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Trial · NCT07603700

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryAll-Cause Mortality at 30 Days30 daysThe percentage of participants who die from any cause within 30 days of enrollment.
PrimaryAll-Cause Mortality at 90 Days90 daysThe percentage of participants who die from any cause within 90 days of enrollment.
PrimaryRight Ventricular to Left Ventricular (RV/LV) Ratio Improvement Rate at 48 Hours48 hours ± 6 hoursThe proportion of participants with a reduction in RV/LV ratio ≥15% from baseline measured by CTPA or Echocardiography.
SecondaryMajor Bleeding Events48 hours, 7 days, 30 days, 90 daysIncidence of major bleeding defined by ISTH, GUSTO, or BARC criteria (including intracranial hemorrhage).
SecondaryClinical Deterioration48 hours, 7 daysComposite of hemodynamic instability, need for rescue therapy (escalation to thrombolysis/MT/ECMO), intubation, or PE-related death.
Secondary6-Minute Walk Test (6MWT) Distance30 days, 90 daysChange in walking distance from baseline (estimated) to follow-up. Minimal Clinically Important Difference (MCID) ≥30 meters.
SecondaryPost-VTE Functional Status (PVFS) Score30 days, 90 daysAssessment of functional limitation due to VTE (Scale 0-5).
SecondaryQuality 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.
SecondarySymptomatic PE Recurrence90 daysConfirmed recurrent PE via CTPA or V/Q scan.
SecondaryICU Length of StayFrom ICU admission to ICU discharge, assessed up to 30 daysDuration of intensive care unit stay during the index hospitalization
SecondaryTotal Hospital Length of StayFrom hospital admission to hospital discharge, assessed up to 90 daysDuration of index hospitalization from emergency department admission to hospital discharge
SecondaryTotal Medical CostsThrough 90 daysDirect medical costs incurred during index hospitalization and within 90 days of enrollment, including medications, procedures, and hospitalization
OtherBiomarker Improvement (Troponin, BNP, D-Dimer)48 hours, 7 daysPercentage reduction in cardiac biomarkers and D-Dimer levels.
OtherDaily Step CountContinuous 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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