A sequential cohort study to compare tolerability and efficacy in patients receiving Octaplas® or Octaplas® LG

ISRCTN	ISRCTN60768666
DOI	https://doi.org/10.1186/ISRCTN60768666
Protocol serial number	LAS-201
Sponsor	Octapharma GmbH (Germany)
Funder	Octapharma GmbH (Germany)

Submission date: 22/10/2008
Registration date: 30/10/2008
Last edited: 30/10/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Susanne Seeger
Scientific

Elisabeth-Selbert-Strasse 11
Langenfeld
40764
Germany

Study information

Primary study design	Observational
Study design	Non-interventional, sequential cohort, observational, open, prospective, multi-centre study
Secondary study design	Cohort study
Scientific title
Study objectives	After implementation of a novel technology, Octaplas® LG has the same clinical safety and efficacy profile.
Ethics approval(s)	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.
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Octaplas®, Octaplas® LG
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	No secondary outcome measures.
Completion date	30/06/2009

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	All
Target sample size at registration	120
Key inclusion criteria	Patients of any age who require a transfusion with Octaplas®/Octaplas® LG are eligible for study enrolment.
Key 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
Date of first enrolment	01/08/2008
Date of final enrolment	30/06/2009

Locations

Countries of recruitment

Germany

Study participating centre

Elisabeth-Selbert-Strasse 11

Langenfeld
40764
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan