NCT02953002

Brief Summary

In total 200 subjects with diagnosis of sepsis, are planned for inclusion in this trial. After signing an informed consent a blood sample will be obtained from each participant. The investigators will measure the thrombin generation in plasma assessed by the calibrated automated thrombogram (CAT). Sequential Organ Failure Assessment score SOFA will be calculated. The relation between SOFA score and thrombin measurements will be determined.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 2, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

January 17, 2017

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

August 3, 2022

Status Verified

August 1, 2022

Enrollment Period

4.6 years

First QC Date

October 31, 2016

Last Update Submit

August 2, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • correlation between sofa score and thrombin generation

    one week

Interventions

The Calibrated Automated Thrombogram (CAT). Thrombogram describes the concentration of thrombin in clotting plasma and is therefore a general physiologic function test of the thrombotic hemostatic system. The CAT measures thrombotic as well as bleeding tendency.

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

200 men and womens diagnosed with sepsis.

You may qualify if:

  • age above 18
  • sepsis diagnosis

You may not qualify if:

  • oncology patient.
  • anticoagulant treatment
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emek medical center

Afula, Israel

Location

MeSH Terms

Conditions

SepsisHemostatic Disorders

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

October 31, 2016

First Posted

November 2, 2016

Study Start

January 17, 2017

Primary Completion

September 1, 2021

Study Completion

September 1, 2021

Last Updated

August 3, 2022

Record last verified: 2022-08

Locations