Correlation Between Computer Tomography Angiography and D-Dimer Level for the Diagnosis of Pulmonary Embolism

NCT05862220 | Completed

• 1 other identifier: ZH-12-2022-01
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

A blood sample was taken before starting the patients on any thrombolytic treatment. The positivity threshold for D-Dimer was above 250 ng/ml. CTPA was performed after performing blood sampling. Patients with confirmed pulmonary embolisms were admitted to ICU for continued monitoring of vitals, consciousness level, and signs of tissue perfusion. Signs of shock or hemodynamic instability should be observed regularly. Patients were managed in the ICU with anticoagulants by parenteral use. The most commonly used items were Heparin, either Unfractionated (UFH) or low-molecular-weight heparin (LMWH).D-dimer levels can leverage to detect PE. D-dimer levels can help in guiding the option of CTPA and the initiation of treatment for patients with suspected PE.

Conditions

D-Dimer as an Early Detector of Pulmonary Embolism

Keywords

D-Dimer, Pulmonary, Embolism, CTPA.

Outcome Measures

Primary Outcomes (1)

• the robustness of d-dimer testing for PE compared to CTPA and identify the threshold values to support its use

  the study aims to ascertain the robustness of d-dimer testing for PE compared to CTPA and identify the threshold values to support its use

  26 MONTHS

Study Arms (2)

D-Dimer group

A blood sample was taken before starting the patients on any thrombolytic treatment. The latex agglutination test was used to measure plasma D-dimer level; this was done using a Sysmex CA-7000 automatic coagulation unit. The positivity threshold was above 250 ng/ml.

Diagnostic Test: D-Dimer vs CTPA

CTPA group

CTPA was performed after performing blood sampling using Siemens Somatom definition AS 24 slice scanners. Non-ionic water-soluble contrast Omnipaque 350 mg I/mg or Visipaque 320 mg I/mg was injected at 4 mm/s maximum dose 100 ml using a Medtron pressure injector.

Diagnostic Test: D-Dimer vs CTPA

Interventions

D-Dimer vs CTPA DIAGNOSTIC_TEST

CTPA was performed after performing blood sampling using Siemens Somatom definition AS 24 slice scanners. Non-ionic water-soluble contrast Omnipaque 350 mg I/mg or Visipaque 320 mg I/mg was injected at 4 mm/s maximum dose 100 ml using a Medtron pressure injector.OR, A blood sample was taken before starting the patients on any thrombolytic treatment. The latex agglutination test was used to measure plasma D-dimer level; this was done using a Sysmex CA-7000 automatic coagulation unit. The positivity threshold was above 250 ng/ml.

CTPA group; D-Dimer group

Eligibility Criteria

• Age: 22 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

28 patients included, 14 patients female and 14 patients of male gender with an average age of 55.4 ±11.2 years. Presenting symptoms were mainly dyspnea, chest pain or, cough, and shortness of breath. Twenty-four patients of the total number of cases were positive for CTPA while four patients were negative for PE by CTPA. No allergy to the contrast was recorded during our study.

Sponsors & Collaborators

• Zulekha Hospitals: lead

Study Sites (1)

Zulekha Hospitals

Dubai, 457, United Arab Emirates

Location

MeSH Terms

Conditions

Embolism; Cataract, posterior polar, 1

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• helena elizabith, consultant

  Zulekha Hospitals

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 17, 2023
• Study Start: December 14, 2020
• Primary Completion: January 22, 2023
• Study Completion: January 28, 2023
• Last Updated: May 17, 2023

Record last verified: 2023-05

Locations

AE (1)