CClinicalTrials.gg
CompletedNCT06695377Updated Nov 19, 2024

Thromboembolic Complications in Mild Covid-19 Cases

An observational study in COVID 19, Thromboembolic and Bleeding Complications and Thromboembolism, Venous, sponsored by Marmara University Pendik Training and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-19.

Sponsored by Marmara University Pendik Training and Research Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
961
Ages
18 Years and older
Sex
All
01

Study summary

The aim of the study is to investigate the frequency of thromboembolic complications and the factors influencing them in COVID-19 cases that did not require hospitalization. For this purpose, patients registered at two different family health centers in Istanbul were retrospectively screened, and their status regarding post-COVID-19 thromboembolic events was recorded. The sociodemographic characteristics, medical history, COVID-19 treatments received, comorbidities, and current medications of all patients were examined and compared with the occurrence of complications.

Read the detailed description

Studies on COVID-19 complications in the literature have predominantly focused on patients treated in hospitals, particularly in intensive care units. Data on patients with mild to moderate symptoms who were followed up on an outpatient basis in primary care are quite limited. Therefore, our research investigated the incidence of thrombotic events within six months following infection in mild to moderate COVID-19 cases and the factors that might influence these events. Records of 961 individuals registered at two different family health centers in Istanbul were reviewed. Patients were contacted by phone, informed about the study, and data regarding their sociodemographic characteristics, medical histories, COVID-19 infection experiences, and medications used were collected. Comparative analyses (Fisher's exact test) and logistic regression tests were conducted.

02

Conditions studied

  • COVID 19
  • Thromboembolic and Bleeding Complications
  • Thromboembolism, Venous
  • Post COVID-19

Keywords

  • COVID 19
  • thromboembolism
  • thromboembolic complications
  • pulmonary embolism
  • deep venous thrombosis
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 961 is above the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Marmara University Pendik Training and Research Hospital is the lead sponsor of 32 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients over the age of 18 who were registered at family health centers in two different districts of Istanbul and had a confirmed COVID-19 infection verified by PCR test between January 1, 2022, and June 30, 2022, were included in the study.

Inclusion criteria

  • Being over 18 years of age
  • Having had a confirmed COVID-19 infection verified by a PCR test
  • Being monitored at a family health center without requiring hospitalization during the COVID-19 course
  • Having at least 6 months elapsed since the infection
  • Availability of the patient's medical records
  • Absence of any language barrier or health issue that would prevent communication with the patient

Exclusion criteria

Exclusion Criteria:

  • Being under 18 years of age
  • Having had less than 6 months since the COVID-19 infection
  • Presence of any condition that prevents communication with the patient
  • Incomplete or missing medical records of the patient
  • History of hospitalization due to COVID-19 infection
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
961 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients with a PCR-confirmed COVID-19 diagnosis who were followed up on an outpatient basis
06

What researchers measure

Primary outcomes

  1. The frequency of thromboembolic complications in COVID-19 patients not requiring hospitalization.

    Patients registered at a family health center were retrospectively reviewed, and those with a history of COVID-19 PCR positivity who had been followed up as outpatients were included. The occurrence of venous or arterial thromboembolism within the first 6 months after infection was recorded from their medical reports, and the frequency was calculated.

    Time frame: january-june 2022

  2. The relationship between patients' comorbidities and the occurrence of thromboembolic events post-COVID.

    The patients' existing chronic conditions from the time of their COVID-19 infection were recorded by reviewing the family medicine system. The presence of chronic diseases was then analyzed in comparison to the occurrence of thrombosis within the first 6 months following COVID-19 infection.

    Time frame: january-june 2022

  3. The relationship between patients' medications and the occurrence of thromboembolic events post-COVID.

    The medications regularly used by patients for their chronic conditions since the time of their COVID-19 infection were noted by reviewing records in the family medicine system. These medications were then analyzed in comparison to the occurrence of thrombosis within the first 6 months following COVID-19 infection.

    Time frame: january-june 2022

07

Study locations

1 site
  • Marmara University Medical School
    İstanbul, Turkey
08

References and documents

Publications

  • Azevedo-Cerqueira A, Torrao Pinheiro P, Oliveira J, Manuel-Marques M, Rocha Neves J. Risk Of Venous Thrombosis In The Primary Care Setting During The Covid-19 Pandemic. Port J Card Thorac Vasc Surg. 2023 Apr 4;30(1):43-47. doi: 10.48729/pjctvs.310. PubMed 37029943 ↗
  • Katsoularis I, Fonseca-Rodriguez O, Farrington P, Jerndal H, Lundevaller EH, Sund M, Lindmark K, Fors Connolly AM. Risks of deep vein thrombosis, pulmonary embolism, and bleeding after covid-19: nationwide self-controlled cases series and matched cohort study. BMJ. 2022 Apr 6;377:e069590. doi: 10.1136/bmj-2021-069590. PubMed 35387772 ↗

Individual participant data

Plan to share: No — The research data may be shared anonymously with researchers if needed.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06695377
Lead sponsor
Marmara University Pendik Training and Research Hospital
Responsible party
Buğu Usanma Koban (MD, PhD, Marmara University Pendik Training and Research Hospital) — Principal investigator
First posted
Nov 19, 2024
Start date
Jan 1, 2022
Primary completion
Jun 30, 2022
Completion
Sep 30, 2022
Last update
Nov 19, 2024

Study contacts

Buğu Usanma Koban
principal investigator · Marmara University Medical Faculty

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion