NCT05279469

Brief Summary

Evaluating value of D-Dimer blood level of icu admitted patients on admission and 48 hours later as outcome predictor in SARS.COV.2 patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
465

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

June 10, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2022

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 10, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 15, 2022

Completed
Last Updated

March 15, 2022

Status Verified

March 1, 2022

Enrollment Period

9 months

First QC Date

March 10, 2022

Last Update Submit

March 12, 2022

Conditions

Critical IllnessPneumonia, Viral

Keywords

D dimerSARS-COV-2

Outcome Measures

Primary Outcomes (1)

  • 28 days mortality

    Outcomes of ICU stay

    1 month

Secondary Outcomes (1)

  • length of stay and mechanical ventilation

    during ICU stay

Interventions

no intervention, just observational for D-Dimer level in bloodOTHER

observation for basal D-Dimer and 48 hours later D-Dimer in blood for ICU SARS.COV.2 patients

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients in SARS.COV.2 patients in ICU with positive PCR and needing oxygen therapy

You may qualify if:

  • patients of both sex admitted in icu
  • positive PCR
  • requiring oxygen therapy

You may not qualify if:

  • ward patients
  • negative PCR

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ain shams university hospitals

Cairo, Egypt

Location

Faculty of medicine, Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Critical IllnessPneumonia, Viral

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 10, 2022

First Posted

March 15, 2022

Study Start

June 10, 2021

Primary Completion

March 3, 2022

Study Completion

March 9, 2022

Last Updated

March 15, 2022

Record last verified: 2022-03

Locations

EG(2)