Effect of Fufang E'Jiao Jiang on Hierarchical Composite Clinical Benefit and Health-related Quality of Life in ICU Survivors After ICU Discharge: a Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial (LIFT)
This study aims to evaluate the effects of Fufang E'jiao Jiang on clinical outcomes, health-related quality of life, and functional recovery in survivors of critical illness following intensive care unit (ICU) discharge.This multicenter, randomized, double-blind, placebo-controlled trial will enroll 246 participants who will be randomly assigned in a 1:1 ratio to receive either Fufang E'jiao Jiang or matching placebo. Participants will receive 20 mL orally three times daily for 90 days, alongside standard post-ICU rehabilitation and supportive care.The primary outcome is a prespecified hierarchical composite endpoint assessed within 90 days after randomization and analyzed using the win ratio method. The components are evaluated in the following order of clinical priority: (1) all-cause mortality within 90 days; (2) unplanned all-cause readmission within 90 days; and (3) change from baseline in the EQ-5D-5L utility index at day 90. Secondary outcomes include exercise tolerance, frailty, cognitive function, fatigue, anxiety and depression, sleep quality assessed by wrist actigraphy and the Pittsburgh Sleep Quality Index (PSQI), appetite, handgrip strength, body composition, and selected biochemical, hematologic, and iron metabolism-related indicators. The trial aims to provide clinical evidence regarding the potential role of Fufang E'jiao Jiang in supporting recovery and improving health-related outcomes among survivors of critical illness after ICU discharge.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Post-intensive care syndrome is common among survivors of critical illness and is associated with impaired physical function, cognitive dysfunction, psychological symptoms, reduced quality of life, and increased health care utilization after intensive care unit (ICU) discharge. Current post-ICU rehabilitation strategies remain limited, and effective pharmacologic interventions are lacking. Fufang E'jiao Jiang is a traditional Chinese medicine preparation that has been used to improve fatigue, nutritional status, and functional recovery in relevant clinical settings. Based on its traditional indications and existing pharmacologic evidence, it may have potential value in supporting recovery among survivors of critical illness after ICU discharge. This study is a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial designed to evaluate the efficacy and safety of Fufang E'jiao Jiang in adult survivors of critical illness after ICU discharge. A total of 246 participants will be enrolled and randomly assigned in a 1:1 ratio to receive either Fufang E'jiao Jiang or matching placebo. Study treatment will begin after ICU discharge once enteral nutrition has been initiated. Participants in both groups will receive standard post-ICU rehabilitation and supportive care. The investigational group will receive Fufang E'jiao Jiang, 20 mL orally three times daily for 90 consecutive days. The control group will receive a matching placebo with the same dosing schedule, appearance, packaging, color, and taste but without the active ingredients of Fufang E'jiao Jiang. The primary outcome is a prespecified hierarchical composite endpoint evaluated within 90 days after randomization and analyzed using the win ratio method. The components will be compared sequentially according to their predefined clinical priority: (1) all-cause mortality within 90 days after randomization; (2) unplanned all-cause readmission within 90 days after randomization; and (3) change from baseline in the EQ-5D-5L utility index at day 90, using a prespecified clinically meaningful threshold. The primary treatment effect will be summarized using a single win ratio. Secondary outcomes will assess multiple domains of post-ICU recovery, including physical function, frailty, cognitive function, fatigue, psychological health, sleep quality, appetite, nutritional status, body composition, and selected laboratory indicators. Physical and functional assessments will include the 6-minute walk test distance, Clinical Frailty Scale score, Montreal Cognitive Assessment score, Fatigue Severity Scale score, Hospital Anxiety and Depression Scale score, and handgrip strength. Sleep-related outcomes will be assessed using both objective and subjective measurements. Objective sleep parameters, including total sleep time, sleep efficiency, and wake after sleep onset, will be recorded using a wearable sleep wristband (actigraphy). Subjective sleep quality will be evaluated using the Pittsburgh Sleep Quality Index (PSQI). Body composition will be assessed using the Nutrilab body composition analysis system. The assessed parameters will include body fat percentage, fat mass, skeletal muscle mass, and fat-free mass. Biochemical and hematologic assessments will include hemoglobin concentration, albumin, prealbumin, C-reactive protein, creatinine, blood urea nitrogen, red blood cell count, absolute lymphocyte count, and white blood cell count. Hemoglobin concentration and blood cell counts will be assessed using whole-blood hematological analysis. The percentage of HLA-DR-positive monocytes will be assessed in peripheral blood using flow cytometry. Additional hematologic and iron metabolism-related assessments will include absolute reticulocyte count, reticulocyte hemoglobin content (RET-He or CHr), serum ferritin concentration, and transferrin saturation (TSAT). TSAT will be calculated using serum iron concentration and total iron-binding capacity, with the latter measured directly or derived from transferrin concentration using a validated laboratory method. Plasma growth differentiation factor 15 (GDF15) concentration will also be assessed. Sleep quality and body composition will be evaluated at baseline, day 30, and day 90 after randomization. The selected biochemical, hematologic, and iron metabolism-related indicators will be assessed at baseline and day 90 after randomization. The trial is intended to generate clinical evidence regarding the role of Fufang E'jiao Jiang in supporting functional recovery, health-related quality of life, and selected hematologic, nutritional, and metabolic outcomes among survivors of critical illness after ICU discharge.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Liang Tan
- Telefonní číslo: +86-158-2354-0630
- E-mail: liangtan@tmmu.edu.cn
Studijní místa
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Chongqing, Čína, China
- Chongqing Iron and Steel General Hospital
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Kontakt:
- zhigao He
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Chongqing, Čína, China
- Chongqing University Affiliated Jiangjin Hospital (Chongqing Jiangjin District Central Hospital)
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Kontakt:
- jun Yang
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Chongqing, Čína, China
- Dianjiang County People's Hospital of Chongqing
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Kontakt:
- jianbin Huang
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Chongqing, Čína, China
- Hechuan Hospital of Traditional Chinese Medicine
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Kontakt:
- changyuan Zhou
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Chongqing, Čína, China
- Jiangsu Province Hospital of Chinese Medicine Chongqing Hospital (Chongqing Yongchuan District Hospital of Traditional Chinese Medicine)
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Kontakt:
- ke Li
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Chongqing, Čína, China
- No. 958 Hospital of Chinese PLA Land Force
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Kontakt:
- Xuemei Yang
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Chongqing, Čína, China
- People's Hospital of Shapingba District
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Kontakt:
- Shengqing He
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Chongqing, Čína, China
- PLA Army Characteristic Medical Center
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Kontakt:
- hao Tang
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Chongqing, Čína, China
- The First Affiliated Hospital of Army Medical University
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Dílčí vyšetřovatel:
- Liang Tan, MD
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Dílčí vyšetřovatel:
- Yonghui Zhang, MB
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Dílčí vyšetřovatel:
- Yan Zhang, MB
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Dílčí vyšetřovatel:
- Ying Cao, MB
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Dílčí vyšetřovatel:
- Weiguang Zhang, MM
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Dílčí vyšetřovatel:
- Dongfang Yang, MM
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Dílčí vyšetřovatel:
- Lenv Gao, MD
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Kontakt:
- Liang Tan
- Telefonní číslo: +86-158-2354-0630
- E-mail: liangtan@tmmu.edu.cn
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Vrchní vyšetřovatel:
- Changlin Yin, MD
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Dílčí vyšetřovatel:
- Lan Cheng, MM
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Dílčí vyšetřovatel:
- Ya Wang, MM
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Chongqing, Čína, China
- The People's Hospital of Rongchang District
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Kontakt:
- dan Li
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Chongqing, Čína, China
- The Second Affiliated Hospital of Chongqing Medical University
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Kontakt:
- chenyang Duan
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Jiangsu
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Nanjing, Jiangsu, Čína, China
- Eastern Theater Command General Hospital
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Kontakt:
- Lu Ke
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Sichuan
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Panzhihua, Sichuan, Čína, China
- Panzhihua Central Hospital
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Kontakt:
- xiaodong Deng
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Provision of informed consent
- Age 18 years or older
- Expected ICU discharge within 24 hours
- APACHE II score of 15 or higher at ICU admission
- Received mechanical ventilation for at least 6 hours during the current ICU stay
- Duration of the current ICU stay of more than 48 hours and no more than 28 days
- Enteral nutrition has been initiated
- Able to cooperate with study-related assessments and follow-up, including simple bedside activities such as sitting, standing, or short-distance walking independently or with assistance.
Exclusion Criteria:
- Expected death or withdrawal of life-sustaining treatment within 48 hours after ICU discharge
- Severe liver failure (Child-Pugh class C) at ICU discharge
- Chronic kidney disease with creatinine clearance less than 40 mL/min at ICU discharge
- Pregnant or breastfeeding
- Unable to walk independently before ICU admission, except those able to walk independently with a walking aid
- Acute-phase traumatic brain injury, primary cerebrovascular disease, brain tumor, or intracranial infection
- Primary cognitive impairment, including Alzheimer's disease, vascular dementia, hydrocephalus, or other severe central nervous system disease
- History of psychiatric or psychological disorders such as depression, anxiety, or schizophrenia
- History of cardiopulmonary arrest
- Lower limb injury, systemic neuromuscular disease, or spinal condition that may affect outcome assessment
- Current use of other Chinese herbal medicines or proprietary Chinese medicines intended to tonify qi and nourish blood
- Known allergy to Fufang E'jiao Jiang or any of its components
- Active gastrointestinal bleeding
- Body mass index less than 16.0 kg/m² or 40.0 kg/m² or higher
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Fufang Ejiao Jiang
Participants will receive Fufang Ejiao Jiang, 20 mL orally three times daily for 90 consecutive days |
Oral liquid, 20 mL by mouth three times daily for 90 consecutive days. |
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Komparátor placeba: placebo
Participants will receive a matching placebo, 20 mL orally three times daily for 90 consecutive days |
Oral liquid placebo, 20 mL by mouth three times daily for 90 consecutive days. The placebo is matched to Fufang Ejiao Jiang in appearance, packaging, color, and taste and contains no active ingredients of Fufang Ejiao Jiang Other Name: |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Win Ratio for the 90-Day Hierarchical Composite Outcome
Časové okno: From randomization through day 90
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The primary outcome is a single prespecified hierarchical composite endpoint analyzed using the win ratio method. Participants from the two randomized groups will be compared pairwise according to the following clinical priority hierarchy: (1) all-cause mortality within 90 days after randomization; (2) unplanned all-cause readmission within 90 days after randomization; and (3) change from baseline in the EQ-5D-5L utility index at day 90. Comparisons will proceed to the next component when no winner is determined at the preceding level. The primary treatment effect will be expressed as a single win ratio, calculated as the ratio of winning to losing pairs. The three components constitute one hierarchical composite endpoint rather than three separate primary outcome measures. |
From randomization through day 90
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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6-minute walk test distance
Časové okno: At baseline, 30 days after randomization, and 90 days after randomization
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Exercise tolerance assessed using the 6-minute walk test |
At baseline, 30 days after randomization, and 90 days after randomization
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Clinical Frailty Scale score
Časové okno: At baseline, 30 days after randomization, and 90 days after randomization
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Frailty assessed using the Clinical Frailty Scale |
At baseline, 30 days after randomization, and 90 days after randomization
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Montreal Cognitive Assessment score
Časové okno: At baseline, 30 days after randomization, and 90 days after randomization
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Cognitive function assessed using the Montreal Cognitive Assessment |
At baseline, 30 days after randomization, and 90 days after randomization
|
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Fatigue Severity Scale score
Časové okno: At baseline, 30 days after randomization, and 90 days after randomization
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Fatigue assessed using the Fatigue Severity Scale |
At baseline, 30 days after randomization, and 90 days after randomization
|
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Hospital Anxiety and Depression Scale score
Časové okno: At baseline, 30 days after randomization, and 90 days after randomization
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Psychological symptoms assessed using the Hospital Anxiety and Depression Scale |
At baseline, 30 days after randomization, and 90 days after randomization
|
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Total Sleep Time Measured by Wrist Actigraphy
Časové okno: At baseline, 30 days after randomization, and 90 days after randomization.
