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Hemostatic Profile of Post COVID-19/Long COVID-19 Patients

Hemostatic Profile of Post COVID-19/Long COVID-19 Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05721066
Acronym
LCV
Enrollment
102
Registered
2023-02-09
Start date
2022-04-12
Completion date
2022-11-15
Last updated
2023-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, Post-acute COVID-19 Syndrome

Keywords

COVID-19, Post-acute COVID-19 Syndrome, Coagulopathy, Fibrinolysis, Thrombosis

Brief summary

The present study aims at assessing long-term hemostatic profile of patients recovered from COVID-19 acute infection that remain asymptomatic (POST-COVID) versus patients with residual symptoms (LONG-COVID) through the employment of a commercially available new generation point-of-care viscoelastic device. The primary endpoint is based upon the hypothesis that patients with residual symptoms maintain an abnormal coagulation profile even after recovery from COVID-19.

Interventions

DIAGNOSTIC_TESTClotPro assessment

Point-of-care viscoelastic assessment of the coagulation profile (extrinsic pathway, intrinsic pathway, fibrinogen contribution, tPA stimulated fibrinolysis)

DIAGNOSTIC_TESTLaboratory analysis

Blood count and standard coagulation tests (INR, aPTT, fibrinogen, D-dimers, antithrombin)

OTHERInterview

Questionnaire from ISS (Istituto Superiore Sanità, the National Health Institute) about the health conditions before the acute COVID-19 infection, the disease (and the hospitalization) details and the eventual health disturbances experienced after the recovery from COVID-19 infection.

Sponsors

IRCCS Policlinico S. Donato
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* age \> 18 years; * recovery from acute COVID-19 infection; * COVID-19 pneumonia that required hospitalization in our Institution; * discharge from the hospital minimum 3 months before the day of the visit; * written consent to participate to the study.

Exclusion criteria

* none.

Design outcomes

Primary

MeasureTime frameDescription
ClotPro EXTESTDay of the visitExtrinsic pathway of the coagulation as measured by the ClotPro (coagulation time CT, seconds; maximum clot firmness, MCF, millimeters)
ClotPro INTESTDay of the visitIntrinsic pathway of the coagulation as measured by the ClotPro (coagulation time CT, seconds; maximum clot firmness, MCF, millimeters)
ClotPro FIBTESTDay of the visitFibrinogen contribution to the overall clot strength as measured by the ClotPro (maximum clot firmness, MCF, millimeters)
ClotPro TPATESTDay of the visitResistance to the fibrinolysis induced by the tPA (tissue plasminogen) as measured by the ClotPro (lysis time, LT, seconds; maximum lysis, ML, %).

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026