Unleash the Mystery of COVID-19 Related Unusual Thrombosis

Sponsor
Sohag University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05068375
Collaborator
(none)
150
Enrollment
1
Location
18.5
Anticipated Duration (Months)
8.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Arterial thrombosis and unusual patterns of thrombotic events in young adults patients with COVID-19 are yet rarely described in this setting and could be underestimated. There is a real need for studies to describe the frequency of unusual thrombotic complications.

Condition or DiseaseIntervention/TreatmentPhase
  • Diagnostic Test: Thrombophilia screening

Detailed Description

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), first identified in Wuhan, China in December of 2019, has become a worldwide pandemic with widespread illness and mortality. Clinical manifestations of Coronavirus disease 2019 (COVID-19) are absent or mild in a substantial proportion of patients who test positive for COVID-19. Although respiratory compromise is the cardinal feature of the disease, early studies have suggested that elevated circulating D-dimer levels are associated with mortality suggesting a distinct coagulation disorder associated with COVID-19. COVID-19 infection is commonly complicated with pro-thrombotic state and endothelial dysfunction.

Recent autopsy studies of COVID-19 patients supported this hypothesis by demonstrating the extensive extracellular fibrin deposition and presence of fibrin thrombi within distended capillaries and small vessels. Observational studies reported an excess of venous thromboembolic events (deep vein thrombosis (DVT), pulmonary embolism (PE)) among patients suffering from Covid-19. Retrospective studies have reported thrombotic rates in excess of 20% to 30%, but the use of prophylactic anticoagulation and duration of treatment were not consistent between studies. Unrecognized PE and pulmonary in situ thrombosis were reported as causes of the high mortality observed among COVID-19 patients. There is currently no clear estimation of the risk of arterial and, in particular, venous thromboembolic complications which depend on local diagnostic and pharmacological preventive strategies. In addition to D-dimer, a prolonged prothrombin time (PT) has been associated with decreased survival and increased need for critical care.

However, arterial thrombosis and unusual patterns of thrombotic events in young adults patients with COVID-19 are yet rarely described in this setting and could be underestimated (9). Thus, there is a real need for studies to describe the frequency of unusual thrombotic complications. Therefore, the purpose of this study will be to explore thromboembolic risk and associated predicting factors in the young adults' cohort of noncritically ill COVID-19 patients which will help to optimize diagnostic, therapeutic, and preventive strategies of COVID-19 related thrombosis.

Study Design

Study Type:
Observational
Anticipated Enrollment :
150 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Unusual Pattern of Thrombotic Events in Young Adults Noncritically Ill Patients With COVID-19 May Result From An Un-diagnosed Inherited Form of Thrombophilia
Actual Study Start Date :
Apr 1, 2020
Anticipated Primary Completion Date :
Oct 15, 2021
Anticipated Study Completion Date :
Oct 15, 2021

Arms and Interventions

ArmIntervention/Treatment
Thrombotic group

Non-critically COVID-19 patients with unusual thrombotic events

Diagnostic Test: Thrombophilia screening
Genetic thrombophilia and acquired thrombophilia screening

Non-thrombotic group

Non-critically COVID-19 patients without thrombotic events

Outcome Measures

Primary Outcome Measures

  1. Frequency [Form April 2020 to April 2021]

    Rates of unusual thrombotic events among non-critically ill young adults' patients with COVID-19

  2. Thrombosis progression [First month after diagnosis]

    Thrombosis progression: Symptomatic extension of a pre-existing thrombus or new symptomatic thrombus not evident on the initial imaging at a second compressive examination.

  3. Bleeding complications of the UTEs [First month after diagnosis]

    Bleeding (major, minor bleedings) I. Major bleeding is defined as frank bleeding contributed to death or associated with a decreasing in hemoglobin ≥2 g/dL, or need a packed red blood cells transfusion ≥2 units, or bleeding at a critical site. II. Non-major bleeding was defined as any symptom or sign of bleeding that did not fit the criteria of major bleeding but fulfilled at least one of the these criteria: leading to hospitalization, or requiring healthcare professional medical intervention, or spurring a face-to-face assessment.

  4. Mortality [First month after diagnosis]

    Death frequency

Secondary Outcome Measures

  1. Thrombosis recurrence [During 6 months of follow up period]

    Incidence of thrombosis recurrence after the initial thrombotic event(s)

  2. Bleeding [During 6 months of follow up period]

    Incidence of bleeding (major, minor bleedings)

  3. Mortality [During 6 months of follow up period]

    Death frequency

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  • non-critically ill young adults' patients with COVID-19 admitted to our hospital will have confirmed unusual thrombotic events and accept recruitment to this study.

After that, we will focus only on previously healthy patients without pre-existing prothrombotic factors and presented with COVID-19 related unusual thrombotic events

Exclusion Criteria:
  • COVID-19 patients below 18 years and above 40 years

  • COVID-19 patients diagnosed as critically ill COVID-19

  • COVID-19 patients with pre-existing diabetes mellitus (DM), hypertension, ischemic heart disease (IHD), valvular heart disease, cardiomyopathy and chronic arrhythmia, dyslipidemia, metabolic syndrome, chronic kidney disease, liver disease, nephrotic syndrome, previous autoimmune disease, and malignancy

  • COVID-19 patients with chronic lung disease or immune compromise

  • COVID-19 pregnant women

  • COVID-19 patient with history of thrombosis/ psychiatric disorders/ drug abuse

  • COVID-19 patient previously diagnosis with congenital thrombophilia

  • COVID-19 patient with drug history could induce thrombosis.

  • COVID-19 patient unwilling to be followed up.

  • Patients are previously diagnosed with one or more risk factors of thrombosis

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1, Faculty of Medicine, Sohag UniversitySohagEgypt82524

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mahmoud Ibrahim Yousef, Assistant Professor MD Phd., Sohag University
ClinicalTrials.gov Identifier:
NCT05068375
Other Study ID Numbers:
  • Soh-Med-21-04-39
First Posted:
Oct 5, 2021
Last Update Posted:
Oct 11, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 11, 2021