“Efficacy and safety of OctaplasLG® administration vs. crystalloids (standard) in patients with septic shock – a randomized, controlled, open-label investigator-initiated pilot trial”

Vasculopathic Injury and Plasma as Endothelial Rescue in septic shock (SHOCK) trial - VIPER-SHOCK

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000427-27-DK

Enrollment

Registered

2017-02-01

Start date

2017-03-30

Completion date

Unknown

Last updated

2019-11-25

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

Conditions

Patients with septic shock admitted to the intensive care unit. MedDRA version: 19.1 Level: PT Classification code 10040070 Term: Septic shock System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: OctaplasLG Pharmaceutical Form: Infusion INN or Proposed INN: Octaplas Other descriptive name: HUMAN PLASMA POOLED AND TREATED FOR VIRUS INA

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria 1. Adult intensive care patients (age = 18 years) AND 2. Sepsis, defined as life-threatening organ dysfunction caused by a dysregulated host response to infection AND 3. Quick SOFA (qSOFA) with two or more of a. Respiratory rate = 22/min b. Altered mentation (Glasgow Coma Scale score 2 mmol/L despite adequate volume resuscitation AND 5. Requiring infusion of noradrenalin 0.10 mcg/kg/min or more to maintain blood pressure AND 6. Respiratory failure requiring intubation and mechanical ventilation 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: Exclusion criteria Patients are not eligible for inclusion in this trial if they fulfil one or more of the following criteria: 1. Documented refusal of blood transfusion OR 2. Treatment with GPIIb/IIIa inhibitors < 24h from screening OR 3. Withdrawal from active therapy OR 4. Known IgA deficiency with documented antibodies against IgA OR 5. Known hypersensitivity to OctaplasLG®: the active substance, any of the excipients (Sodium citrate dihydrate, Sodium dihydrogenphosphate dihydrate or Glycine) or residues from the manufacturing process (Tri (N-Butyl) Phosphate (TNBP) and Octoxynol (Triton X-100)) OR 6. Known severe deficiencies of protein S OR 7. Pregnancy (non-pregnancy confirmed by patient being postmenopausal or having a negative urine-hCG) OR 8. Previously within 30 days included in an interventional trial OR 9. Severe cirrhotic hepatic failure with expected need for treatment with terlipressin

Design outcomes

Primary

Measure	Time frame
Main Objective: Efficacy of OctaplasLG® administration as compared to crystalloids (standard of care) in patients with septic shock;Secondary Objective: Safety of OctaplasLG®administration as compared to crystalloids (standard of care) in patients with septic shock; Primary end point(s): Primary endpoints • Change in microvascular perfusion from baseline to 24 hours after inclusion as evaluated by sidestream darkfield (SDF; MicroVision Medical, Amsterdam, The Netherlands) imaging technique. • Change in biomarkers indicative of endothelial activation and damage (sE-selectin, syndecan-1, thrombomodulin, VEGFR1, VEGF, nucleosomes) from baseline to 24 hours after inclusion. ;Timepoint(s) of evaluation of this end point: 24 hours after inclusion in the trial as compared to baseline (inclusion)	—

Measure

Time frame

Main Objective: Efficacy of OctaplasLG® administration as compared to crystalloids (standard of care) in patients with septic shock;Secondary Objective: Safety of OctaplasLG®administration as compared to crystalloids (standard of care) in patients with septic shock; Primary end point(s): Primary endpoints • Change in microvascular perfusion from baseline to 24 hours after inclusion as evaluated by sidestream darkfield (SDF; MicroVision Medical, Amsterdam, The Netherlands) imaging technique. • Change in biomarkers indicative of endothelial activation and damage (sE-selectin, syndecan-1, thrombomodulin, VEGFR1, VEGF, nucleosomes) from baseline to 24 hours after inclusion. ;Timepoint(s) of evaluation of this end point: 24 hours after inclusion in the trial as compared to baseline (inclusion)

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Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints • Difference in 24 hours, 7, 30 and 90 day mortality between patients receiving active treatment (OctaplasLG®) and standard of care (crystalloids, such as Ringer-Acetate) • Length of stay in the ICU • Days on vasopressors (without vasopressors in ICU) • Days on ventilator (of ventilator-free days in ICU) • Bleeding requiring > 2 RBC / day during the first 7 days • Severe adverse reactions, defined as symptomatic thromboembolism and TACO/TRALI during the first 72 hours and at day 30. • Oxygenation as evaluated by the PaO2/FiO2-ratio during the ICU stay • Acute Kidney Injury (AKI) according to RIFLE Criteria during the first 7 ICU days • Renal replacement therapy, as deemed necessary by the attending physician, during the first 7 days post-randomization. Safety endpoints • Maximal change in SOFA score from baseline to 24, 48 and 72 hours as well as at ICU day 7. • Thrombelastograph maximum amplitude (clot strength) in TEG and Functional Fibrinogen (FF) at 24, 48 and 72 hours as compared to baseline. • Disseminated intravascular coagulation score (DIC) at 24, 48 and 72 hours as well as at ICU day 7. ; Timepoint(s) of evaluation of this end point: Difference in 24 hours, 7, 30 and 90 day mortality between patients receiving active treatment (OctaplasLG®) and standard of care (crystalloids) Other secondary and safety endpoint during the first 72 hours and at day 7 and 30.	—

Measure

Time frame

Secondary end point(s): Secondary endpoints • Difference in 24 hours, 7, 30 and 90 day mortality between patients receiving active treatment (OctaplasLG®) and standard of care (crystalloids, such as Ringer-Acetate) • Length of stay in the ICU • Days on vasopressors (without vasopressors in ICU) • Days on ventilator (of ventilator-free days in ICU) • Bleeding requiring > 2 RBC / day during the first 7 days • Severe adverse reactions, defined as symptomatic thromboembolism and TACO/TRALI during the first 72 hours and at day 30. • Oxygenation as evaluated by the PaO2/FiO2-ratio during the ICU stay • Acute Kidney Injury (AKI) according to RIFLE Criteria during the first 7 ICU days • Renal replacement therapy, as deemed necessary by the attending physician, during the first 7 days post-randomization. Safety endpoints • Maximal change in SOFA score from baseline to 24, 48 and 72 hours as well as at ICU day 7. • Thrombelastograph maximum amplitude (clot strength) in TEG and Functional Fibrinogen (FF) at 24, 48 and 72 hours as compared to baseline. • Disseminated intravascular coagulation score (DIC) at 24, 48 and 72 hours as well as at ICU day 7. ; Timepoint(s) of evaluation of this end point: Difference in 24 hours, 7, 30 and 90 day mortality between patients receiving active treatment (OctaplasLG®) and standard of care (crystalloids) Other secondary and safety endpoint during the first 72 hours and at day 7 and 30.

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Countries

Denmark

Contacts

Public ContactPär I. Johansson

Section for Transfusion Medicine, Capitol Region Blood Bank

per.johansson@regionh.dk4535458587

Outcome results

None listed

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