PURPOSE
The two related purposes of the RE-TyPE study are:
1. To improve understanding of the early clinical course of intermediate-high risk pulmonary embolism and its association with outcome and 2. To establish a platform for longitudinal follow-up for all pulmonary embolism at Sahlgrenska University Hospital
HYPOTHESES
1. The dynamic pattern of change, evaluated thorough repeated measures of biomarkers, electrocardiography and echocardiography during the first 48 hours after pulmonary embolism, better predicts outcome than static measurements currently used to predict outcome 2. Establishment of a platform for longitudinal follow-up will improve quality of care and outcome for patients with pulmonary embolism at Sahlgrenska University Hospital
Adult patients (≥ 18 years old) who is diagnosed with, or followed as out-patients for, PE at Sahlgrenska University Hospital
Written informed consent
Low risk, intermediate-low risk or high risk PE*
>48 hours since PE diagnosis
Expected inability to comply with the protocol (e.g. dementia)
Adult patients diagnosed with pulmonary embolism during routine clinical care at Sahlgrenska University Hospital in Gothenburg. Patients are identified through hospital services responsible for the diagnosis and management of pulmonary embolism within the regional healthcare system of Region Västra Götaland (Sweden).
Cohort
Prospective
Not listed
Clinical deterioration
The composite of: All-cause death, cardiac arrest, hemodynamic decompensation (systolic blood pressure \<90 mmHg, need of vasopressor, clinical signs of hypoperfusion or fall of systolic blood pressure \>40 mmHg in 15 minutes), respiratory failure (need of respiratory support such as high-flow nasal oxygen, non-invasive ventilation or intubation), escalation to rescue reperfusion therapy (thrombolysis, thrombectomy/FlowTriever, surgery), National Early Warning Score 2 (NEWS2) -score ≥7 or transfer to intensive care unit ("IVA" as defined at Sahlgrenska) due to PE. Each individual outcome will also be analysed independently.
Major bleeding
According to ISTH (International Society on Thrombosis and Haemostasis) as fatal bleeding, and/or symptomatic bleeding in a critical area or organ (such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial), or intramuscular with compartment syndrome, and/or bleeding causing a fall in hemoglobin levels of 20 g/L or greater, or leading to a transfusion of 2 units or more of whole blood or red cells.
Death, VTE recurrence or major bleeding
Death (all-cause), recurrent VTE or major bleeding (according to ISTH)
Death, VTE recurrence or major bleeding
Death (all-cause), recurrent VTE or major bleeding (according to ISTH)
Death, VTE recurrence or major bleeding
Death (all-cause), recurrent VTE or major bleeding (according to ISTH)
Chronic ThromboEmbolic Pulmonary Hypertension (CTEPH)
Patient medical chart CTEPH diagnosis at long-term follow up
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Sahlgrenska University Hospital
Lead sponsor
Gothia Forum - Center for Clinical Trial
Collaborator
