PERC Rule to Exclude Pulmonary Embolism in the Emergency Deparment (PROPER)
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|ClinicalTrials.gov Identifier: NCT02375919|
Recruitment Status : Completed
First Posted : March 3, 2015
Last Update Posted : July 25, 2017
The Pulmonary Embolism Rule Out Criteria (PERC) is an 8-item rule, that was derived and tested to rule out the diagnosis of Pulmonary Embolism (PE) in the Emergency Department (ED) amongst low risk patients. Even though meta analyses have confirmed the safety of its utilization, equipoise remains - especially in European country where the prevalence of PE is higher than in the US- on whether this rule could be safely applied to all low risk emergency patients with a suspicion of PE.
The PROPER Trial is a non inferiority , cluster randomized trial. All centers will recruit patients with a suspicion of PE and a low pre test probability. To rule out the diagnosis of PE, center will use the usual diagnostic strategies with D-dimeres measurement for 6 months, and PERC based strategy for 6 months.
In the control group (usual strategy), patients will be tested for D-dimeres, followed if positive by a Computed Tomography of Pulmonary Artery (CTPA).
In the intervention group (PERC Based), patients will be first assessed with PERC score. If PERC=0, then the diagnosis of PE will be exclude with no supplemental investigations. If PERC>0, then patients will undergo the usual strategy, with D-dimeres measurement +/- CTPA.
The primary outcome is the failure percentage of the diagnostic strategy, defined as diagnosed deep venous thrombosis (DVT) or PE at 3 month follow up, among patients for whom PE has been initially ruled out.
|Condition or disease||Intervention/treatment||Phase|
|Emergency Patients||Other: PERC based Strategy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1922 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official 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|
|Actual Study Start Date :||August 2015|
|Actual Primary Completion Date :||April 2017|
|Actual Study Completion Date :||April 2017|
No Intervention: Control
Emergency physician will assess low risk patients for PE with conventional strategy, using D-Dimer testing with subsequent CTPA if positive
PERC based Strategy : Emergency physician will assess low risk patients for PE first with calculation of PERC score. If all PERC criteria are negative, then no further testing for PE is recommended. If at least one criterion is positive, then the patient undergoes D-Dimer testing with subsequent CTPA if positive
Other: PERC based Strategy
work up for diagnosis of PE includes calculation of PERC
- Failure percentage of the diagnostic strategy (diagnosed deep venous thrombosis or pulmonary embolism) at 3 month follow up [ Time Frame: 3 months ]
- Rate of Computed Tomography Pulmonary Angiogram (CTPA) and related adverse event [ Time Frame: 3 months ]Rate of CTPA related adverse events, defined as anaphylactoid reaction requiring therapeutic intervention within 24 hours, and contrast induced nephropathy with documented >25% increase in creatinine level within three months
- Length of stay in the Emergency Department [ Time Frame: From date of entry in the emergency department to date of exit ]
- Anticoagulation therapy administration (number of day with treatment within three months) [ Time Frame: 3 months ]
- Rate of patients admitted in the hospital following Emergency Department visit [ Time Frame: 3 months ]
- All causes re hospitalization at 3 months [ Time Frame: 3 months ]
- Death from all causes at 3 months [ Time Frame: 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02375919
|Principal Investigator:||Yonathan Freund||Assistance Publique - Hôpitaux de Paris|