The Correlation Between The New Sepsis Scores - SOFA, Quick SOFA and Calibrated Automated Thrombogram Values

• Sponsor: HaEmek Medical Center, Israel (Other)
• Overall Status: Completed
• CT.gov ID: NCT02953002
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Actual Duration (Months): 55.5
• Patients Per Site Per Month: 3.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sepsis; Coagulopathy	Device: Calibrated Automated Thrombogram (CAT)

Study Design

• Study Type: Observational
• Anticipated Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Correlation Between The New Sepsis Scores - SOFA, Quick SOFA and Calibrated Automated Thrombogram Values
• Actual Study Start Date: Jan 17, 2017
• Actual Primary Completion Date: Sep 1, 2021
• Actual Study Completion Date: Sep 1, 2021

Outcome Measures

Primary Outcome Measures

1. correlation between sofa score and thrombin generation [one week]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• age above 18

• sepsis diagnosis

Exclusion Criteria:

• oncology patient.

• anticoagulant treatment

• pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emek medical center	Afula		Israel

Sponsors and Collaborators

• HaEmek Medical Center, Israel

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Elias mazen, professor, HaEmek Medical Center, Israel
• ClinicalTrials.gov Identifier: NCT02953002
• Other Study ID Numbers: EMC131-16
• First Posted: Nov 2, 2016
• Last Update Posted: Aug 3, 2022
• Last Verified: Aug 1, 2022

• Additional relevant MeSH terms: Sepsis; Toxemia

Study Results

No Results Posted as of Aug 3, 2022