|
Total sleep time will be assessed using a wearable sleep wristband (actigraphy) and reported in minutes. |
At baseline, 30 days after randomization, and 90 days after randomization.
|
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Sleep Efficiency Measured by Wrist Actigraphy
Časové okno: At baseline, 30 days after randomization, and 90 days after randomization.
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Sleep efficiency will be assessed using a wearable sleep wristband (actigraphy) and reported as a percentage. |
At baseline, 30 days after randomization, and 90 days after randomization.
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Wake After Sleep Onset Measured by Wrist Actigraphy
Časové okno: At baseline, 30 days after randomization, and 90 days after randomization.
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Wake after sleep onset (WASO) will be assessed using a wearable sleep wristband (actigraphy) and reported in minutes. |
At baseline, 30 days after randomization, and 90 days after randomization.
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Global Score on the Pittsburgh Sleep Quality Index (PSQI)
Časové okno: At baseline, 30 days after randomization, and 90 days after randomization.
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Subjective sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The global score ranges from 0 to 21, with higher scores indicating poorer sleep quality. |
At baseline, 30 days after randomization, and 90 days after randomization.
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Appetite
Časové okno: At baseline, 30 days after randomization, and 90 days after randomization
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Appetite will be assessed using the Simplified Nutritional Appetite Questionnaire (SNAQ), a 4-item self-administered instrument covering appetite, feelings of fullness, taste of food, and number of meals per day. The total score ranges from 4 to 20; a score of 14 or lower indicates a significant risk of at least 5% weight loss within 6 months, with lower scores indicating poorer appetite. |
At baseline, 30 days after randomization, and 90 days after randomization
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Handgrip strength
Časové okno: At baseline, 30 days after randomization, and 90 days after randomization
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Muscle strength assessed by handgrip dynamometry |
At baseline, 30 days after randomization, and 90 days after randomization
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Body Fat Percentage Measured by Nutrilab Body Composition Analysis
Časové okno: At baseline, day 30, and day 90 after randomization.
|
Body fat percentage will be measured using the Nutrilab body composition analysis system and reported as the percentage of total body weight consisting of fat mass. |
At baseline, day 30, and day 90 after randomization.
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Fat Mass Measured by Nutrilab Body Composition Analysis
Časové okno: At baseline, day 30, and day 90 after randomization.
|
Total body fat mass will be measured using the Nutrilab body composition analysis system and reported in kilograms. |
At baseline, day 30, and day 90 after randomization.
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Skeletal Muscle Mass Measured by Nutrilab Body Composition Analysis
Časové okno: At baseline, day 30, and day 90 after randomization.
|
Skeletal muscle mass will be measured using the Nutrilab body composition analysis system and reported in kilograms. |
At baseline, day 30, and day 90 after randomization.
|
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Fat-Free Mass Measured by Nutrilab Body Composition Analysis
Časové okno: At baseline, day 30, and day 90 after randomization.
|
Fat-free mass will be measured using the Nutrilab body composition analysis system and reported in kilograms. |
At baseline, day 30, and day 90 after randomization.
|
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Hemoglobin Concentration
Časové okno: At baseline and day 90 after randomization.
|
Hemoglobin concentration will be measured in whole blood using routine complete blood count (CBC) analysis and reported in g/L. |
At baseline and day 90 after randomization.
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Albumin Concentration
Časové okno: At baseline and day 90 after randomization.
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Albumin concentration will be measured by routine clinical laboratory analysis and reported in g/L. |
At baseline and day 90 after randomization.
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Prealbumin Concentration
Časové okno: At baseline and day 90 after randomization.
|
Prealbumin concentration will be measured by routine clinical laboratory analysis and reported in mg/L. |
At baseline and day 90 after randomization.
|
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C-Reactive Protein Concentration
Časové okno: At baseline and day 90 after randomization.
|
C-reactive protein (CRP) concentration will be measured by routine clinical laboratory analysis and reported in mg/L. |
At baseline and day 90 after randomization.
|
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Creatinine Concentration
Časové okno: At baseline and day 90 after randomization.
|
Creatinine concentration will be measured by routine clinical laboratory analysis and reported in µmol/L. |
At baseline and day 90 after randomization.
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Blood Urea Nitrogen Concentration
Časové okno: At baseline and day 90 after randomization.
|
Blood urea nitrogen (BUN) concentration will be measured by routine clinical laboratory analysis and reported in mmol/L. |
At baseline and day 90 after randomization.
|
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Red Blood Cell Count
Časové okno: At baseline and day 90 after randomization.
|
Red blood cell count will be measured in whole blood using routine complete blood count (CBC) analysis and reported in 10^12 cells/L. |
At baseline and day 90 after randomization.
|
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Absolute Lymphocyte Count
Časové okno: At baseline and day 90 after randomization.
|
Absolute lymphocyte count will be measured in whole blood using routine hematological analysis and reported in 10^9 cells/L. |
At baseline and day 90 after randomization.
|
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White Blood Cell Count
Časové okno: At baseline and day 90 after randomization.
|
White blood cell count will be measured in whole blood using routine complete blood count (CBC) analysis and reported in 10^9 cells/L. |
At baseline and day 90 after randomization.
|
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Percentage of HLA-DR-Positive Cells
Časové okno: At baseline and day 90 after randomization.
|
The percentage of HLA-DR-positive monocytes will be assessed in peripheral blood using flow cytometry. HLA-DR-positive monocytes will be quantified as a percentage of the total monocyte population, with higher percentages indicating a greater proportion of monocytes expressing HLA-DR. |
At baseline and day 90 after randomization.
|
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Absolute Reticulocyte Count
Časové okno: At baseline and day 90 after randomization.
|
Absolute reticulocyte count will be measured in peripheral whole blood using an automated hematology analyzer and reported in 10^9 cells/L. |
At baseline and day 90 after randomization.
|
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Reticulocyte Hemoglobin Content (RET-He or CHr)
Časové okno: At baseline and day 90 after randomization.
|
Reticulocyte hemoglobin content will be measured in peripheral whole blood using an automated hematology analyzer and reported in picograms (pg) per reticulocyte. The parameter will be reported as reticulocyte hemoglobin equivalent (RET-He) or reticulocyte hemoglobin content (CHr), depending on the analyzer used. |
At baseline and day 90 after randomization.
|
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Serum Ferritin Concentration
Časové okno: At baseline and day 90 after randomization.
|
Serum ferritin concentration will be measured using a clinical laboratory immunoassay and reported in ng/mL. |
At baseline and day 90 after randomization.
|
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Transferrin Saturation (TSAT)
Časové okno: At baseline and day 90 after randomization.
|
Transferrin saturation (TSAT) will be calculated from serum iron concentration and total iron-binding capacity (TIBC) using the formula: TSAT (%) = [serum iron / TIBC] × 100, with both measurements expressed in the same units. TIBC will be measured directly or calculated from serum transferrin concentration using the validated laboratory-specific method. TSAT will be reported as a percentage. |
At baseline and day 90 after randomization.
|
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Plasma Growth Differentiation Factor 15 (GDF15) Concentration
Časové okno: At baseline and day 90 after randomization.
|
Plasma growth differentiation factor 15 (GDF15) concentration will be measured using a validated immunoassay and reported in pg/mL. |
At baseline and day 90 after randomization.
|
Spolupracovníci a vyšetřovatelé
Publikace a užitečné odkazy
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Termíny studijních záznamů
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