Condition category
Not Applicable
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Claudia Walasek


Contact details

Oberlaaerstrasse 235
+43 (0)1 61032 1791

Additional identifiers

EudraCT number

2008-004797-40 number

Protocol/serial number


Study information

Scientific title


Study hypothesis

Comparison of safety, tolerability, and efficacy of universal plasma (Uniplas™ LG) versus standard S/D plasma (Octaplas™ LG) in healthy volunteers.

As of 23/03/2010 this record was updated to include the actual end date of this trial. The initial anticipated end date of this trial was 31/12/2009.

Ethics approval

Local Ethics Committee (Ethikkommission der med. Uni. Wien und des Allg. Krankenhauses der Stadt Wien [AKH]) gave approval on the 20th November 2008 (ref: 395/2008)

Study design

Double-blind block-randomised cross-over phase I study

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Safety/tolerability (haemolytic transfusion reaction) after transfusion of Uniplas™ LG


The treatment day will start with plasmapheresis (600 ml) then transfusion of either Uniplas™ LG or Octaplas™ LG will be randomly assigned. Safety and tolerability will be assessed by clinical and laboratory parameters (haematology, complement activation, immune haematology). Efficacy will be measured by assessing coagulation factors. All these parameters will be collected before and immediately after plasmapheresis (PP), then 15 minutes, 2 hours, 24 hours and 7 days after end of investigational medicinal product (IMP) administration. Treatment sequence is either Uniplas™ LG or Octaplas™ LG or vice versa after a minimal wash out period of 1 month. The overall duration per subject will be 4 months including 3 months follow up and a treatment performed on 2 days.

Intervention type



Phase I

Drug names

Plasma (Uniplas™ LG, Octaplas™ LG)

Primary outcome measure

Haemoglobin (Hb), measured before and immediately after PP and at 15 minutes, 2 hours, 24 hours, 7 days and 3 months after end of IMP administration.

Secondary outcome measures

1. Parameters of haemolysis (haptoglobin, free Hb, indirect bilirubin)
2. Complement activation (CH50, C3c, C4)
3. Immune haematology (direct antiglobulin test [DAT])
4. Haematology (red blood cell [RBC] count, white blood cell [WBC] count, platelets, haematocrit [Hct])
5. Haemostatic parameters (activated partial thromboplastin time [aPTT], prothrombin time [PT], fibrinogen [Fbg], factor II [FII], factor V [FV], factor VII [FVII], factor VIII [FVIII], factor IX [FIX], factor X [FX], factor XI [FXI], protein S, plasmin inhibitor)
6. Changes in viral status over the study period (anti-HIV-1/2, HBsAg, hepatitis B core antigen [anti-HBc], anti-HCV, cytomegalovirus antigen [anti-CMV], hepatitis A virus antibody [anti-HAV], anti-Parvovirus B19)
7. Overall tolerability, vital parameters including body temperature, standard safety laboratory parameters

All primary and secondary endpoints will be measured before and immediately after PP and at 15 minutes/2 hours post-transfusion of IMP. The following extra timepoints will also be used:
1. 24 hours after end of IMP administration: haematology, DAT, complement and coagulation factors
2. 7 days after end of IMP administration: haematology, DAT and complement
3. 3 months after end of IMP administration: haematology, DAT, aPTT, PT, Fbg, and viral markers

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Subject must be capable of understanding and complying with all aspects of the protocol
2. Signed informed consent
3. Fulfil criteria of plasma donors according to a standard questionnaire for blood components donors of the Department of Blood Group Serology and Transfusion Medicine
4. Healthy male or female volunteers greater than or equal to 18 years of age
5. Blood group A, B or AB
6. Women must have a negative pregnancy test (human chorionic gonadotropin [HCG]-based assay)
7. Women must have sufficient methods of contraception (e.g. intrauterine device, oral contraception)
8. Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
9. Standard health insurance

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Pregnancy or lactation
2. Refusal to accept blood products
3. Tattoos within the last 3 months
4. Treatment with fresh frozen plasma (FFP) or blood products in the previous 6 months
5. Subjects with a history of hypersensitivity reaction in general or hypersensitivity to blood products or plasma protein in particular
6. History of angioedema
7. History of coagulation or bleeding disorder or any other known abnormality affecting coagulation, fibrinolysis or platelet function
8. Any other clinically relevant history of disease
9. Any clinically significant abnormal laboratory values including Immmunoglobulin A (IgA) deficiency
10. Seropositivity for hepatitis B surface antigens (HBsAg), hepatitis C virus (HCV), human immunodeficiency virus 1/2 (HIV-1/2) antibodies
11. Symptoms of a clinically relevant illness within 3 weeks before the first trial day
12. Subjects with a history of, or suspected, drug or alcohol abuse
13. Subjects participating in another clinical study currently or during the past 1 month

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Oberlaaerstrasse 235

Sponsor information


Octapharma AG (Switzerland)

Sponsor details

Seidenstrasse 2
+41 (0)55 451 2121

Sponsor type




Funder type


Funder name

Octapharma AG (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes