Short-term Clinical Deterioration After Acute Pulmonary Embolism

Pulmonary Embolism Clinical Trial

Official title:

Short-term Clinical Deterioration After Acute Pulmonary Embolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03915925
• Other study ID #: 1R01HS025979
• Status: Completed
• Start date: September 30, 2018
• Est. completion date: November 30, 2020

Study information

• Verified date: July 2019
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective, observational, multicenter cohort study to compare right ventricular dysfunction dependent and independent prognostic models for short-term serous adverse events in patients who are diagnosed with pulmonary embolism in the emergency department. Clinical endpoints are assessed at days 1-5. A thirty-day follow-up phone call is conducted to obtain further clinical endpoints and a quality of life assessment.

Description:

The objective of this study is to compare right ventricular dysfunction (RVD)dependent and independent prognostic models for short-term serious adverse events in pulmonary embolism (PE) patients. The target population is emergency department (ED) patients with confirmed acute PE within 12 hours of ED presentation. The primary outcome is a composite of death, delayed circulatory or respiratory dysfunction, hypoxia, and reperfusion intervention within five days of PE diagnosis. Secondary outcomes will be nonfatal bleeding, recurrence of venous thromboembolism, and hypoxia requiring oxygen supplementation. The specific aims are: 1) determine the incidence of death, circulatory and respiratory deterioration, and administration of reperfusion therapy within five days of PE; 2) determine functional outcomes 30 days after PE using the Pulmonary Embolism Quality of Life Questionnaire; 3) evaluate the sensitivity, specificity, and positive and negative likelihood ratios of each RVD assessment tool for clinical deterioration within five days of PE; and 4) derive a prediction model for clinical deterioration within five days of PE diagnosis. Patients with confirmed PE will be assessed for hemodynamic stability at presentation, and then will be assessed for RVD. Normotensive PE patients without RVD will be assessed by a clinically derived model (sPESI or HESTIA) to determine if they are low risk or intermediate-low risk. The investigators will then determine incidence of the clinical endpoints during the subsequent 5 days, as well as 30 days later. The 30-day follow-up will also include administration of the validated Pulmonary Embolism Quality of Life questionnaire (PEmbQoL).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 935
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men and women, 18 years or older, with image confirmed acute pulmonary embolism diagnosed within 12 hours of ED presentation

Exclusion Criteria:

• Patients who decline any participation in the study
• Patients 17 years old and younger at the time of screening
• Radiologist's over read that determines that filling defects identified as acute emboli are instead either chronic, resolving, or unchanged after comparison to previous CT, if available
• If empiric anticoagulation or escalated intervention were initiated more than 12 hours before presentation to the recruiting ED
• Identification of either segmental or subsegmental intraluminal filling defects on CT that are considered to be clinically incidental and unrelated to primary diagnostic workup or ED presentation.

Related Conditions & MeSH terms

• Clinical Deterioration
• Embolism
• Pulmonary Embolism

Locations

Country	Name	City	State
United States	Carolinas Medical Center - Main	Charlotte	North Carolina
United States	Vanderbilt Medical Center	Nashville	Tennessee
United States	Christiana Care Health System	Newark	Delaware
United States	Orlando Regional Medical Center	Orlando	Florida
United States	Univeristy of Utah Hospital	Salt Lake City	Utah
United States	San Diego Medical Center	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Development of prediction model for clinical deterioration outcomes within 5 days of PE presentation to emergency department	Use of logistic regression analysis to determine predictors of clinical deteriortion a=within 5 days of acute PE presentation at emergency department	5 days
Primary	Compare the risk ratio odds ratio of different PE risk stratification models for clinical Deterioration	Provide and compare the number and proportion of patients with both composite and individual outcome of death, circulatory deterioration, respiratory deterioration, administration of reperfusion therapy	Five days from diagnosis
Secondary	Compare the prognostic accuracy of different right ventricular dysfunction parameters for predefined clinical deterioration outcomes within 5 days	Comparison of different Right Ventricular Dysfunction Assessments for Clinical deterioration within 5 days of PE diagnosis	5 days from diagnosis
Secondary	Comparison of Patient Reported Pulmonary Embolism Functional outcomes at 30 days after Pulmonary Embolism Diagnosis	Comparison of functional outcomes between patients with and without Right ventricular dysfunction at presentation with higher scores indicating worse outcomes THe Pulmonary Embolism Quality of Life Questionnaire has six dimension of questions. Dimension scores are transformed into to scale from 0-100 with higher scores associated with worse outcomes.	30 days after PE diagnosis