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  string(109) "AERATE-IPF: An Individual Participant Data Meta-Analysis of Erythrocytosis Rates And Treatment Effects in IPF"
  ["project_narrative_summary"]=>
  string(547) "Idiopathic pulmonary fibrosis (IPF) is a progressive lung disease associated with chronic hypoxia and secondary erythrocytosis. However, the prevalence and clinical implications of erythrocytosis in IPF remain unclear. This study aims to assess baseline rates of erythrocytosis in patients with IPF and evaluate changes in hemoglobin/hematocrit and related laboratory markers with treatment. Using patient-level data from 5 clinical trials, we will explore correlations with thrombosis risk and assess whether erythrocytosis improves with therapy."
  ["project_learn_source"]=>
  string(12) "scien_public"
  ["principal_investigator"]=>
  array(7) {
    ["first_name"]=>
    string(8) "Benjamin"
    ["last_name"]=>
    string(8) "Chin-Yee"
    ["degree"]=>
    string(9) "MD, FRCPC"
    ["primary_affiliation"]=>
    string(49) "Western University, London Health Sciences Centre"
    ["email"]=>
    string(28) "benjamin.chin-yee@lhsc.on.ca"
    ["state_or_province"]=>
    string(7) "Ontario"
    ["country"]=>
    string(6) "Canada"
  }
  ["project_key_personnel"]=>
  array(3) {
    [0]=>
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      ["p_pers_f_name"]=>
      string(5) "Cyrus"
      ["p_pers_l_name"]=>
      string(4) "Hsia"
      ["p_pers_degree"]=>
      string(9) "MD, FRCPC"
      ["p_pers_pr_affil"]=>
      string(49) "Western University, London Health Sciences Centre"
      ["p_pers_scop_id"]=>
      string(0) ""
      ["requires_data_access"]=>
      string(3) "yes"
    }
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      ["p_pers_f_name"]=>
      string(9) "Jenyvette"
      ["p_pers_l_name"]=>
      string(4) "Hsia"
      ["p_pers_degree"]=>
      string(3) "N/A"
      ["p_pers_pr_affil"]=>
      string(98) "Western University, Department of Pathology and Laboratory Medicine, London Health Sciences Centre"
      ["p_pers_scop_id"]=>
      string(0) ""
      ["requires_data_access"]=>
      string(3) "yes"
    }
    [2]=>
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      ["p_pers_f_name"]=>
      string(4) "Ella"
      ["p_pers_l_name"]=>
      string(7) "Derkzen"
      ["p_pers_degree"]=>
      string(3) "N/A"
      ["p_pers_pr_affil"]=>
      string(98) "Western University, Department of Pathology and Laboratory Medicine, London Health Sciences Centre"
      ["p_pers_scop_id"]=>
      string(0) ""
      ["requires_data_access"]=>
      string(3) "yes"
    }
  }
  ["project_ext_grants"]=>
  array(2) {
    ["value"]=>
    string(2) "no"
    ["label"]=>
    string(68) "No external grants or funds are being used to support this research."
  }
  ["project_date_type"]=>
  string(18) "full_crs_supp_docs"
  ["property_scientific_abstract"]=>
  string(1455) "Background: Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive interstitial lung disease associated with impaired gas exchange and systemic hypoxia. Secondary erythrocytosis is a long-recognized clinical feature of hypoxic lung diseases, including IPF, but it has not been systematically studied in the context of clinical trial populations.



Objective: To evaluate the prevalence of erythrocytosis and longitudinal changes of hemoglobin and hematocrit in patients with IPF, and to assess the impact of treatment on these parameters. Secondary objectives include exploring the association between elevated hematocrit/hemoglobin and thrombotic outcomes.



Study Design: Individual participant-level data meta-analysis of 5 randomized clinical trials investigating bosentan or macitentan in IPF.



Participants: Adults enrolled in IPF trials with available baseline hematocrit or hemoglobin data and other relevant clinical or laboratory parameters.



Primary and Secondary Outcome Measures: The primary outcome is the prevalence of elevated hematocrit/hemoglobin at baseline, defined using standard WHO sex-based criteria (1). Secondary outcomes include changes in these values over time with treatment, and incidence of thrombotic events (venous and arterial) in relation to hematocrit and hemoglobin levels.



Statistical Analysis: 

(Please see Supplementary Materials.)"
  ["project_brief_bg"]=>
  string(2884) "Secondary erythrocytosis is a physiologic response to chronic hypoxemia, driven by increased erythropoietin production and red blood cell mass expansion to improve oxygen delivery. This response has been described in various hypoxic lung diseases, including chronic obstructive pulmonary disease (COPD), sleep apnea, and high-altitude pulmonary syndromes. In COPD, for example, secondary polycythemia has been observed in 9.2% of males and 3.5% of females, and long-term oxygen therapy was found to be protective (Zhang et al. 2021). Although polycythemia may enhance oxygen-carrying capacity, it may also lead to increased blood viscosity and increased vascular risk, though direct evidence in chronic lung diseases remains limited.



Idiopathic pulmonary fibrosis (IPF) is a progressive interstitial lung disease characterized by worsening dyspnea, declining lung function, and impaired gas exchange. While anemia is frequently observed in IPF, the prevalence and clinical impact of secondary erythrocytosis remain poorly defined. A small observational study from Mexico City—where patients resided at high altitude—reported erythrocytosis in over 60% of individuals with IPF, suggesting that elevated hemoglobin and hematocrit may occur in this population under certain environmental conditions (Perez-Padilla et al. 1992). More recent studies suggest that erythrocytosis is less common in IPF, though prevalence varies. A comparative study of IPF and COPD patients with chronic respiratory failure found that while 59% of COPD patients exhibited polycythemia, only 18% of IPF patients had elevated hematocrit, suggesting a blunted erythropoietic response in IPF (Tassiopoulos et al., 2001). A retrospective review in the United States reported rates of polycythemia of 10% in patients with IPF (Mosburg et al., 2009); by contrast, a prospective study from Egypt reported anemia in 38% of IPF patients and no significant incidence of polycythemia (Abdelaziz et al. 2018). These conflicting findings, with a wide range of reported prevalence, underscore the need for updated, systematic evaluation of erythrocytosis in contemporary, trial-defined IPF populations.



This project aims to address that gap by evaluating hematocrit and hemoglobin values in participants from 5 randomized clinical trials of bosentan and macitentan in IPF. Using individual participant-level data, we will assess the prevalence of erythrocytosis, track changes over time with treatment, and explore associations with outcomes including thrombotic events. By providing high-quality, contemporary data on erythrocytosis in IPF, this study will improve our understanding of its frequency, clinical relevance, and response to therapy. Findings may help guide decisions regarding laboratory monitoring, oxygen therapy, and management of vascular risk in this population.

"
  ["project_specific_aims"]=>
  string(1349) "Study Objectives:

To assess the prevalence and longitudinal changes in hematologic parameters—specifically hemoglobin and hematocrit—in patients with IPF enrolled in 5 clinical trials of bosentan and macitentan, and to evaluate associations between erythrocytosis and clinical outcomes including thrombosis.



Specific Hypotheses:

1.	A subset of patients with IPF exhibit erythrocytosis at baseline as defined by WHO sex-specific thresholds.

2.	Hematocrit and hemoglobin levels change over time in response to treatment with bosentan or macitentan.

3.	Erythrocytosis in IPF is associated with higher risk of thrombotic events (venous or arterial).

4.	Erythrocytosis is associated with demographic and clinical factors such as age, sex, body mass index (BMI), smoking status, and pulmonary function.

5.	Use of long-term oxygen therapy is associated with lower rates of erythrocytosis in IPF.

6.	Patients with higher baseline hemoglobin/hematocrit have distinct clinical profiles compared to those without erythrocytosis.

7.	Erythrocytosis in IPF is less prevalent than in other hypoxic lung diseases, but its clinical consequences may be significant.

8.	Hemoglobin and hematocrit trajectories may serve as biomarkers of disease progression or response to therapy in IPF."
  ["project_study_design"]=>
  array(2) {
    ["value"]=>
    string(7) "meta_an"
    ["label"]=>
    string(52) "Meta-analysis (analysis of multiple trials together)"
  }
  ["project_purposes"]=>
  array(4) {
    [0]=>
    array(2) {
      ["value"]=>
      string(56) "new_research_question_to_examine_treatment_effectiveness"
      ["label"]=>
      string(114) "New research question to examine treatment effectiveness on secondary endpoints and/or within subgroup populations"
    }
    [1]=>
    array(2) {
      ["value"]=>
      string(49) "new_research_question_to_examine_treatment_safety"
      ["label"]=>
      string(49) "New research question to examine treatment safety"
    }
    [2]=>
    array(2) {
      ["value"]=>
      string(22) "participant_level_data"
      ["label"]=>
      string(36) "Participant-level data meta-analysis"
    }
    [3]=>
    array(2) {
      ["value"]=>
      string(37) "participant_level_data_only_from_yoda"
      ["label"]=>
      string(51) "Meta-analysis using only data from the YODA Project"
    }
  }
  ["project_research_methods"]=>
  string(677) "We will perform a pooled individual participant-level data analysis using five randomized clinical trials of bosentan and macitentan in patients with idiopathic pulmonary fibrosis (IPF).



Inclusion criteria for trials: Trials will be included if they enrolled patients with IPF and collected baseline data on hemoglobin and/or hematocrit. Availability of other variables (e.g., age, sex, BMI, smoking status, comorbidities, thrombotic events, or oxygen use) will be considered advantageous for secondary analyses.



Exclusion criteria for trials: Trials that did not include hematocrit or hemoglobin data at baseline will be excluded.



"
  ["project_main_outcome_measure"]=>
  string(794) "Primary Outcome:

•	Prevalence of erythrocytosis at baseline, defined by sex-specific WHO thresholds:

o	Hemoglobin >16.5 g/dL or hematocrit >49% in men

o	Hemoglobin >16.0 g/dL or hematocrit >48% in women



Secondary Outcomes:

•	Longitudinal changes in hemoglobin and hematocrit values during treatment

•	Association between erythrocytosis and incidence of thrombotic events (arterial and venous)

•	Associations between erythrocytosis and demographic/clinical variables (age, sex, BMI, smoking, pulmonary function)

•	Relationship between oxygen therapy use and erythrocytosis prevalence

•	Comparison of outcomes (e.g., mortality, hospitalization) between patients with and without erythrocytosis

"
  ["project_main_predictor_indep"]=>
  string(350) "Primary predictors: Hemoglobin and hematocrit (continuous) and erythrocytosis (categorical, per WHO criteria)



Other independent variables: Age, sex, BMI, smoking status, oxygen use, pulmonary function tests



Dependent variables: Thrombotic events, mortality, and longitudinal changes in hematologic values



"
  ["project_other_variables_interest"]=>
  string(4) "None"
  ["project_stat_analysis_plan"]=>
  string(831) "Descriptive statistics will be used to summarize baseline characteristics and prevalence of erythrocytosis. Comparisons between groups (with vs. without erythrocytosis) will be conducted using chi-square or Fisher’s exact test for categorical variables and t-tests or Wilcoxon rank-sum tests for continuous variables. Paired analyses (e.g., before and after treatment) will use paired t-tests or Wilcoxon signed-rank tests.



Longitudinal changes in hemoglobin/hematocrit will be analyzed using mixed-effects models or repeated-measures ANOVA. Multivariable logistic and Cox regression models will assess associations between erythrocytosis and thrombotic events, adjusting for potential confounders. Sensitivity analyses will evaluate outcomes using different thresholds for defining erythrocytosis.



"
  ["project_software_used"]=>
  array(1) {
    [0]=>
    array(2) {
      ["value"]=>
      string(5) "stata"
      ["label"]=>
      string(5) "STATA"
    }
  }
  ["project_timeline"]=>
  string(271) "The proposed research will begin once approved. Data analyses will be completed within 3 months. Manuscript drafting will take a further 3 months and we will prepare for manuscript submission.  Once manuscript submitted, results will be reported back to the YODA Project."
  ["project_dissemination_plan"]=>
  string(463) "The study will provide contemporary evidence on the prevalence and clinical relevance of erythrocytosis in IPF, potentially informing monitoring and treatment strategies. We plan to submit the findings to a high-impact hematology or pulmonology journal such as Blood, Blood Advances, American Journal of Hematology, Lancet Haematology, Thorax, CHEST, Lancet Respiratory Medicine. Findings will also be presented at major conferences such as ASH, EHA, ATS, or ERS."
  ["project_bibliography"]=>
  string(1663) "

Arber DA, Orazi A, Hasserjian R, et al. The 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia. Blood. 2016;127(20):2391–405. doi:10.1182/blood-2016-03-643544

 

Zhang J, DeMeo DL, Silverman EK, Make BJ, Wade RC, Wells JM, Cho MH, Hobbs BD. Secondary polycythemia in chronic obstructive pulmonary disease: prevalence and risk factors. BMC Pulm Med. 2021;21(1):235. doi:10.1186/s12890-021-01585-5

 

Pérez-Padilla R, Salas J, Carrillo G, Selman M, Chapela R. Prevalence of high hematocrits in patients with interstitial lung disease in Mexico City. Chest. 1992;101(6):1691–3. doi:10.1378/chest.101.6.1691

 

Tassiopoulos S, Kontos A, Konstantopoulos K, Hadzistavrou C, Vaiopoulos G, Aessopos A, Tassiopoulos T. Erythropoietic response to hypoxaemia in diffuse idiopathic pulmonary fibrosis, as opposed to chronic obstructive pulmonary disease. Respir Med. 2001;95(6):471–5. doi:10.1053/rmed.2001.1070

 

Abdelaziz AO, Abd El-Ghany EA, Makram O, Abd El-Aziz MO, El-Hoseany MM, El-Sharkawy E. Prevalence and impact of anemia in patients with chronic respiratory diseases. Egypt J Chest Dis Tuberc. 2018;67(4):461–70. doi:10.4103/ejcdt.ejcdt_39_17

 

Mosburg D, Campochiaro C, Nathan SD. Prevalence and impact of anemia and polycythemia in patients with idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2009;179:A4051.

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