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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
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1922 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

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Arm Intervention/treatment
No Intervention: Control
Emergency physician will assess low risk patients for PE with conventional strategy, using D-Dimer testing with subsequent CTPA if positive
Intervention
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




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

Secondary Outcome Measures :
  1. 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

  2. Length of stay in the Emergency Department [ Time Frame: From date of entry in the emergency department to date of exit ]
  3. Anticoagulation therapy administration (number of day with treatment within three months) [ Time Frame: 3 months ]
  4. Rate of patients admitted in the hospital following Emergency Department visit [ Time Frame: 3 months ]
  5. All causes re hospitalization at 3 months [ Time Frame: 3 months ]
  6. Death from all causes at 3 months [ Time Frame: 3 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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France
Hospital Pitié-Salpêtrière
Paris, France
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Yonathan Freund Assistance Publique - Hôpitaux de Paris
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02375919    
Other Study ID Numbers: IDRCB 2015-A00215-44
P1409 ( Other Identifier: AP-HP )
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: July 25, 2017
Last Verified: June 2017
Keywords provided by Assistance Publique - Hôpitaux de Paris:
PERC rule
emergency department
pulmonary embolism
Additional relevant MeSH terms:
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Pulmonary Embolism
Embolism
Emergencies
Disease Attributes
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases