Emergency Patients Clinical Trial
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
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.
The diagnosis of Pulmonary Embolism (PE) in the Emergency Department (ED) is crucial. As
emergency physicians fear to miss this potential lethal condition, PE tends to be
overdiagnosed with potential source of unnecessary risks and no clear benefit in terms of
outcome. PERC is an 8-item block of clinical criteria that can identify patients who can
safely be discharged without further investigation in the ED for the diagnosis of PE. The
endorsement of this rule could markedly reduce the number of irradiative imaging studies,
length of stay in the ED, and rate of adverse event resulting from both diagnostic and
therapeutic means. Several retrospective and prospective studies have shown the safety and
benefits of PERC rule for PE diagnosis in low risk patients. However, no randomized study has
yet compared the benefit/risk ratio of PERC based strategy with the standard diagnosis
strategy and thus validated its endorsement in this setting. We hypothesize that in patients
with a low gestalt clinical probability and a PERC negative, PE can be safely ruled out and
the patient discharged with no further testing
This is a controlled, cluster randomized trial in Europe (N=15). Each center will be
randomized on the sequence of period intervention: 6 months intervention (PERC based
strategy) followed by 6 months control (usual care), or 6 months control followed by 6 months
intervention with 2 months of "wash-out" between the two periods.
The primary objective of this study is to assess the non inferiority of a PERC based
diagnosis strategy for PE low risk emergency patients, compared to the standard strategy of
D-dimer testing, on the occurrence of non-diagnosed thrombo-embolic event.
The primary outcome is the failure percentage of the diagnostic strategy, defined as
diagnosed DVT or PE at 3 month follow up, among patients for whom PE has been initially ruled
out. Exclusion of PE in the ED is made upon negative D-dimere result or negative CTPA in both
groups, or negative PERC in the intervention group.
Secondary objectives are :
To assess the reduction of unnecessary irradiative imaging studies and adverse events. To
assess the reduction in ED length of stay, undue onset of anticoagulation regimen and
associated adverse events. To assess the reduction of hospital admission, readmission, and
mortality at 3 months.
Secondary endpoints include:
- Rate of CTPA and related adverse events
- Length of stay in the ED (hours)
- Anticoagulant therapy administration and adverse events
- Admission to the hospital following ED visit.
- All causes re hospitalization at 3 months,
- Death from all causes at 3 months
The two groups will have a different work up for the diagnosis of PE in the ED as follows:
Experimental group:
PERC based strategy: work up for diagnosis of PE includes calculation of PERC. If all PERC
criteria are negative, no further testing for PE is recommended. If at least one criterion is
positive, then the patient undergoes sensitive D-dimer testing, with subsequent CTPA if
positive. In case of negative D-dimer result, PE will be excluded.
Control group:
Standard strategy: conventional work up for diagnosis of PE. Every low risk patient will
undergo sensitive D-dimer testing, with subsequent CTPA if positive. In case of negative
D-dimer, PE will be excluded.
All patients with chest pain or dyspnea will be screened and included in the ED by emergency
physicians and research assistant. If the treating emergency physician or local investigator
considers that the patient has a sufficient clinical suspicion of PE that he needs formal
work up for this diagnosis, and that this suspicion is low enough to discard this suspicion
in case of negative D-dimer, then the patient will be eligble and asked for written informed
consent.
When recruiting a patient, the emergency physician or local investigator will have to confirm
in written that he answered "yes" to the two following sentences:
This patient has a clinical suspicion of Pulmonary Embolism, and this diagnosis needs to be
formally ruled out or confirmed before discharge I estimate the empirical clinical
probability of Pulmonary Embolism as low
After written informed consent has been obtained, the patient can be included in the study.
Included patients will be followed up by phone interview or hospital visit at three months
(13 weeks) by a clinical research technician. The time frame of three months could be subject
to minor adjustement, and will occur between day 84 and day 98. Follow up visit or interview
will seek the occurrence of thrombo-embolic event (DVT documented with ultrasonography of the
lower limbs or venous CT, or PE documented with positive CTPA or high probability V/Q lung
scan), death, return visit to the ED, hospitalisation.
All medical record pertaining to the patient from this timeframe will be sought and analysed
by the local investigator, to found report of thrombo-embolic event, or adverse events from
CTPA or anticaogulation. In the cases of death, or report of a thrombo-embolic event, the
file will be analysed by a comitee of three independent experts.
This method of adjudication has been described and validated in all major previous diagnostic
studies on PE.
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