Recombinant Human Antithrombin (ATryn®) in the Treatment of Patients With DIC Associated With Severe Sepsis

Disseminated Intravascular Coagulation Clinical Trial

Official title:

Exploratory Efficacy and Safety, Pharmacokinetics and Dose Finding Study of ATryn® (Antithrombin Alfa) in Patients With Disseminated Intravascular Coagulation Associated With Severe Sepsis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00506519
• Other study ID #: LEO 90010-I21
• Status: Terminated
• Phase: Phase 2
• Start date: July 2007
• Est. completion date: March 2009

Study information

• Verified date: August 2021
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Signed informed consent has been obtained from the patient or his/her legally acceptable representative

• Severe sepsis

• Disseminated intravascular coagulation

Related Conditions & MeSH terms

• Disseminated Intravascular Coagulation
• Sepsis

Intervention

Drug:
• Antithrombin alfa (INN name)

• Control (Standard treatment)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	Day 28
Secondary	Mortality at Day 28		Day 28
Secondary	Mortality at Day 90		Day 90
Secondary	Change From Baseline to Day 6 in SOFA Score Among Survivors on 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.	Baseline to Day 6
Secondary	Change From Baseline to Day 6 in DIC Score Among Survivors on Day 6	Disseminated Intravascular Coagulation (DIC) ranges from 0 to 8 points, the higher the score the worse coagulation/outcome	Baseline to Day 6
Secondary	Days Alive and Out of ICU Day 28	Days alive and out of ICU at day 28 for all patients	Baseline to Day 28
Secondary	Days Alive and Out of Hospital Day 28	Days alive and out of Hospital at day 28 for all patients	Baseline to Day 28
Secondary	Days Alive and Free of Inotrope/Vasopressor Support Day 28	Days alive and free of inotrope/vasopressor at day 28 for all patients	Baseline to Day 28
Secondary	Days Alive and Off Ventilator Day 28	Days alive and free of mechanical ventilation at day 28 for all patients	Baseline to Day 28
Secondary	Days Alive and Free of Need for Renal Replacement Therapy Day 28	Days alive and out of renal replacement therapy at day 28 for all patients	Baseline to Day 28
Secondary	Change From Baseline to Day 6 in Inflammation Marker IL-6		Baseline to Day 6
Secondary	Change From Baseline to Day 6 in Inflammation Marker Procalcitonin		Baseline to Day 6