HemoglobinopathiesNCT07180836
Prevalence and Hematological Characteristics of Hemoglobinopathies
An observational study of Hemoglobinopathies, run by Bacha Khan Medical College at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Hemoglobinopathies
- How many people
- 839 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jan 2021to 20 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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%).
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence and Hematological Characteristics of Hemoglobinopathies: A Cross-Sectional Study From a Tertiary Care Hospital
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.
Read the detailed description
Hemoglobinopathies are among the most common inherited disorders worldwide, caused by mutations in globin genes affecting hemoglobin synthesis, structure, and function. They are highly prevalent in South Asia, particularly in Pakistan, where beta-thalassemia is the most frequent single-gene disorder. Despite this, there is limited epidemiological data from Khyber Pakhtunkhwa (KPK), especially in Mardan, where consanguineous marriages are common and contribute to disease burden.
This descriptive cross-sectional study was conducted over a two-year period (January 2021 to January 2023) at the hematology department of Mardan Medical Complex, Pakistan. All patients referred for hemoglobinopathy testing were included. Blood samples (3 mL EDTA) were collected and analyzed for complete blood counts (hemoglobin, RBC count, hematocrit, MCV, MCH, MCHC) using Sysmex XN1000, and hemoglobin variants were identified using High Performance Liquid Chromatography (Bio-Rad D-10 analyzer). A sickling test was performed in cases with abnormal S-window chromatogram findings.
A total of 839 participants were analyzed. Geographic distribution was showed for patients from different nearby regions .
This study provides the first comprehensive regional overview of hemoglobinopathies in Mardan, KPK. The findings of our study will emphasize the need for early detection, genetic counseling, and preventive public health strategies, particularly in communities with high rates of consanguinity. These results might support the development of targeted screening and awareness programs to reduce the burden of hemoglobinopathies in Pakistan.
- Conditions
- Hemoglobinopathies
- Being tested
- No Intervention (Observational Study)
- Keywords
- Hemoglobinopathies, Thalassemia, Sickle cell disease
- Medical subject headings
- Hemoglobinopathies, Thalassemia, Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention (Observational Study)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: No Intervention (Observational Study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Hemoglobinopathies.
Number of patients diagnosed with each hemoglobinopathy type (e.g., β-thalassemia trait, sickle cell disease, HbE).
Measured: At the time of diagnosis / Single assessment at enrollment
Secondary outcomes (1)
Demographic Distribution of Hemoglobinopathies by Age, Gender, and Geographic Area
The study analyzes the demographic characteristics of patients diagnosed with hemoglobinopathies, including distribution by age groups, gender, and geographic location (Mardan and surrounding districts). This outcome helps to identify patterns of disease occurrence and risk groups within the population. Data are derived from patient records and laboratory-confirmed cases.
Measured: At the time of diagnosis / Single assessment at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start15 Jan 2021
- Primary completion15 Jan 2023
- Study completion20 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemoglobinopathiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 839 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bacha Khan Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Malik Shayan Ali Khan, Bacha Khan Medical College
- Investigators
- Malik Shayan Ali Khan, MBBS, Principal investigator, Bacha Khan Medical College, Mardan.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07180836
- Sponsor's protocol ID
- Ref no. 499/BKMC
- Status last verified
- Aug 2025
- First submitted
- 30 Aug 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Hematological Characteristics of Hemoglobinopathies: A Cross-Sectional Study From a Tertiary Care Hospital
- ClinicalTrials.gov ID
- NCT07180836
- Acronym / sponsor ID
- Ref no. 499/BKMC
- Conditions
- Hemoglobinopathies
- Keywords
- Hemoglobinopathies, Thalassemia, Sickle cell disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 839 participants (actual)
- Lead sponsor
- Bacha Khan Medical CollegeUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Hemoglobinopathies are among the most common inherited disorders worldwide, caused by mutations in globin genes affecting hemoglobin synthesis, structure, and function. They are highly prevalent in South Asia, particularly in Pakistan, where beta-thalassemia is the most frequent single-gene disorder. Despite this, there is limited epidemiological data from Khyber Pakhtunkhwa (KPK), especially in Mardan, where consanguineous marriages are common and contribute to disease burden.
This descriptive cross-sectional study was conducted over a two-year period (January 2021 to January 2023) at the hematology department of Mardan Medical Complex, Pakistan. All patients referred for hemoglobinopathy testing were included. Blood samples (3 mL EDTA) were collected and analyzed for complete blood counts (hemoglobin, RBC count, hematocrit, MCV, MCH, MCHC) using Sysmex XN1000, and hemoglobin variants were identified using High Performance Liquid Chromatography (Bio-Rad D-10 analyzer). A sickling test was performed in cases with abnormal S-window chromatogram findings.
A total of 839 participants were analyzed. Geographic distribution was showed for patients from different nearby regions .
This study provides the first comprehensive regional overview of hemoglobinopathies in Mardan, KPK. The findings of our study will emphasize the need for early detection, genetic counseling, and preventive public health strategies, particularly in communities with high rates of consanguinity. These results might support the development of targeted screening and awareness programs to reduce the burden of hemoglobinopathies in Pakistan.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Hemoglobinopathies in Mardan and Surrounding Districts | – | Other: No Intervention (Observational Study)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 |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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%).
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention (Observational Study)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. | Other | Patients with Hemoglobinopathies in Mardan and Surrounding Districts |
Primary outcome
Prevalence of Hemoglobinopathies.
Time frame: At the time of diagnosis / Single assessment at enrollment
Number of patients diagnosed with each hemoglobinopathy type (e.g., β-thalassemia trait, sickle cell disease, HbE).
1 secondary outcome
Demographic Distribution of Hemoglobinopathies by Age, Gender, and Geographic Area
Time frame: At the time of diagnosis / Single assessment at enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
Related trials for Hemoglobinopathies
Active, not recruitingPhase 1/2
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Long-term Mitapivat Dosing in Subjects With Stable Sickle Cell Disease: An Extension of a Phase I Pilot Study of Mitapivat
Sickle Cell Disease, Hemolytic Anemia
RecruitingObservational study
HPC Offered for PRESERVE Expansion
Bone Marrow Transplant (BMT)
RecruitingPhase 1
Study to Evaluate the Safety and Tolerability of Escalating Doses of Fostamatinib in Subjects With Stable Sickle Cell Disease
Sickle Cell Disorders, Sickle Cell Disease
RecruitingPhase 4
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
Sickle Cell Disease (SCD), Vaso-Occlusive Pain Episode in Sickle Cell Disease
Active, not recruiting
Evaluation the Safety and Efficacy of KL003 Cell Injection in the Treatment of Transfusion-dependent β-thalassemia.
Transfusion-dependent Beta-Thalassemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malik Shayan Ali Khan, MBBS principal investigator
Bacha Khan Medical College, Mardan.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemoglobinopathies, run by Bacha Khan Medical College at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Hemoglobinopathies. (time frame: At the time of diagnosis / Single assessment at enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.