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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000427-27 | EudraCT Number |
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| Name | Class |
|---|---|
| Octapharma | INDUSTRY |
| University of Iceland | OTHER |
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Efficacy and safety of OctaplasLG® administration vs. crystalloids (standard) in patients with septic shock - a randomized, controlled, open-label investigator-initiated pilot trial
This is a single center, randomized (1:1, active : standard of care), controlled, open-label, investigator-initiated pilot phase IIa trial in patients with septic shock investigating the efficacy and safety of administrating OctaplasLG® as compared to crystalloids, such as Ringer-Acetate (standard of care) in a total of 40 patients.
40 patients will be enrolled:
All patients will be treated according to the standard ICU care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OctaplasLG | Active Comparator | OctaplasLG® is an industrial donor plasma product pooled from 630 -1520 single donor units. It possesses unique features when compared to standard FFP, such as having a standardized concentration of natural pro- and anti-coagulation factors, a standardized volume as well as being pathogen-free.12 Most importantly, the manufacturing method of OctaplasLG® removes immune complexes and cells in several steps of microfiltration. The manufacturing process also inactivates viral, bacterial and prion pathogen by immune neutralization, solvent-detergent treatment and a prion specific ligand affinity chromatography step. |
|
| Ringer-Acetate | Placebo Comparator | standard of care resuscitation fluid Ringer-acetate is a mixture of electrolytes in water to a slightly hypotonic solution. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OctaplasLG | Drug | OctaplasLG is given as an infusion when resuscitation fluids are required. |
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| Measure | Description | Time Frame |
|---|---|---|
| Microscan at 24 hours | Change in microvascular perfusion from baseline to 24 hours after inclusion as evaluated by sidestream darkfield (SDF; MicroVision Medical, Amsterdam, The Netherlands) imaging technique. | 24 hours after baseline |
| Biomarkers at 24 hours | Change in biomarkers indicative of endothelial activation and damage (sE-selectin, syndecan-1, thrombomodulin, VEGFR1, VEGF, nucleosomes) from baseline to 24 hours after inclusion. | 24 hours after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 24 hour mortality | Difference in 24 hours mortality between patients receiving active treatment (OctaplasLG®) and standard of care (crystalloids such as Ringer-Acetate). | 24 hours after inclusion |
| 7 day mortality |
| Measure | Description | Time Frame |
|---|---|---|
| Sepsis-related organ failure assessment (SOFA) | Worst score in a 24 hour period | At 24 hours, 48 hours, 72 hours and at day 7 after baseline |
| Thrombelastograph (TEG) maximum amplitude at 24 hours | Measuring the maximum amplitude (MA) in mm with TEG |
Inclusion Criteria:
Adult intensive care patients (age ≥ 18 years) AND
Sepsis, defined as life-threatening organ dysfunction caused by a dysregulated host response to infection AND
Quick SOFA (qSOFA) with two or more of
Septic shock, defined as a clinical construct of sepsis with persisting hypotension requiring vasopressors to maintain MAP ≥65 mm Hg and having a serum lactate level >2 mmol/L despite adequate volume resuscitation AND
Requiring infusion of noradrenalin 0.10 mcg/kg/min or more to maintain blood pressure AND
Respiratory failure requiring intubation and mechanical ventilation
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Niels E Clausen | Bispebjerg and Frederiksberg Hospitals, Capitol Region of Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICU Bispebjerg Hospital | Copenhagen | 2200 | Denmark |
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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| ID | Term |
|---|---|
| C028570 | Ringer's acetate |
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| Ringer-Acetate | Drug | Ringer-acetate is given as an infusion when resuscitation fluids are required. |
|
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Difference in 7 day mortality between patients receiving active treatment (OctaplasLG®) and standard of care (crystalloids such as Ringer-Acetate).
| 7 days after inclusion |
| 30 day mortality | Difference in 30 day mortality between patients receiving active treatment (OctaplasLG®) and standard of care (crystalloids such as Ringer-Acetate). | 30 days after inclusion |
| 90 day mortality | Difference in 90 day mortality between patients receiving active treatment (OctaplasLG®) and standard of care (crystalloids such as Ringer-Acetate). | 90 days after inclusion |
| Length of stay in the ICU | The number of days in the ICU after inclusion | Days, assessed at 30-days and 90-days |
| Days on vasopressors | The number of days on vasopressors after inclusion | Days, assessed at 30-days and 90-days |
| Days on ventilator | The number of days on vasopressors after inclusion | Days, assessed at 30-days and 90-days |
| Transfusion requirements | Bleeding requiring > 2 RBC / day | For the first 7 days after inclusion |
| Serious Adverse Reactions at 72 hours | Severe adverse reactions, defined as symptomatic thromboembolism and TACO/TRALI | For the first 72 hours after inclusion |
| Serious Adverse Reactions at day 30 | Severe adverse reactions, defined as symptomatic thromboembolism and TACO/TRALI | At day 30 after inclusion |
| Oxygenation | As evaluated by the PaO2/FiO2-ratio during the ICU stay | At 24 hours, 48 hours, 72 hours and at day 7 after baseline |
| RIFLE criteria: Risk, Injury, and Failure, Loss and End-stage kidney disease | Acute Kidney Injury according to RIFLE criteria | For the first 7 days in the ICU |
| Renal Replacement Therapy | recording whether the patient is receiving dialysis or not | For the first 7 days after inclusion |
| At 24 hours after baseline |
| Thrombelastograph (TEG) maximum amplitude at 48 hours | Measuring the maximum amplitude (MA) in mm with TEG | At 48 hours after baseline |
| Thrombelastograph (TEG) maximum amplitude at 72 hours | Measuring the maximum amplitude (MA) in mm with TEG | At 72 hours after baseline |
| Thrombelastograph (TEG) Functional Fibrinogen maximum amplitude at 24 hours | Measuring the maximum amplitude (MA) in mm with TEG Functional Fibrinogen (FF) | At 24 hours after baseline |
| Thrombelastograph (TEG) Functional Fibrinogen maximum amplitude at 48 hours | Measuring the maximum amplitude (MA) in mm with TEG Functional Fibrinogen (FF) | At 48 hours after baseline |
| Thrombelastograph (TEG) Functional Fibrinogen maximum amplitude at 72 hours | Measuring the maximum amplitude (MA) in mm with TEG Functional Fibrinogen (FF) | At 72 hours after baseline |
| Disseminated Intravascular Coagulation (DIC) score | Total score in a 24 hour period based upon platelets, INR, Fibrinogen and D-dimer lab results. | At 24 hours, 48 hours, 72 hours and at day 7 after baseline |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |