CClinicalTrials.gg
Not yet recruitingNCT07865039Updated Oct 8, 2026

Inflammatory Markers and Pain in Sickle Cell Disease

An observational study in Sickle Cell Disease, sponsored by Assiut University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.

Sponsored by Assiut University · Observational

Updated Oct 8, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
75
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Sickle Cell Disease

Browse trials for

03

In context

Anemia, Sickle Cell

1,103 studies on the registry are indexed under Anemia, Sickle Cell; 235 are open to participants now.

This study's planned enrollment of 75 is below the median of 100 across 287 observational studies indexed under Anemia, Sickle Cell.

Browse Anemia, Sickle Cell studies →

Lead sponsor

Assiut University is the lead sponsor of 4,916 studies on the registry; 2,113 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients with confirmed sickle cell disease who present to Assiut University Hospitals during the study period. Participants will include patients in different clinical presentations, including steady state and vaso-occlusive crisis. Eligible patients will be enrolled according to the predefined inclusion and exclusion criteria.

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

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.
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
75 participants (estimated)
Patient registry
No

Groups and cohorts

  • Adult Patients with Sickle Cell Disease

    Adult 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.

06

What researchers measure

Primary outcomes

  1. 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.

    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.

    Time frame: At enrollment

07

Study locations

1 site
08

References and documents

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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 30332562 ↗
  • Conran N, Belcher JD. Inflammation in sickle cell disease. Clin Hemorheol Microcirc. 2018;68(2-3):263-299. doi: 10.3233/CH-189012. PubMed 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. PubMed 29542687 ↗
09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 8, 2026
Show all 1 update
  1. Oct 8, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07865039
Lead sponsor
Assiut University
Responsible party
Mohammed El-Sayed Mahmoud Ahmed (Resident doctor at assuit university hospital - internal medicine department, Assiut University) — Principal investigator
First posted
Oct 8, 2026
Start date
Nov 2026 (estimated)
Primary completion
Mar 2029 (estimated)
Completion
May 2029 (estimated)
Last update
Oct 8, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion