Status:
COMPLETED
Observational Study of the Use of octaplasLG®.
Lead Sponsor:
Octapharma
Conditions:
Thrombotic Thrombocytopenic Purpura
Eligibility:
All Genders
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 h...
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 fo...
Eligibility Criteria
Inclusion
- 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
- 1\) Patient's refusal to participate
Key Trial Info
Start Date :
March 2 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 14 2021
Estimated Enrollment :
263 Patients enrolled
Trial Details
Trial ID
NCT03369314
Start Date
March 2 2018
End Date
January 14 2021
Last Update
March 19 2021
Active Locations (14)
Enter a location and click search to find clinical trials sorted by distance.
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