Unleash the Mystery of COVID-19 Related Unusual Thrombosis

May 3, 2022 updated by: Mahmoud Ibrahim Yousef, Sohag University

Unusual Pattern of Thrombotic Events in Young Adults Noncritically Ill Patients With COVID-19 May Result From An Un-diagnosed Inherited Form of Thrombophilia

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Sohag, Egypt, 82524
        • Recruiting
        • , Faculty of Medicine, Sohag University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 36 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

- Study group:

At Sohag University Hospitals, we conducted a longitudinal observational study with a 6-month follow-up duration across a fourteen-month period (April 2020 to June 2021). This study enrolled young adult non-critical ill patients (age 18 to 40) with a positive SARS-CoV-2 reverse-transcriptase polymerase chain reaction (rt-PCR) test and unusual sites of thrombotic events. These patients will be compared to young adult non-critical patients presented to our hospital with COVID-19 without thrombosis during the study period.

Patients will be classified into two groups:

  • Group I: COVID-19 patients with unusual thrombosis
  • Group II: COVID-19 patients without unusual thrombosis

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Frequency
Time Frame: Form April 2020 to April 2021
Rates of unusual thrombotic events among non-critically ill young adults' patients with COVID-19
Form April 2020 to April 2021
Thrombosis progression
Time Frame: 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.
First month after diagnosis
Bleeding complications of the UTEs
Time Frame: 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.
First month after diagnosis
Mortality
Time Frame: First month after diagnosis
Death frequency
First month after diagnosis

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Thrombosis recurrence
Time Frame: During 6 months of follow up period
Incidence of thrombosis recurrence after the initial thrombotic event(s)
During 6 months of follow up period
Bleeding
Time Frame: During 6 months of follow up period
Incidence of bleeding (major, minor bleedings)
During 6 months of follow up period
Mortality
Time Frame: During 6 months of follow up period
Death frequency
During 6 months of follow up period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 15, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 2, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Soh-Med-21-04-39

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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