NCT07180836

Brief Summary

This study aimed to determine the prevalence and hematological characteristics of hemoglobinopathies in Mardan and surrounding districts of Khyber Pakhtunkhwa (KPK), Pakistan. A descriptive cross-sectional design was conducted at Mardan Medical Complex from January 2021 to January 2023. Blood samples were analyzed using High Performance Liquid Chromatography (HPLC) on the Bio-Rad D-10 analyzer, with complete blood counts performed using Sysmex XN1000. A total of 839 participants were enrolled in this study. The study highlights differences in hematological parameters across hemoglobinopathy types and provides region-specific data to inform public health interventions and screening programs.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
839

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2023

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2023

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 18, 2025

Completed
Last Updated

September 18, 2025

Status Verified

August 1, 2025

Enrollment Period

2 years

First QC Date

August 30, 2025

Last Update Submit

September 17, 2025

Conditions

Keywords

HemoglobinopathiesThalassemiaSickle cell disease

Outcome Measures

Primary Outcomes (1)

  • Prevalence of Hemoglobinopathies.

    Number of patients diagnosed with each hemoglobinopathy type (e.g., β-thalassemia trait, sickle cell disease, HbE).

    At the time of diagnosis / Single assessment at enrollment

Secondary Outcomes (1)

  • Demographic Distribution of Hemoglobinopathies by Age, Gender, and Geographic Area

    At the time of diagnosis / Single assessment at enrollment

Study Arms (1)

Patients with Hemoglobinopathies in Mardan and Surrounding Districts

This cohort includes patients diagnosed with various hemoglobinopathies in Mardan and neighboring districts of Khyber Pakhtunkhwa, Pakistan. Participants were assessed for prevalence and hematological characteristics, including complete blood count parameters and disease-specific findings. No intervention was applied; this is an observational, cross-sectional study focused on identifying distribution patterns and hematological profiles of hemoglobinopathies in the study population

Other: No Intervention (Observational Study)

Interventions

This is an observational, cross-sectional study. Patients with suspected or confirmed hemoglobinopathies were evaluated for prevalence and hematological characteristics using laboratory investigations, without any experimental treatment or therapeutic intervention applied.

Patients with Hemoglobinopathies in Mardan and Surrounding Districts

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population consisted of patients referred for hemoglobinopathy testing to the Hematology Department, Mardan Medical Complex, Mardan, Khyber Pakhtunkhwa, Pakistan, over a period of two years (January 2021 to January 2023). A total of 839 participants were included in the analysis. These patients were of varying ages (mean age: 10.25 ± 4.87 years), with 55.89% male and 43.87% female, and represented different districts including Mardan, Charsadda, Dir, Buner, and Swabi, with the majority from Mardan (86.41%).

You may qualify if:

  • All patients referred to the Hematology Department of Mardan Medical Complex for hemoglobinopathy testing between Jan 2021 - Jan 2023.
  • Patients of either sex.
  • Patients who underwent high-performance liquid chromatography (HPLC) and complete blood count (CBC) analysis.

You may not qualify if:

  • Patients with incomplete or missing laboratory data (CBC or HPLC).
  • Patients in whom hemoglobinopathy diagnosis could not be confirmed.
  • Cases of anemia due to non-hemoglobinopathy causes (e.g., nutritional anemia, chronic disease).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mardan Medical Comlex, Mardan

Mardan, KPK, 23200, Pakistan

Location

MeSH Terms

Conditions

HemoglobinopathiesThalassemiaAnemia, Sickle Cell

Interventions

Observation

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesAnemia, Hemolytic, CongenitalAnemia, HemolyticAnemia

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Malik Shayan Ali Khan, MBBS

    Bacha Khan Medical College, Mardan.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor (Principal Investigator)

Study Record Dates

First Submitted

August 30, 2025

First Posted

September 18, 2025

Study Start

January 15, 2021

Primary Completion

January 15, 2023

Study Completion

January 20, 2023

Last Updated

September 18, 2025

Record last verified: 2025-08

Locations