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Trial · NCT05167734

Registered outcomes17

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

ListOutcomeTime frameDescription
PrimaryHemoglobin Concentrations1 month post-hospitalizationHemoglobin is a protein that cares oxygen through the body
SecondaryHemoglobin ConcentrationsHospital discharge (approximately 1 month), 3 months post-hospitalizationHemoglobin is a protein that cares oxygen through the body
SecondaryPhlebotomy Practice-Blood DrawsHospital discharge (approximately 1 month)Number of times subjects have blood drawn
SecondaryPhlebotomy Practice-VolumeHospital discharge (approximately 1 month)Total volume of phlebotomy blood draws
SecondaryPatient-Reported Quality of Life Measured by EuroQol (EQ-5D)Hospital discharge (approximately 1 month), 1 month post-hospitalization, 3 months post-hospitalization
The EuroQol (EQ-5D) is a 5-item questionnaire that assess health-related quality of life over five different dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Total score ranges from 0 to 100, with higher scores indicating improved health.
SecondaryAnemia-related Fatigue Measured by Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue ScaleHospital discharge (approximately 1 month), 1 month post-hospitalization, 3 months post-hospitalization
The Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale is a 13-item questionnaire used to measure the severity of fatigue and its impact on daily activities. Each question is rated on a 4-point scale where 0 represents "very much" fatigued and 4 represents "not at all" fatigued. Total scores range from 0 to 52 with lower scores indicating greater fatigue.
Secondary6 Minute Walk Distance1 and 3-months post-hospitalizationDistance walked in 6 minutes used to assess physical function after critical illness.
SecondaryCognitive Function After Critical Illness Assessed Using Montreal Cognitive Assessment (MoCA-BLIND)1 and 3-months post-hospitalization
The Montreal Cognitive Assessment (MoCA-BLIND) score assesses cognitive impairment by a 30-item questionnaire that includes tests of orientation, attention, memory, language and visual-spatial skills. Possible scores range from 0 to 30, with higher scores indicating higher cognitive function. A final total score of 26 and above is considered normal.
SecondaryMental Health - Anxiety and Depression Measured Using the Hosptial Anxiety and Depression Scale (HADS)1 and 3-months post-hospitalization
The Hospital Anxiety and Depression Scale (HADS) assesses a patient's anxiety and depression levels. Subject's answer 14 questions (7 for anxiety and 7 for depression). Each question is scored from 0-3. Total scores can range from 0 to 21 for either anxiety or depression, with higher scores indicating a presence of anxiety or depression.
SecondaryMental Health - Post-Traumatic Distress Using Impact of Events Scale-Revised (IES-R)1 and 3-months post-hospitalization
The Impact of Events Scale-Revised (IES-R) is a self-reported questionnaire that measures the distress caused by traumatic events. Subjects respond to 22 questions using a 5-point scale ranging from 0 (not at all) to 4 (extremely). Total scores range from 0 to 88, with a higher score indicting the likely presence of post-traumatic stress disorder (PTSD).
SecondaryNumber of Participants With Allogeneic Red Blood Cell Transfusions3-months post-hospitalizationNumber (percentage) of patients transfused with allogeneic red blood cells
SecondaryNumber of Transfused Units of Allogeneic Red Blood Cells3 months post hospitalizationNumber of transfused units from hospital discharge through 3-months post-hospitalization
SecondaryUnplanned Hospital Readmissions3 months and 12-months post-hospitalizationNumber of subjects to experience an unplanned hospital readmission
SecondaryMortality3 months and 12-months post-hospitalizationMortality from any cause
SecondaryAdverse Events Post-enrollmentHospital discharge (approximately 1 month), 3-months post-hospitalizationVenous thromboembolism, bloodstream infection, myocardial infarction, stroke
SecondaryAccelerometry-measured Number of Steps Taken Per Day1 and 3-months post-hospitalizationHome-based activity monitor daily step counts (optional, exploratory study component)
SecondaryAccelerometry-measured Daily Maximum Step Cadence1 month and 3 month post hospitalizationActigraphy evaluated daily Max Step Cadence - i.e., steps per minute (optional, exploratory study endpoint)

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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