Trial Outcomes & Findings for Sepsis-Associated Purpura Fulminans International Registry - Europe (NCT NCT02238795)

NCT ID: NCT02238795

Last Updated: 2025-05-21

Results Overview

All-cause in-hospital mortality

• Recruitment status: COMPLETED
• Target enrollment: 28 participants
• Primary outcome timeframe: during hospital stay (estimated up to 3 months)
• Results posted on: 2025-05-21

Participant Flow

Participant milestones

Measure	Purpura Fulminans Patients diagnosed with Purpura fulminans in association with sepsis
Overall Study STARTED	28
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Purpura Fulminans Patients diagnosed with Purpura fulminans in association with sepsis
Overall Study Patient without purpura fulminans	1

Baseline Characteristics

Sepsis-Associated Purpura Fulminans International Registry - Europe

Baseline characteristics by cohort

Measure	Purpura Fulminans n=27 Participants Patients with purpura fulminans
Age, Continuous	48.5 years STANDARD_DEVIATION 22.3 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Race/Ethnicity, Customized Ethnic Origin · Caucasian	26 Participants n=5 Participants
Race/Ethnicity, Customized Ethnic Origin · Asian/Pacific islander	1 Participants n=5 Participants
BMI	26.2 kg/m2 STANDARD_DEVIATION 7.1 • n=5 Participants

PRIMARY outcome

Timeframe: during hospital stay (estimated up to 3 months)

Population: One patient had missing data concerned the primary endpoint.

All-cause in-hospital mortality

Outcome measures

Measure	Purpura Fulminans n=26 Participants Patients with purpura fulminans
Mortality	11 Participants

SECONDARY outcome

Timeframe: duration of hospital stay, up to 3 months

Hospital stay (in days), patients were observed through hospital stay as long as it took

Outcome measures

Measure	Purpura Fulminans n=26 Participants Patients with purpura fulminans
Hospital Stay	16 days Interval 4.0 to 57.0

SECONDARY outcome

Timeframe: 7 days

Extent and severity of Purpura fulminans lesions: Number of lesions with purpura fulminans

Outcome measures

Measure	Purpura Fulminans n=16 Participants Patients with purpura fulminans
Extent and Severity of Purpura Fulminans Lesions	6.3 number of lesions Standard Deviation 3.3

SECONDARY outcome

Timeframe: day 7

Mean total Sepsis-related organ failure assessment (SOFA) score at day 7, range 0-24 points, higher scores are worse.

The total SOFA score is the sum of the subscores of central nervous system, cardiovascular system, respiratory system, coagulation, liver and renal function. The range of all subscores is from 0 to 4, with 4 points indicating the worst outcome.

Outcome measures

Measure	Purpura Fulminans n=11 Participants Patients with purpura fulminans
Mean Total Sepsis-related Organ Failure Assessment (SOFA) Score	12.6 score on a scale Standard Deviation 4.7

SECONDARY outcome

Timeframe: until day 7

Administration of Protein C

Outcome measures

Measure	Purpura Fulminans n=27 Participants Patients with purpura fulminans
Protein C	8 Participants

SECONDARY outcome

Timeframe: during ICU stay (estimated up to 3 months)

Duration of hospitalization in an ICU

Outcome measures

Measure	Purpura Fulminans n=26 Participants Patients with purpura fulminans
Duration of ICU Stay	11.5 days Interval 3.0 to 34.0

SECONDARY outcome

Timeframe: during hospital stay (estimated up to 3 months)

Adverse Drug Reaction related to specific PF treatment: Visual nerve damage

Outcome measures

Measure	Purpura Fulminans n=26 Participants Patients with purpura fulminans
Adverse Drug Reactions: Visual Nerve Damage	1 Participants

SECONDARY outcome

Timeframe: during ICU stay

Occurence of Bleeding (Adverse drug reaction)

Outcome measures

Measure	Purpura Fulminans n=26 Participants Patients with purpura fulminans
Adverse Drug Reaction: Bleeding	0 Participants

SECONDARY outcome

Timeframe: during ICU stay

Occurence of thrombotic events (Adverse Drug Reaction)

Outcome measures

Measure	Purpura Fulminans n=26 Participants Patients with purpura fulminans
Adverse Drug Reaction: Thrombotic Events	0 Participants

SECONDARY outcome

Timeframe: during ICU stay

Need for amputation

Outcome measures

Measure	Purpura Fulminans n=26 Participants Patients with purpura fulminans
Amputation	6 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: during ICU stay (estimated up to 3 months)

Vasopressor-free days

Outcome measures

Measure	Purpura Fulminans n=26 Participants Patients with purpura fulminans
Vasopressor Days	6.5 days Interval 3.0 to 10.0

OTHER_PRE_SPECIFIED outcome

Timeframe: during ICU stay (estimated up to 3 months)

Number of ventilator-free days

Outcome measures

Measure	Purpura Fulminans n=26 Participants Patients with purpura fulminans
Ventilator-free Days	6 days Interval 3.0 to 15.0

OTHER_PRE_SPECIFIED outcome

Timeframe: during ICU stay (estimated up to 3 months)

Duration (hours) of renal replacement therapy

Outcome measures

Measure	Purpura Fulminans n=24 Participants Patients with purpura fulminans
Renal Replacement Therapy	7 days Interval 3.0 to 14.0

Adverse Events

Purpura Fulminans

Serious events: 1 serious events

Other events: 0 other events

Deaths: 11 deaths

Serious adverse events

Measure	Purpura Fulminans n=26 participants at risk Patients diagnosed with Purpura fulminans in association with Sepsis; Since this was only a Registry observing Treatment of Purpra fulminans AE reporting was per decision of the investigator, focusing on * Bleeding * Thrombotic events
Nervous system disorders Visual Nerve Damage	3.8% 1/26 • Number of events 1 • during hospital stay (estimated up to 3 months) Adverse event related to PF treatment (reporting as per decision of the investigator) * Bleeding * Thrombotic events

Other adverse events

Adverse event data not reported

Additional Information

Prof. Dr. Frank M. Brunkhorst

Jena University Hospital, Center for Clinical Studies

Phone: +49 3641 939

Email: frank.brunkhorst@med.uni-jena.de

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place