Clinical trial NCT04327960: Risk Assessment Strategies in Pulmonary Embolism
Official title: Risk Stratification in Pulmonary Embolism
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Embolism
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-03-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The present study is a cross-sectional study. All patients consecutively admitted to Assuit University Hospital, diagnosid with PE will be included.

At least 80 patients will be included in the present study. Sample size was calculated using Epi- Info version 7, based on a previous study conducted by Yousif and Hussein (2019), which demonstrated that the mortality rate from pulmonary embolism was 13.7%, with a confidence limit of 5% and a confidence level of 80%. To overcome the dropouts the sample may be extended to 100 patients.

Brief summary: The aim of this study is to evaluate different scores of risk assessment in patients with pulmonary embolism. This study aim to compare the accuracy of these scores in predicting mortality during hospital admission.

Detailed description: Pulmonary embolism (PE) is a potentially life-threatening cardiovascular emergency with a high mortality rate.Approximately 1% of all hospitalized patients and 10% of all in-hospital mortalities are PE related. Adding to this, acute PE is linked to comparatively high (≥13%) short-term mortalities that occur either in hospital or within 30 days.

Some studies have demonstrated that PE may indicate increased 1-year mortality rates up to 25%,,. Therefore, PE is considered a potentially fatal disease, although patients who escape a PE-related death are still endangered by hematologic mishaps, especially recurrence of VTE and/or PE, or on the contrary, serious hemorrhage5.

Risk stratification of patients with acute PE is mandatory for determining the appropriate therapeutic management approach. Risk classification of PE can discriminate low-risk patients, who can be medicated as outpatients, from others at high risk, in whom a profit from intensive care unit admission or even in-hospital thrombolytic therapy is expected.

Eligibility criteria: Inclusion Criteria:

-

All patients will be subjected to the following:

1. Complete history taking and clinical examination.
2. Chest x-ray
3. ECG and echocardiography.
4. Arterial blood gases.
5. Multislice CT angiography of the chest.
6. Laboratory tests and biomarkers.

Exclusion Criteria:

* 1- Patients with unexpected or accidental diagnosis of PE (patients undergoing diagnostic tests for another suspected disease.

  2- Patients with acute left heart failure or acute respiratory failure responsible for symptoms.

  3- Patient with recurrent PE (only the first event was included in the analysis).

Primary outcomes:
measure: Pulmonary embolism-related death
timeFrame: Baseline
Secondary outcomes:
measure: hospital stay, need for ICU admission, need for mechanical ventilation or cardiopulmonary resuscitation or home dischage.
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
References:
citation: Jimenez D, Lobo JL, Fernandez-Golfin C, Portillo AK, Nieto R, Lankeit M, Konstantinides S, Prandoni P, Muriel A, Yusen RD; PROTECT investigators. Effectiveness of prognosticating pulmonary embolism using the ESC algorithm and the Bova score. Thromb Haemost. 2016 Apr;115(4):827-34. doi: 10.1160/TH15-09-0761. Epub 2016 Jan 7.
citation: Hobohm L, Hellenkamp K, Hasenfuss G, Munzel T, Konstantinides S, Lankeit M. Comparison of risk assessment strategies for not-high-risk pulmonary embolism. Eur Respir J. 2016 Apr;47(4):1170-8. doi: 10.1183/13993003.01605-2015. Epub 2016 Jan 7.