Repeated Examinations for Typing Pulmonary Embolism (RE-TyPE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 3
- 主要终点
- Clinical deterioration
研究概览
简要总结
PURPOSE
The two related purposes of the RE-TyPE study are:
- To improve understanding of the early clinical course of intermediate-high risk pulmonary embolism and its association with outcome and
- To establish a platform for longitudinal follow-up for all pulmonary embolism at Sahlgrenska University Hospital
HYPOTHESES
- 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
- Establishment of a platform for longitudinal follow-up will improve quality of care and outcome for patients with pulmonary embolism at Sahlgrenska University Hospital
详细描述
BACKGROUND
Pulmonary embolism (PE) is the third most common acute cardiovascular condition and remains associated with substantial morbidity and mortality. Although advances in therapy have reduced overall mortality, optimal treatment within the intermediate-high risk group remains uncertain. In parallel, knowledge of long-term outcomes after PE in Sweden is incomplete, largely due to the absence of a dedicated national PE registry.
Risk stratification of PE has evolved into the current four-tier European Society of Cardiology (ESC) classification, supported by clinical risk scores such as the Pulmonary Embolism Severity Index (PESI). The intermediate-high risk group is especially challenging due to marked heterogeneity in clinical course, ranging from rapid recovery to sudden deterioration. Existing risk scores were mainly developed to identify low risk patients and provide limited guidance on predicting deterioration, largely due to low positive predictive value.
Current risk stratification relies on static, single-timepoint variables, despite PE being a dynamic disease. Prospective studies evaluating the early temporal course of PE are scarce and typically focus on isolated parameters, with no studies integrating repeated clinical, imaging, and biomarker assessments.
The RE-TyPE study aims to address these gaps by characterizing the early clinical course of intermediate-high risk PE and linking this to short- and medium-term outcomes. The study will also provide a platform for long-term follow-up, evaluation of treatment strategies, and a research infrastructure dedicated to all PE at Sahlgrenska University Hospital.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥ 18 years old) who is diagnosed with, or followed as out-patients for, PE at Sahlgrenska University Hospital
- •Written informed consent
排除标准
- •from Cohort A:
- •Low risk, intermediate-low risk or high risk PE*
- •>48 hours since arrival to hospital
- •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
研究组 & 干预措施
Cohort A
Intermediate-high risk pulmonary embolism - prospective phenotyping thorugh serial investigations day 0, 1, 2 30 and 90.
Cohort B
All risk classes of pulmonary embolism - retrospective and prospective phenotyping at day 0, 90 (inclusion) and >12 months (Cohorts overlap since all patients in Cohort A are also part of Cohort B)
结局指标
主要结局
Clinical deterioration
时间窗: 7 days
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
时间窗: 7 days
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.
次要结局
- Admission rate for low risk PE(365 days)
- The composite of death, VTE recurrence or major bleeding(30 days)
- The composite of death, VTE recurrence or major bleeding(90 days)
- Chronic ThromboEmbolic Pulmonary Hypertension (CTEPH)(180 days)
- Patient reported outcome measures (PROMs)(90 days)
- Outcome for low risk PE(365 days)
- Clinically relevant non-major bleeding (CRNMB)(365 days)
研究者
Rickard Zeijlon
Consultant in Internal Medicine, Clinical Postdoctoral Researcher and Principal Investigator
Sahlgrenska University Hospital