Inflammatory Markers and Pain in Sickle Cell Disease

NCT07865039 — Not yet recruiting, 75 participants, Assiut University

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Association Between Inflammatory Markers and Pain Intensity in Patients With Sickle Cell Disease

RegistryNCT07865039
StatusNot yet recruiting
Study typeObservational
Enrollment75 (Estimated)
SponsorAssiut University (Other)
ConditionsSickle Cell Disease
Datesstart 2026-11-01 (estimated), primary completion 2029-03-01 (estimated), completion 2029-05-01 (estimated), first posted 2026-10-08, last updated 2026-10-08
Locations1 site in Egypt

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-Summary

This observational cross-sectional study aims to assess the relationship between inflammatory markers and pain intensity in adult patients with sickle cell disease. The study will evaluate inflammatory markers in patients with different clinical presentations, including steady state and vaso-occlusive crisis.

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+Detailed description

Sickle cell disease is a chronic hematological disorder characterized by recurrent complications, including painful vaso-occlusive crises. Inflammatory and hematological markers may vary according to the clinical state and may be associated with the severity of pain.

This observational cross-sectional study will evaluate adult patients with sickle cell disease presenting in different clinical states, including steady state and vaso-occlusive crisis. Clinical history and examination findings will be recorded, including pain intensity assessed using the Visual Analog Scale (VAS), type of clinical presentation, duration of crisis, and length of hospital stay when applicable.

Laboratory investigations will include complete blood count with differential, from which neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR) will be calculated, as well as C-reactive protein (CRP), lactate dehydrogenase (LDH), and D-dimer. Other relevant routine laboratory investigations will also be recorded when available.

The study will assess the association between inflammatory markers and pain intensity and will compare these markers among different clinical presentations, particularly steady state and vaso-occlusive crisis. The study will also explore relationships between these markers and relevant hematological and biochemical parameters.

+Arms and interventions

ArmTypeInterventionsDescription
Adult Patients with Sickle Cell DiseaseAdult patients with sickle cell disease will be evaluated according to their clinical presentation, including steady state and vaso-occlusive crisis. Clinical data, pain intensity, and relevant laboratory parameters including inflammatory and hematological markers will be assessed. No intervention will be assigned as part of the study.

+Outcome measures

Primary outcomes

  • To determine the association between NLR, PLR, and CRP levels and pain intensity, as assessed by the Visual Analogue Scale (VAS), among adult patients with sickle cell disease. [At enrollment]: Pain intensity will be assessed using the Visual Analog Scale (VAS), and its association with neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and C-reactive protein (CRP) levels will be evaluated in adult patients with sickle cell disease.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Adults aged ≥18 years. Confirmed diagnosis of sickle cell disease. Patients attending or admitted to the Internal Medicine Department during the study period.

Willingness to participate and provide informed consent.

Exclusion Criteria:

* Patients younger than 18 years. Acute infection or sepsis Autoimmune or chronic inflammatory diseases. Malignancy End-stage renal disease on dialysis. Chronic liver disease Blood transfusion within the preceding four weeks Recent surgery or trauma (within the preceding four weeks. Refusal to participate.

+Locations (1)

FacilityCityCountryStatus
Assiut University HospitalsAsyut, Asyut GovernorateEgypt

+Publications

  • Mirbeyk M, Misra S, Koneru G, Funaro MC, Rangaraju S, Bakshi N. Blood-based protein biomarkers of sickle cell disease pain: a systematic review and meta-analysis. Pain. 2026 Jan 1;167(1):56-74. doi: 10.1097/j.pain.0000000000003773. Epub 2025 Oct 1. PMID 40981515
  • Lard LR, Mul FP, de Haas M, Roos D, Duits AJ. Neutrophil activation in sickle cell disease. J Leukoc Biol. 1999 Sep;66(3):411-5. doi: 10.1002/jlb.66.3.411. PMID 10496310
  • Krishnan S, Setty Y, Betal SG, Vijender V, Rao K, Dampier C, Stuart M. Increased levels of the inflammatory biomarker C-reactive protein at baseline are associated with childhood sickle cell vasocclusive crises. Br J Haematol. 2010 Mar;148(5):797-804. doi: 10.1111/j.1365-2141.2009.08013.x. Epub 2009 Dec 8. PMID 19995398
  • Nader E, Romana M, Connes P. The Red Blood Cell-Inflammation Vicious Circle in Sickle Cell Disease. Front Immunol. 2020 Mar 13;11:454. doi: 10.3389/fimmu.2020.00454. eCollection 2020. PMID 32231672
  • Sundd P, Gladwin MT, Novelli EM. Pathophysiology of Sickle Cell Disease. Annu Rev Pathol. 2019 Jan 24;14:263-292. doi: 10.1146/annurev-pathmechdis-012418-012838. Epub 2018 Oct 17. PMID 30332562
  • Conran N, Belcher JD. Inflammation in sickle cell disease. Clin Hemorheol Microcirc. 2018;68(2-3):263-299. doi: 10.3233/CH-189012. PMID 29614637
  • Kato GJ, Piel FB, Reid CD, Gaston MH, Ohene-Frempong K, Krishnamurti L, Smith WR, Panepinto JA, Weatherall DJ, Costa FF, Vichinsky EP. Sickle cell disease. Nat Rev Dis Primers. 2018 Mar 15;4:18010. doi: 10.1038/nrdp.2018.10. PMID 29542687