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Prognostic Tools in Patients With Acute Pulmonary Thromboembolism.

Evaluation of Different Prognostic Tools in Patients With Acute Pulmonary Thromboembolism

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04237974
Enrollment
80
Registered
2020-01-23
Start date
2021-04-20
Completion date
2023-10-31
Last updated
2022-04-01

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

Conditions

Pulmonary Embolism

Brief summary

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

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.

Interventions

The radiological severity of pulmonary embolism will be assessed by using the computed tomography pulmonary arterial obstruction index (CT-PAOI)

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

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

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

Design outcomes

Primary

MeasureTime frameDescription
prognostic importance of computed tomography pulmonary artery obstruction index (CT-PAOI)2 yearsTo 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%).
prognostic importance of White blood cell count(WBC) .2 years* white blood cell count (number/cubic milliliter)
prognostic importance of polymorphonuclear cell count2 years-polymorphonuclear cell count (number/cubic milliliter)
prognostic importance of lymphocyte cell count2 years-lymphocyte cell count (number/cubic milliliter)
prognostic importance of a D-dimer level2 years\- D-dimer level (microgram/liter)
prognostic importance of Troponin level2 years-Troponin level (nanogram/milliliter)
prognostic importance of C-reactive protein2 years\- C-reactive protein (milligram /liter)
prognostic importance of arterial blood gases while the patients are breathing room air.2 years-Partial pressure of oxygen tension (millimeter mercury)
prognostic importance of hemoglobin level2 years-hemoglobin level (gram/deciliter)
prognostic importance of platelet cell count2 years-platelet cell count (number/cubic milliliter)
prognostic importance of red cell distribution width2 years-red cell distribution width (%)

Countries

Egypt

Contacts

Primary ContactAmal A Abd Elrahman, MD
amalabdallah1490@yahoo.com01067990873

Outcome results

None listed

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