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

THE EFFECT OF PLASMA ON THE ENDOTHELIUM IN CRITICAL ILLNESS

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-005682-12-DK

Enrollment

Unknown

Registered

2013-07-03

Start date

2013-07-03

Completion date

Unknown

Last updated

2017-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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: 16.0 Level: LLT Classification code 10054438 Term: Ischemia System Organ Class: 100000004866 MedDRA version: 16.0 Level: LLT Classification code 10019595 Term: Hemorrhage, unspecified System Organ Class: 100000004866 MedDRA version: 16.0 Level: LLT Classification code 10040580 Term: Shock septic System Organ Class: 100000004862 MedD

Interventions

Trade Name: Octaplas Pharmaceutical Form: Solution for infusion INN or Proposed INN: Pooled pathogeninactivated plasma Other descriptive name: HUMAN PLASMA (POOLED AND TREATED FOR VIRUS INACTIVATION)

Eligibility

Sex/Gender

Male

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To describe the effects of plasma and plasma products on endothelial integrity and glycocalyx composition. To show that plasma and/or plasma products might rejuvenate, repair or protect the injured endothelium in critically ill patients thus being potentially valuable adjuncts in the treatment of serious conditions such as sepsis, septic shock, trauma and severe haemorrhage ;Secondary Objective: To answer how the conditions and the time plasma and plasma products are stored in the blood bank influence how these products affect the endothelium, and if perhaps, a revision of current guidelines on storage of these products is required.;Primary end point(s): Change in the level of biomarkers of endothelial dysfunction and glycocalyx degradation as measured by ELISA in plasma/serum samples from subjects. Markers measured are: Syndecan-1, soluble thrombomodulin, soluble e-selectin, sphingosine-1-phosphate, Prothrombin fragment 1,2 (PF1.2), Thrombin-antithrombin complex (TAT), Protein C (PC), activated protein C (aPC), Tissue factor pathway inhibitor (TFPI), Antithrombin (ATIII), coagulation factor XIII (FXIII), Tissue plasminogen activator (tPA), Plasminogen activator inhibitor (PAI-1), D-dimer, INR, sCD40L, TGF-ß, ß -TG, PF4, Sphingosine-1-phosphate, Hgb, Hct, leucocyte count, platelet count, fibrinogen. ;Timepoint(s) of evaluation of this end point: At completion of all experimental sessions	—

Measure

Time frame

Main Objective: To describe the effects of plasma and plasma products on endothelial integrity and glycocalyx composition. To show that plasma and/or plasma products might rejuvenate, repair or protect the injured endothelium in critically ill patients thus being potentially valuable adjuncts in the treatment of serious conditions such as sepsis, septic shock, trauma and severe haemorrhage ;Secondary Objective: To answer how the conditions and the time plasma and plasma products are stored in the blood bank influence how these products affect the endothelium, and if perhaps, a revision of current guidelines on storage of these products is required.;Primary end point(s): Change in the level of biomarkers of endothelial dysfunction and glycocalyx degradation as measured by ELISA in plasma/serum samples from subjects. Markers measured are: Syndecan-1, soluble thrombomodulin, soluble e-selectin, sphingosine-1-phosphate, Prothrombin fragment 1,2 (PF1.2), Thrombin-antithrombin complex (TAT), Protein C (PC), activated protein C (aPC), Tissue factor pathway inhibitor (TFPI), Antithrombin (ATIII), coagulation factor XIII (FXIII), Tissue plasminogen activator (tPA), Plasminogen activator inhibitor (PAI-1), D-dimer, INR, sCD40L, TGF-ß, ß -TG, PF4, Sphingosine-1-phosphate, Hgb, Hct, leucocyte count, platelet count, fibrinogen. ;Timepoint(s) of evaluation of this end point: At completion of all experimental sessions

—

Secondary

Measure	Time frame
Secondary end point(s): Safety: Temperature, heart rate and blood pressure;Timepoint(s) of evaluation of this end point: Before, 1 hour after infusion and 24 hours after each experimental session	—

Countries

Denmark

Contacts

Public ContactMikkel Gybel-Brask

Dept. of Clinical Immunology

4535452032

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026