NCT04685278

Brief Summary

The detection of antiphospholipid antibodies (aPL) is of interest because of their importance in the pathogenesis of arterial or venous thrombosis and their responsibility for a wide spectrum of clinical manifestations such as infection. The aim of the study was to assess the performance of antiphospholipid antibodies biomarker to predict in- hospital mortality in intensive care unit (ICU) septic patient's.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

October 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 28, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2021

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2021

Completed
Last Updated

December 28, 2020

Status Verified

December 1, 2020

Enrollment Period

4 months

First QC Date

December 14, 2020

Last Update Submit

December 22, 2020

Conditions

Morality

Keywords

anti-phospholipidsepsisintensive care unit

Outcome Measures

Primary Outcomes (1)

  • ICU mortality

    Mortality was defined as death before ICU discharge Multivariate logistic regression modeling will beperformed to found factors associated with higher mortality

    mortality at day 14 of hospitalization

Secondary Outcomes (1)

  • correlation between SOFA score and antiphospholipid antibodies.

    on days 1, 3, 5, 8 and 10 of hospitalization

Interventions

Blood samplesBIOLOGICAL

Blood samples were collected in dry tubes on days 1, 3, 5, 8 and 10 of hospitalization

Eligibility Criteria

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

patients, admitted to the ICU for sepsis

You may qualify if:

  • patients, admitted to the ICU for sepsis and older than 18 years

You may not qualify if:

  • pregnancy
  • clinical history of antiphospholipid syndrome
  • auto-immune diseases
  • immunosuppressive treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Military Hospital of Tunisia

Tunis, 1008, Tunisia

RECRUITING

MeSH Terms

Conditions

Sepsis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Iheb Labbene, Pr

    Military Hospital of Tunis

    STUDY DIRECTOR

Central Study Contacts

Zied Hajjej, Pr

CONTACT

0021620358907hajjej_zied@hotmail.com

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

December 14, 2020

First Posted

December 28, 2020

Study Start

October 1, 2020

Primary Completion

February 5, 2021

Study Completion

February 15, 2021

Last Updated

December 28, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)