Recombinant Human Antithrombin (ATryn®) in the Treatment of Patients With DIC Associated With Severe Sepsis
- Conditions
- Disseminated Intravascular Coagulation
- Interventions
- Drug: Antithrombin alfa (INN name)Drug: Control (Standard treatment)
- Registration Number
- NCT00506519
- Lead Sponsor
- LEO Pharma
- Brief Summary
The primary objective of the study is to explore the efficacy and safety of ATryn® (antithrombin alfa) for the treatment of disseminated intravascular coagulation (DIC) associated with severe sepsis, when administered by continuous intravenous (IV) infusion over five days.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 25
- Signed informed consent has been obtained from the patient or his/her legally acceptable representative
- Severe sepsis
- Disseminated intravascular coagulation
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AT-150 Antithrombin alfa (INN name) Loading dose followed by maintenance IV infusion for 5 days to maintain antithrombin activity at the target level 125-175% AT-250 Antithrombin alfa (INN name) Loading dose followed by maintenance IV infusion for 5 days to maintain antithrombin activity at the target level 225-275% Control Control (Standard treatment) The best standard treatment for the underlying condition only
- Primary Outcome Measures
Name Time Method Patients Alive on Day 28, Having Had an Improvement in the DIC Score (Overt or Non-overt) by at Least 2 Points Between Baseline and Day 6 and Having Had no Worsening of the SOFA Score Between Baseline and Day 6. Day 28 Disseminated Intravascular Coagulation (DIC) ranges from 0 to 8 points, the higher the score the worse coagulation/outcome.
Sepsis-related Organ Failure Assessment (SOFA) is a composite score of scores for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems. Each system is scored from 0 to 4 with a higher score given for worse organ function. The scores are then added together to give a total range from 0 to 24 with a higher score representing a worse outcome.
- Secondary Outcome Measures
Name Time Method Days Alive and Out of Hospital Day 28 Baseline to Day 28 Days alive and out of Hospital at day 28 for all patients
Days Alive and Free of Inotrope/Vasopressor Support Day 28 Baseline to Day 28 Days alive and free of inotrope/vasopressor at day 28 for all patients
Days Alive and Off Ventilator Day 28 Baseline to Day 28 Days alive and free of mechanical ventilation at day 28 for all patients
Days Alive and Free of Need for Renal Replacement Therapy Day 28 Baseline to Day 28 Days alive and out of renal replacement therapy at day 28 for all patients
Change From Baseline to Day 6 in Inflammation Marker IL-6 Baseline to Day 6 Change From Baseline to Day 6 in Inflammation Marker Procalcitonin Baseline to Day 6 Mortality at Day 28 Day 28 Mortality at Day 90 Day 90 Change From Baseline to Day 6 in SOFA Score Among Survivors on Day 6 Baseline to Day 6 Sepsis-related Organ Failure Assessment (SOFA) is a composite score of scores for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems. Each system is scored from 0 to 4 with a higher score given for worse organ function. The scores are then added together to give a total range from 0 to 24 with a higher score representing a worse outcome.
Change From Baseline to Day 6 in DIC Score Among Survivors on Day 6 Baseline to Day 6 Disseminated Intravascular Coagulation (DIC) ranges from 0 to 8 points, the higher the score the worse coagulation/outcome
Days Alive and Out of ICU Day 28 Baseline to Day 28 Days alive and out of ICU at day 28 for all patients