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NCT Number: NCT03369314

Observational 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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

CH Henri Duffaut, Avignon, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Patient's refusal to participate

Treatment and study plan

OctaplasLG®

Drug

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

Primary outcomes

  1. Indication for the transfusion of octaplasLG®

    Time frame: From start of treatment to 24 hours following treatment with octaplasLG®

    Indication for the transfusion of octaplasLG®

  2. Degree of urgency - Ordering department of octaplasLG®

    Time frame: From start of treatment to 24 hours following treatment with octaplasLG®

    Degree of urgency - Ordering department of octaplasLG®

  3. Characteristics of the plasma infusions performed (transfusion or PE, administration rate, volume, date)

    Time frame: From start of treatment to 24 hours following treatment with octaplasLG®

    Characteristics of the plasma infusions performed (transfusion or PE, administration rate, volume, date)

  4. Patient characteristics (socio-demographic criteria, blood group, dominant pathology, co-morbidities including allergies, prior treatments)

    Time frame: 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)

  5. Number of iso-group and/or compatible units administered for octaplasLG®

    Time frame: From start of treatment to 24 hours following treatment with octaplasLG®

    Number of iso-group and/or compatible units administered for octaplasLG®

Secondary outcomes

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

    Time frame: 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.).

  2. 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)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Octapharma

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Dec 12, 2017
Registry last updated
Mar 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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