Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
LAS-201
Study information
Scientific title
Acronym
Study hypothesis
After implementation of a novel technology, Octaplas® LG has the same clinical safety and efficacy profile.
Ethics approval
As the procedures during this observational study do not interfere with the patient's usual treatment and monitoring of treatment, this study is not regarded as a clinical study as defined by EU Directive 2001/20/EC. Therefore approval by an Independent Ethical Committee and an Institutional Review Board is not required.
Study design
Non-interventional, sequential cohort, observational, open, prospective, multi-centre study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Plasma transfusion in normal clinical practice
Intervention
Before the first treatment with Octaplas® or Octaplas® LG, the physician will record the available baseline characteristics such as gender, date of birth, weight, blood group, diagnosis, and indication for use of plasma. Details of any plasma-derived blood or blood products given 24 hours before, during or within 48 hours after the treatment with Octaplas® or Octaplas® LG will also be documented.
Details of all Octaplas® or Octaplas® LG infusions will be recorded (date, times of start and end, batch number(s), number of bags, and transfusion volume). Whether the use of Octaplas® or Octaplas® LG is considered by the physician to be successful (Yes/No question) will be recorded, and the reason for the positive or negative assessment will be documented, together with any additional information that may be relevant. If any laboratory tests are done to assess the therapeutic effect of Octaplas® or Octaplas® LG, including but not limited to the international normalised ratio (INR), these will also be recorded. No investigations must be initiated for the purpose of this non-interventional trial. Details of any adverse drug reactions will also be recorded.
Intervention type
Drug
Phase
Not Specified
Drug names
Octaplas®, Octaplas® LG
Primary outcome measures
To observe the usage of the current product Octaplas® and the product with an additional chromatography step Octaplas® LG under normal clinical conditions to ascertain if there are any differences in patients outcomes with respect to effectiveness and tolerability.
The effectiveness of Octaplas® and Octaplas® LG will be an objective assessment by the physician based on clinical or laboratory parameters relevant for the indication of whether the use of the product was successful or not. The tolerability will be evaluated on the basis of the number, nature, type and severity of adverse drug reactions (ADR). At the end of the study methods of descriptive statistics will be used to compare the effectiveness and tolerability of Octaplas® and Octaplas® LG.
Secondary outcome measures
No secondary outcome measures.
Overall trial start date
01/08/2008
Overall trial end date
30/06/2009
Reason abandoned
Eligibility
Participant inclusion criteria
Patients of any age who require a transfusion with Octaplas®/Octaplas® LG are eligible for study enrolment.
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
120
Participant exclusion criteria
1. Known relative contraindications such as latent or apparent cardial decompensation, hypervolaemia, hyperhydration, lung oedema and selective serum IgA deficiency
2. Known absolute contraindications such as hypersensitive against plasma proteins and antibodies against IgA
Recruitment start date
01/08/2008
Recruitment end date
30/06/2009
Locations
Countries of recruitment
Germany
Trial participating centre
Elisabeth-Selbert-Strasse 11
Langenfeld
40764
Germany
Funders
Funder type
Industry
Funder name
Octapharma GmbH (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary