Observational Study of the Use of octaplasLG®.
Study Details
Study Description
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 | Phase |
|---|---|---|
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 Design
Arms and Interventions
| Arm | 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®
|
Outcome Measures
Primary Outcome Measures
- Indication for the transfusion of octaplasLG® [From start of treatment to 24 hours following treatment with octaplasLG®]
Indication for the transfusion of octaplasLG®
- Degree of urgency - Ordering department of octaplasLG® [From start of treatment to 24 hours following treatment with octaplasLG®]
Degree of urgency - Ordering department of octaplasLG®
- Characteristics of the plasma infusions performed (transfusion or PE, administration rate, volume, date) [From start of treatment to 24 hours following treatment with octaplasLG®]
Characteristics of the plasma infusions performed (transfusion or PE, administration rate, volume, date)
- 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®]
Patient characteristics (socio-demographic criteria, blood group, dominant pathology, co-morbidities including allergies, prior treatments)
- Number of iso-group and/or compatible units administered for octaplasLG® [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
- 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®]
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.).
- 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®]
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)
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CH Henri Duffaut | Avignon | France | 84902 | |
| 2 | Hôpital de La Cavale Blanche | Brest | France | 29019 | |
| 3 | Hôpital Louis Pradel | Bron | France | 69500 | |
| 4 | Infirmerie Protestante de Lyon | Caluire-et-Cuire | France | 69641 | |
| 5 | Hospices Civils de Lyon Hôpital Edouard Herriot | Lyon | France | 67347 | |
| 6 | Hôpital de la Conception | Marseille | France | 13385 | |
| 7 | APHP Hopital Pitié salpêtrière | Paris | France | 75651 | |
| 8 | APHP Hopital Cochin | Paris | France | ||
| 9 | CHU Hôpitaux de Rouen | Rouen | France | 76031 | |
| 10 | CHRU Hôpital Nord | Saint-Étienne | France | 42055 | |
| 11 | Hôpital Foch | Suresnes | France | 92150 | |
| 12 | Clinique Pasteur | Toulouse | France | 31076 | |
| 13 | CHRU Bretonneau | Tours | France | 37000 | |
| 14 | CHU de Nancy | Vandœuvre-lès-Nancy | France | 54511 |
Sponsors and Collaborators
- Octapharma
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TMA POOL