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Observational Study of the Use of octaplasLG®.

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ClinicalTrials.gov Identifier: NCT03369314
Recruitment Status : Recruiting
First Posted : December 12, 2017
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Thrombotic Thrombocytopenic Purpura 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.


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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Observational, Real-life Study of the Use of octaplasLG®.
Actual Study Start Date : March 2, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020


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®




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03369314


Contacts
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Contact: Mikaela Grupp 866-337-1868 ctgov@clinicalresearchmgt.com

Locations
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France
CHU Angers Not yet recruiting
Angers, France, 49933
CH Henri Duffaut Not yet recruiting
Avignon, France, 84902
Hôpital de La Cavale Blanche Recruiting
Brest, France, 29019
CHU de Caen Not yet recruiting
Caen, France, 14003
Infirmerie Protestante de Lyon Recruiting
Caluire-et-Cuire, France, 69641
CHU Clermont Ferrand Hopital Gabriel Montpied Not yet recruiting
Clermont-Ferrand, France, 63000
APHP Hopital de Kremlin Bicêtre Not yet recruiting
Le Kremlin-Bicêtre, France, 94275
CHU Dupuytren Not yet recruiting
Limoges, France, 87000
Hospices Civils de Lyon Hôpital Edouard Herriot Recruiting
Lyon, France, 67347
Hôpital d'enfants de la Timone Not yet recruiting
Marseille, France, 13385
Hôpital de la Conception Recruiting
Marseille, France, 13385
APHP Hopital Saint Antoine Not yet recruiting
Paris, France, 75012
APHP Hopital Pitié salpêtrière Not yet recruiting
Paris, France, 75651
APHP Hopital Cochin Recruiting
Paris, France
CHU Hôpitaux de Rouen Recruiting
Rouen, France, 76031
CHU Réunion Hôpital Felix Guillon Not yet recruiting
Saint-Denis, France, 97405
CHU SUD Réunion Site Saint Pierre Not yet recruiting
Saint-Pierre, France, 97448
CHRU Hôpital Nord Recruiting
Saint-Étienne, France, 42055
Hôpital Foch Recruiting
Suresnes, France, 92150
CHRU Bretonneau Recruiting
Tours, France, 37000
CHU de Nancy Not yet recruiting
Vandœuvre-lès-Nancy, France, 54511
Sponsors and Collaborators
Octapharma

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Responsible Party: Octapharma
ClinicalTrials.gov Identifier: NCT03369314     History of Changes
Other Study ID Numbers: TMA POOL
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Purpura
Purpura, Thrombocytopenic
Purpura, Thrombotic Thrombocytopenic
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Immune System Diseases
Thrombophilia