CHU de Nancy	Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Octapharma

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Indication for the transfusion of octaplasLG®	Indication for the transfusion of octaplasLG®	From start of treatment to 24 hours following treatment with octaplasLG®
Primary	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®
Primary	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®
Primary	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®
Primary	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	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®
Secondary	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®