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Suspected Pulmonary Embolism Exclusion with D-dimers in Emergency Departments

Suspected Pulmonary Embolism Exclusion with D-dimers in Emergency Departments. Effect on 90-day incidence of Venous Thromboembolism.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12626000042347
Acronym
SPEED ED
Enrollment
1143
Registered
2026-01-12
Start date
2024-06-17
Completion date
2026-02-28
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

A new guideline was introduced in participating sites to exclude pulmonary embolism (PE) without the need for advanced imaging studies (computerised tomography pulmonary angiography or ventilation perfusion scans). This guideline involved accepting a higher threshold of a particular blood test (D-dimer) to rule out PE. Patients were contacted after 90 days post presentation to ask if they had been diagnosed with a PE or a deep vein thrombosis (which gives arise to PE).

Interventions

A new hospital approved Emergency Department PE diagnostic guideline was introduced in January 2024. Relevant guideline elements were to accept that a PE was excluded if 1. Low probability for PE (Wells score 0 to 4), and D-dimer less than 1.0 mg/L 2. Intermediate probability for PE (Wells score 4.5 to 6) and D-dimer less than aged-adjusted D-dimer threshold (age adjusted is age/100 if age over 50 [in mg/L]) Data collected during ED presentation included age, gender, clinical assessment,

A new hospital approved Emergency Department PE diagnostic guideline was introduced in January 2024. Relevant guideline elements were to accept that a PE was excluded if 1. Low probability for PE (Wells score 0 to 4), and D-dimer less than 1.0 mg/L 2. Intermediate probability for PE (Wells score 4.5 to 6) and D-dimer less than aged-adjusted D-dimer threshold (age adjusted is age/100 if age over 50 [in mg/L]) Data collected during ED presentation included age, gender, clinical assessment, Wells score, D-dimer result, imaging study result, reason for deviation from guideline and ED length of stay. Data collected from case report forms and from the electronic medical record. Study duration from June 2024 to February 2026. Patients eligible for follow up contacted after 90 days post ED presentation. Information collected was if a diagnosis had been made of DVT or PE. If there was a diagnosis made, the date of diagnosis was then requested.

Sponsors

Townsville Hospital and Health Service
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients aged 18 years and above where PE is considered a potential diagnosis AND 2(a). Assessed by a senior emergency clinician (trainee or specialist) as having a low clinical pre-test probability of pulmonary embolism (as defined by a Wells’ score of 4 or less and unable to be excluded from further testing based on Pulmonary Embolism Rule out Criteria) and serum D-dimer 0.5mg/L – 0.99mg/L OR 2(b). Assessed by a senior emergency clinician (trainee or specialist) as having an intermediate clinical pre-test probability of pulmonary embolism (as defined by Wells' score of 4.5-6) and serum D-dimer < age adjusted threshold

Exclusion criteria

Received a CTPA or VQ scan during the presentation while under the care of the Emergency Department Known pregnancy On anticoagulation Inability to follow-up at 90 days after the index ED presentation Correction service inmates Previous enrolment in SPEED-ED Consent Withdrawn

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026