THE EFFECT OF BLOOD PLASMA ON THE INNER SURFACE OF BLOOD VESSELS IN CRITICAL ILLNESS

Phase 1

• Conditions: Pilot study in healthy subjects with a perspective for treating of serious conditions such as sepsis, septic shock, trauma and severe haemorrhage; MedDRA version: 16.0Level: LLTClassification code 10054438Term: IschemiaSystem Organ Class: 100000004866; MedDRA version: 16.0Level: LLTClassification code 10019595Term: Hemorrhage, unspecifiedSystem Organ Class: 100000004866; MedDRA version: 16.0Level: LLTClassification code 10040580Term: Shock septicSystem Organ Class: 100000004862; MedDRA version: 16.0Level: LLTClassification code 10044461Term: TraumaSystem Organ Class: 100000004863; Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

• Registration Number: EUCTR2012-005682-12-DK
• Lead Sponsor: Dept. of Clinical Immunology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-03
• Last Update Posted: 9 January 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

Healthy, non-smoking males over 17 years of age, weight>80 kg. Able and willing to provide informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 8
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Any history or evidence of serious health problems including pulmonary edema or cardiac insufficiency, allergy towards the study medication, plasma proteins or previous reaction to plasma, inability to provide informed consent. IgA deficiency with documented antibody directed against IgA. Severe protein S deficiency or a history of thrombotic events.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified