Observational Study of the Use of octaplasLG .

  • STATUS
    Recruiting
  • days left to enroll
    8
  • participants needed
    100
  • sponsor
    Octapharma
Updated on 3 February 2020
Investigator
Mikaela Grupp
Primary Contact
CHU Dupuytren (1.2 mi away) Contact
+24 other location

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.

Details
Treatment OctaplasLG®
Clinical Study IdentifierNCT03369314
SponsorOctapharma
Last Modified on3 February 2020

Adding a note
adding personal notes guide

Select a piece of text and start making personal notes.

Eligibility

Yes No Not Sure

Inclusion Criteria

Gender: Male or Female
Do you have THROMBOTIC THROMBOCYTOPENIC PURPURA?
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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.
Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more
Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more
Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

Study

user name

Annotated by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No made yet