Condition category
Injury, Occupational Diseases, Poisoning
Date applied
22/10/2008
Date assigned
30/10/2008
Last edited
30/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Susanne Seeger

ORCID ID

Contact details

Elisabeth-Selbert-Strasse 11
Langenfeld
40764
Germany

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

Sponsor information

Organisation

Octapharma GmbH (Germany)

Sponsor details

Elisabeth-Selbert-Strasse 11
Langenfeld
40764
Germany

Sponsor type

Industry

Website

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

Publication citations

Additional files

Editorial Notes