Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06190392
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-05
First Post:
2023-12-19
Brief Title:
Effect of a Global Simplified Strategy on Thromboembolic Events in Emergency Department Patients With Suspected Pulmonary Embolism
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Effect of a Global Simplified Strategy on Thromboembolic Events in Emergency Department Patients With Suspected Pulmonary Embolism
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MODS STRATEGY
Brief Summary:
Pulmonary embolism PE is frequently suspected in emergency departments ED patients which often leads to the prescription of DDimer testing and irradiative chest imaging Computed Tomographic Pulmonary Angiogram CTPA in most cases1 Indeed an increased use of CTPA has been reported without clear benefit in terms of prognosisThis increased use is reportedly associated with potential overdiagnosis of PE increased cost length of ED stay and side effects from both chest imaging and undue anticoagulant treatments The standard diagnostic strategy for PE work up includes three steps with an initial evaluation of clinical probability followed by D-dimer testing if indicated followed by chest imaging if necessary - Computed tomographic pulmonary angiogram CTPA being the imaging modality of choice
A large European prospective study has reported that the use of CTPA has constantly increased without change in the diagnostic yield In order to reduce the use of CTPA it has been validated that in patients with a low likelihood of PE the D-dimer threshold for ordering CTPA can be raised at 1000 ngml It has been validated that a low likelihood of PE can be determined either with the YEARS or the PEGeD clinical decision rules These latter two include one common item being Is PE the most likely diagnosis A retrospective cohort study of 3330 patients reported that using this sole question of Is PE the most likely diagnosis can be safely used to raise the D-dimer threshold to 1000 ngml and that this performs as well as YEARS and PEGeD This simple question is easier to use by emergency physicians compared to complex ones which are reportedly seldom used by emergency physicians Therefore the validation of the PE unlikely simple and straightforward decision rule could increase physicians adherence and therefore limit the use of chest imaging
The hypothesis of this prospective study is that the likelihood of PE assessed to elevate the DDimer threshold to 1000 ngml can be estimated by the sole question of is PE the most likely diagnosis and to validate a global simplified diagnostic strategy for PE in the ED
The intervention will be the patients management with a simplified global strategy Whether PE is the most likely diagnostic will be assessed by the unstructured implicit clinicians estimation
In patient with a clinical suspicion of pulmonary embolism DDimer testing will be performed
If the likelihood of PE is low PE is not the most likely diagnosis then threshold for DDimer testing will be 1000 ngml If the likelihood of PE is high PE is the most likely diagnosis then the age-adjusted DDimer threshold will be applied
A large European prospective study has reported that the use of CTPA has constantly increased without change in the diagnostic yield In order to reduce the use of CTPA it has been validated that in patients with a low likelihood of PE the D-dimer threshold for ordering CTPA can be raised at 1000 ngml It has been validated that a low likelihood of PE can be determined either with the YEARS or the PEGeD clinical decision rules These latter two include one common item being Is PE the most likely diagnosis A retrospective cohort study of 3330 patients reported that using this sole question of Is PE the most likely diagnosis can be safely used to raise the D-dimer threshold to 1000 ngml and that this performs as well as YEARS and PEGeD This simple question is easier to use by emergency physicians compared to complex ones which are reportedly seldom used by emergency physicians Therefore the validation of the PE unlikely simple and straightforward decision rule could increase physicians adherence and therefore limit the use of chest imaging
The hypothesis of this prospective study is that the likelihood of PE assessed to elevate the DDimer threshold to 1000 ngml can be estimated by the sole question of is PE the most likely diagnosis and to validate a global simplified diagnostic strategy for PE in the ED
The intervention will be the patients management with a simplified global strategy Whether PE is the most likely diagnostic will be assessed by the unstructured implicit clinicians estimation
In patient with a clinical suspicion of pulmonary embolism DDimer testing will be performed
If the likelihood of PE is low PE is not the most likely diagnosis then threshold for DDimer testing will be 1000 ngml If the likelihood of PE is high PE is the most likely diagnosis then the age-adjusted DDimer threshold will be applied
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-A01956-39 | OTHER | IDRCB ANSM | None |