Trial · NCT07603700
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | All-Cause Mortality at 30 Days | 30 days | The percentage of participants who die from any cause within 30 days of enrollment. |
| Primary | All-Cause Mortality at 90 Days | 90 days | The percentage of participants who die from any cause within 90 days of enrollment. |
| Primary | Right Ventricular to Left Ventricular (RV/LV) Ratio Improvement Rate at 48 Hours | 48 hours ± 6 hours | The proportion of participants with a reduction in RV/LV ratio ≥15% from baseline measured by CTPA or Echocardiography. |
| Secondary | Major Bleeding Events | 48 hours, 7 days, 30 days, 90 days | Incidence of major bleeding defined by ISTH, GUSTO, or BARC criteria (including intracranial hemorrhage). |
| Secondary | Clinical Deterioration | 48 hours, 7 days | Composite of hemodynamic instability, need for rescue therapy (escalation to thrombolysis/MT/ECMO), intubation, or PE-related death. |
| Secondary | 6-Minute Walk Test (6MWT) Distance | 30 days, 90 days | Change in walking distance from baseline (estimated) to follow-up. Minimal Clinically Important Difference (MCID) ≥30 meters. |
| Secondary | Post-VTE Functional Status (PVFS) Score | 30 days, 90 days | Assessment of functional limitation due to VTE (Scale 0-5). |
| Secondary | Quality of Life (PEmb-QoL) | 90 days | The questionnaire consists of 9 questions containing 40 items, which are organized into 6 domains: Frequency of Complaints (FC): Assesses the frequency of respiratory and general symptoms (e.g., dyspnea, chest pain). Daily Activity Limitations (AL): Measures limitations in performing activities of daily living (ADL). Work-related Problems (WP): Evaluates difficulties in performing work or school duties. Social Limitations (SL): Assesses restrictions on social activities. Intensity of Complaints (IC): Measures the severity of pain and breathlessness. Emotional Complaints (EC): Captures anxiety, frustration, and fear related to the disease. |
| Secondary | Symptomatic PE Recurrence | 90 days | Confirmed recurrent PE via CTPA or V/Q scan. |
| Secondary | ICU Length of Stay | From ICU admission to ICU discharge, assessed up to 30 days | Duration of intensive care unit stay during the index hospitalization |
| Secondary | Total Hospital Length of Stay | From hospital admission to hospital discharge, assessed up to 90 days | Duration of index hospitalization from emergency department admission to hospital discharge |
| Secondary | Total Medical Costs | Through 90 days | Direct medical costs incurred during index hospitalization and within 90 days of enrollment, including medications, procedures, and hospitalization |
| Other | Biomarker Improvement (Troponin, BNP, D-Dimer) | 48 hours, 7 days | Percentage reduction in cardiac biomarkers and D-Dimer levels. |
| Other | Daily Step Count | Continuous monitoring through 90 days | Average daily step count measured by smart band (e.g., Xiaomi/Huawei/Apple Watch) during the 90-day follow-up period. Assessed as a continuous variable (steps/day) and correlated with 6-Minute Walk Test distance and Post-VTE Functional Status score. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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