A comparison of safety, tolerability and efficacy of universal plasma (Uniplas™ LG) versus standard S/D plasma (Octaplas™ LG) in healthy volunteers: a randomised, double-blind, cross-over trial

Completed

• Conditions: Safety/tolerability (haemolytic transfusion reaction) after transfusion of Uniplas™ LG; Not Applicable

• Registration Number: ISRCTN09913683
• Lead Sponsor: Octapharma AG (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-14
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.