Prognostic Tools in Patients With Acute Pulmonary Thromboembolism.

• Conditions: Pulmonary Embolism

• Registration Number: NCT04237974
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study First Submitted: 2020-01-09
• Study First Submitted QC: 2020-01-19
• Study First Posted: 2020-01-23
• Study Start: 2021-04-20
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-31
• Last Update Posted: 2022-04-01
• Primary Completion: 2023-04
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
prognostic importance of lymphocyte cell count	2 years	-lymphocyte cell count (number/cubic milliliter)
prognostic importance of a D-dimer level	2 years	- D-dimer level (microgram/liter)
prognostic importance of platelet cell count	2 years	-platelet cell count (number/cubic milliliter)
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 red cell distribution width	2 years	-red cell distribution width (%)
prognostic importance of computed tomography pulmonary artery obstruction index (CT-PAOI)	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%).
prognostic importance of White blood cell count(WBC) .	2 years	* white blood cell count (number/cubic milliliter)
prognostic importance of Troponin level	2 years	-Troponin level (nanogram/milliliter)
prognostic importance of polymorphonuclear cell count	2 years	-polymorphonuclear cell count (number/cubic milliliter)
prognostic importance of C-reactive protein	2 years	- C-reactive protein (milligram /liter)
prognostic importance of hemoglobin level	2 years	-hemoglobin level (gram/deciliter)

Trial Locations

Locations (1)

Assiut university hospital; 🇪🇬 Assiut, Egypt