Vasculopathic Injury and Plasma as Endothelial Rescue in Septic Shock Trial. VIPER-Sepsis (EudraCT no. 2016-000707-81)

PHASE4TerminatedINTERVENTIONAL
Enrollment

5

Participants

Timeline

Start Date

September 1, 2016

Primary Completion Date

November 8, 2016

Study Completion Date

November 8, 2016

Conditions
Septic Shock
Interventions
DRUG

OctaplasLG®

"OctaplasLG is an donor plasma product pooled from approximately 1000 single donor units. It possesses unique features when compared to standard fresh frozen plasma, such as having standardized concentrations of natural pro- and anti-coagulation factors, a standardized volume as well as being pathogen free. The manufacturing method of OctaplasLG removes immune complexes and cells in several steps of microfiltration in addition to viral, bacterial and prion pathogen inactivation by immune neutralization. OctaplasLG should reduce the inflammatory hit on the endothelium, including the glycocalyx, by having standardized levels of coagulation proteins, which can give more sustainable support to the endothelial regeneration as compared to standard fresh frozen plasma."

DRUG

Ringer-acetat

Crystalloid used as standard of care.

Trial Locations (1)

2400

Intensive Care Unit Bispebjerg Hospital, Copenhagen

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Octapharma

INDUSTRY

lead

Rigshospitalet, Denmark

OTHER