Platelet Aggregation in COVID-19 Patients

NCT06097429 | Completed

• 1 other identifier: MS.21.07.1596
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Context: Hypercoagulable state associated with COVID-19 is one of the pathologic events that noticed in different waves of COVID-19 pandemics and leads to serious consequences in mortality and morbidity Aim: To evaluate platelet aggregation using light-transmission aggregometry and adenosine diphosphate (ADP) as an agonist in COVID-19 patients. Settings and design: This was prospective cross-sectional study. Patients and methods: Seventy-five individuals were enrolled in this study and divided into two groups, 50 patients with PCR-positive COVID-19 as study group and 25 apparently healthy individual as a control group. All individuals were subjected to full clinical evaluation, CT-chest, laboratory investigations: CBC, INR, LDH, CRP, serum ferritin and platelet aggregation evaluation using light-transmission aggregometry and adenosine diphosphate (ADP) as an agonist

Conditions

COVID-19

Keywords

platelet aggregation; COVID-19; ADP; light-transmission aggregometry

Outcome Measures

Primary Outcomes (1)

• Mortality rate.

  recording from any mortality from the study and the control group

  day 0 to day 30

Secondary Outcomes (3)

• Developing new thromboembolic event as arterial or venous thrombosis

  day 0 to day 30

• Need to invasive mechanical ventilation (MV)

  day 0 to day 30

• Length of hospital stay (days)

  day 0 to day 30

Study Arms (2)

study group

COVID-19 confirmed cases with positive PCR test in the first week of diagnosis

Diagnostic Test: blood sample for platelet aggregation

control group

healthy volunteers, persons with no history nor symptoms suggestive of COVID-19 with negative COVID -19 PCR test and no CT Chest changes suggestive of COVID-19 infection.

Diagnostic Test: blood sample for platelet aggregation

Interventions

blood sample for platelet aggregation DIAGNOSTIC_TEST

evaluate platelet aggregation using light-transmission aggregometry and adenosine diphosphate (ADP)

control group; study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study group: COVID-19 confirmed cases with positive PCR test in the first week of diagnosis with COVID-19 CT changes with any severity grade according to WHO, (2020) Control group: healthy volunteers, persons with no history nor symptoms suggestive of COVID-19 with negative COVID -19 PCR test and no CT Chest changes suggestive of COVID-19 infection. They were also matched with the study group in demographic variables and comorbidities.

You may qualify if:

• Age ≥ 18 years old.

You may not qualify if:

• Patients with thrombocytopenia and thrombocytosis defined as platelet count less than 100,000/ µL, count more than 450,000 / µL respectively
• Patients with hematocrit abnormalities as less than 34% or greater than 55%
• Patients with disseminated intravascular coagulation (DIC)
• Active malignancy
• Liver disease as such chronic hepatitis, cirrhosis or liver cell failure.
• Any hematological disorders as hemophilia or thalassemia.
• Patients on invasive mechanical ventilation as endotracheal intubation and mechanical ventilation itself are factors for having a higher mean platelet volume (MPV) which means that platelets are larger than average which are more adhesive and likely to aggregate in vitro. Patients receiving aspirin, non-steroidal anti-inflammatory drugs, antiplatelet drugs or any other medications that can influence platelet function (14 days prior to blood sample collection)

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Medicine

Al Mansurah, 35516, Egypt

Location

MeSH Terms

Conditions

COVID-19

Interventions

Blood Specimen Collection; Platelet Aggregation

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Hemorheology; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Platelet Activation; Hemostasis

Study Officials

• rehab Ah elmorsey, MD

  Mansoura University, chest medicine departmenr

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: October 24, 2023
• Study Start: July 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: February 1, 2022
• Last Updated: October 24, 2023

Record last verified: 2023-10

Locations

EG (1)