Prognostic Tools in Patients With Acute Pulmonary Thromboembolism.

March 31, 2022 updated by: Amal Abdallah Abd Elrahman, Assiut University

Evaluation of Different Prognostic Tools in Patients With Acute Pulmonary Thromboembolism

Acute pulmonary embolism (PE) is a serious disease associated with high mortality rates despite advanced therapeutic options. The treatment options depend on the severity of the disease and the short - term mortality varies widely from 2 to 95%, depending on the severity of the condition

Study Overview

Status

Recruiting

Conditions

Detailed Description

Acute pulmonary embolism (PE) is a serious disease associated with high mortality rates despite advanced therapeutic options. The treatment options depend on the severity of the disease and the short - term mortality varies widely from 2 to 95%, depending on the severity of the condition.

Initial risk stratification of patients with PE could be based on clinical indicators. The presence of shock and hypotension is the most important clinical sign of poor prognosis. Other clinical variables, associated with poor prognosis are age over 70 years, history of bed rest over five days, cancer, chronic obstructive pulmonary disease, renal failure, heart failure, and tachycardia .

Echocardiography represents the most useful imaging tool in everyday clinical practice to show right ventricular dysfunction (RVD) because of its noninvasive nature and relative low cost. RVD assessed on echocardiography has been described as one of the strongest predictor of early mortality in PE .

Currently, computed tomography pulmonary angiography (CTPA) represents the diagnostic gold standard for PE. Additionally, CTPA was used to evaluate the prognosis by determining the distribution and severity of vascular obstruction of clots in pulmonary circulation; this is called computed tomography pulmonary artery obstruction index (CT-PAOI). CTPA was also suggested as a predictor of RVD .

In addition to the clinical findings and the imaging abnormalities, there are several biomarkers and indicators that can be used to predict severity and prognosis in patients with PE. These biomarkers include troponin and brain natriuretic peptide (indicators of RVD and myocardial damage), D-dimer, C-reactive protein, arterial blood gases parameters and complete blood count (CBC) parameters. However, some of these biomarkers have not been widely studied and are not commonly used although they are readily available and cheaper for developing countries.

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

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

Study Contact

Study Locations

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

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients admitted at the Chest Department and Respiratory Intensive Care Unit (RICU) at Assiut University Hospital.

Description

Inclusion Criteria:

  • Adults (≥ 18 years) who will be diagnosed as acute pulmonary embolism based on computed tomography pulmonary angiography (CTPA) and not yet treated.

Exclusion Criteria:

  1. Age less than 18 years.
  2. Patients with known hematological disorders.
  3. Patients with history of recent blood transfusion (within 3 weeks).
  4. Patients receive anti-platelet and/or anticoagulant medications.
  5. Patients receive immunosuppressive drugs.
  6. Patients with known cardiopulmonary diseases other than the pulmonary embolism.
  7. Patients with known active infectious diseases or immunological diseases

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prognostic importance of computed tomography pulmonary artery obstruction index (CT-PAOI)
Time Frame: 2 years
To calculate the CT-PAOI, the arterial tree of each lung was considered to have 10 segmental arteries . The presence of an embolus in a segmental artery was scored 1 point. Central or paracentral emboli were scored a value equal to the number of segmental arteries arising distally. Depending on the degree of vascular obstruction a weighting factor was assigned to each value (0, no thrombus 1, partial occlusion and 2, total occlusion). Isolated subsegmental embolus was considered as a partially occluded segmental artery and was assigned a value of1. Thus, the PAOI could vary from 1 to 40 points per patient. Dividing the patient score by the maximal total score and multiplying the result by 100 calculated the percentage of vascular obstruction, Based on the which, patients were then divided into three groups (<15% versus 15-50% versus >50%).
2 years
prognostic importance of White blood cell count(WBC) .
Time Frame: 2 years
  • white blood cell count (number/cubic milliliter)
2 years
prognostic importance of polymorphonuclear cell count
Time Frame: 2 years
-polymorphonuclear cell count (number/cubic milliliter)
2 years
prognostic importance of lymphocyte cell count
Time Frame: 2 years
-lymphocyte cell count (number/cubic milliliter)
2 years
prognostic importance of a D-dimer level
Time Frame: 2 years
- D-dimer level (microgram/liter)
2 years
prognostic importance of Troponin level
Time Frame: 2 years
-Troponin level (nanogram/milliliter)
2 years
prognostic importance of C-reactive protein
Time Frame: 2 years
- C-reactive protein (milligram /liter)
2 years
prognostic importance of arterial blood gases while the patients are breathing room air.
Time Frame: 2 years
-Partial pressure of oxygen tension (millimeter mercury)
2 years
prognostic importance of hemoglobin level
Time Frame: 2 years
-hemoglobin level (gram/deciliter)
2 years
prognostic importance of platelet cell count
Time Frame: 2 years
-platelet cell count (number/cubic milliliter)
2 years
prognostic importance of red cell distribution width
Time Frame: 2 years
-red cell distribution width (%)
2 years

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Yousef A Yousef, Professor, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 20, 2021

Primary Completion (ANTICIPATED)

April 1, 2023

Study Completion (ANTICIPATED)

October 1, 2023

Study Registration Dates

First Submitted

January 9, 2020

First Submitted That Met QC Criteria

January 19, 2020

First Posted (ACTUAL)

January 23, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 1, 2022

Last Update Submitted That Met QC Criteria

March 31, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

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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