PERC Rule to Exclude Pulmonary Embolism in the Emergency Deparment

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02375919
• Date of registration: 24/02/2015
• Prospective Registration: Yes
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: PERC Rule to Exclude Pulmonary Embolism in the Emergency Deparment PROPER
• Scientific title: The Pulmonary Embolism Rule Out Criteria (PERC) Rule to Exclude the Diagnosis of Pulmonary Embolism in Emergency Low Risk Patients: a Non-inferiority Randomized Controlled Trial
• Date of first enrolment: August 2015
• Target sample size: 1922
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02375919
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Yonathan Freund
• Affiliation: Assistance Publique - Hôpitaux de Paris

Key inclusion & exclusion criteria

Inclusion Criteria:

- Acute onset of, or worsening of dyspnea Or chest pain

- Low clinical pretest probability of PE, empiricially estimated by the gestalt.

Exclusion Criteria:

- Other obvious cause than PE for dyspnea or chest pain

- Acute severe presentation

- Contra-indication to CTPA

- Concurrent anticoagulation treatment

- Current diagnosed thrombo-embolic event

- Inability to follow up

- Prisoners

- Pregnancy

- No social security

- Participation in another intervention trial



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Emergency Patients

Intervention(s)

Other: PERC based Strategy

Primary Outcome(s)

Failure percentage of the diagnostic strategy (diagnosed deep venous thrombosis or pulmonary embolism) at 3 month follow up [Time Frame: 3 months]

Secondary Outcome(s)

All causes re hospitalization at 3 months [Time Frame: 3 months]

Anticoagulation therapy administration (number of day with treatment within three months) [Time Frame: 3 months]

Rate of Computed Tomography Pulmonary Angiogram (CTPA) and related adverse event [Time Frame: 3 months]

Length of stay in the Emergency Department [Time Frame: From date of entry in the emergency department to date of exit]

Rate of patients admitted in the hospital following Emergency Department visit [Time Frame: 3 months]

Death from all causes at 3 months [Time Frame: 3 months]

Secondary ID(s)

P1409

IDRCB 2015-A00215-44

Source(s) of Monetary Support

Please refer to primary and secondary sponsors