Repeated exams to classify early pulmonary embolism
Repeated Examinations for Typing Pulmonary Embolism (RE-TyPE)
This project will test whether doing repeated blood tests, ECGs, and bedside heart ultrasounds during the first 48 hours after pulmonary embolism helps predict who will get worse in adults treated at Sahlgrenska University Hospital.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sahlgrenska University Hospital Academic / other |
| Locations | 3 sites (Gothenburg, Region Västra Götaland and 2 other locations) |
| Trial ID | NCT07491094 on ClinicalTrials.gov |
What this trial studies
RE-TyPE enrolls adults with pulmonary embolism at Sahlgrenska University Hospital and performs repeated biomarker sampling, electrocardiography, and point-of-care echocardiography during the initial 48 hours for intermediate-high risk patients, while also creating a broader registry for all PE patients with follow-up around day 90. The study compares dynamic changes across these repeated measures to conventional single-timepoint variables to see if trajectories better predict short- and medium-term clinical outcomes. Cohort A focuses on intensive early monitoring of intermediate-high risk patients enrolled within 48 hours, and Cohort B establishes a platform for longitudinal follow-up of all PE patients at the center. The program is designed both to improve early risk stratification and to build an ongoing infrastructure for quality improvement and long-term outcome tracking.
Who should consider this trial
Good fit: Adults (≥18) diagnosed with pulmonary embolism at Sahlgrenska University Hospital who can give written informed consent, with priority for those classified as intermediate-high risk and enrolled within 48 hours.
Not a fit: Patients with low or intermediate-low risk PE, those presenting more than 48 hours after hospital arrival, or those unable to comply with repeated testing (for example due to cognitive impairment) are less likely to receive benefit from the intensive early monitoring component.
Why it matters
Potential benefit: If successful, this approach could improve early risk stratification and guide timelier treatment decisions, reducing unexpected deterioration and improving outcomes after pulmonary embolism.
How similar studies have performed: Prospective studies using single repeated parameters are limited and have mixed results, and an integrated repeated-measures approach like this is largely novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adult patients (≥ 18 years old) who is diagnosed with, or followed as out-patients for, PE at Sahlgrenska University Hospital 2. Written informed consent Exclusion Criteria from Cohort A: 1. Low risk, intermediate-low risk or high risk PE\* 2. \>48 hours since arrival to hospital 3. Expected inability to comply with the protocol (e.g. dementia) There are no exclusion criteria from Cohort B. Patients in Cohort B who are not part of Cohort A may be included at diagnosis (day 0) or at follow-up (\~day 90). \*If biomarkers (and/or echocardiography) are not available in hemodynamically stable patients, RV/LV-ratio \>1 will be considered as preliminary intermediate-high risk. If biomarkers later fall out negative, the patient will be considered as intermediate-low risk and will be moved to Cohort B
Where this trial is running
Gothenburg, Region Västra Götaland and 2 other locations
- Sahlgrenska University Hospital/Mölndal — Gothenburg, Region Västra Götaland, Sweden (Not_yet_recruiting)
- Sahlgrenska University Hospital/Sahlgrenska — Gothenburg, Region Västra Götaland, Sweden (Recruiting)
- Sahlgrenska University Hospital/Östra — Gothenburg, Region Västra Götaland, Sweden (Not_yet_recruiting)
Study contacts
- Study coordinator: Rickard Zeijlon, MD, PhD
- Email: rickard.zeijlon@vgregion.se
- Phone: +46313428884
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.