The Prevalence and Severity of HCV Infection in Thalassemia Major and Thalassemia Intermedia in Siriraj Hospital

March 21, 2017 updated by: Mahidol University

The primary objective is to assess the prevalence and genotypes of HCV infection in thalassemia major and thalassemia intermediate patients who have received blood transfusion in the Department of Medicine, Faculty of Medicine Siriraj Hospital.

The secondary objective is to identify the effect of HCV infection as well as the risk factors of advanced liver disease and liver cirrhosis in these patients

The third objective is to identify the role of serum HA level and fibrotest in the prediction of cirrhosis in these patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study protocol

Data collection:

The eligible patients will be asked to participate in the study. After signing informed consent, the patients will be asked to complete questionnaire, all clinical and laboratory data of the patients will be retrieved from out-patient electronic or paper medical records, electronic laboratory results. The data will include the followings:

  1. Clinical data

    • Demographic information (age, gender, ethnicity, education, marital status)
    • Family history of liver disease
    • Current relevant medication
    • Weight, height and body mass index (BMI) at the time of enrollment
    • History of blood or blood product transfusion, last transfusion
    • History of alcohol consumption
    • History of active liver disease

  2. Laboratory data

    • Complete blood count
    • Iron study (serum ferritin, serum iron, total iron binding capacity and transferrin saturation)
    • Hemoglobin typing
    • HIV antibody status (only if available)
    • liver biochemistry including AST, ALT, albumin, globulin
    • Blood urea nitrogen, creatinine
    • HBsAg, Anti-HBsAb
    • Anti-HCV antibody
    • HCV RNA, HCV genotyping (only in patients with positive Anti-HCV)
    • Serum hyaluronic acid
    • Fibrotest

After data collection, all patients will receive blood test for serum hyaluronic acid. If the patients have incomplete laboratory data (except HIV antibody status), they will receive additional blood tests for missing data. All patients will be appointed for transient elastography. All the cost for the extra-investigation will be supported by the study.

Transient elastography (TE or Fibroscan):

TE will be used to evaluate liver fibrosis. TE will be performed in all patients by examiners who were blind to clinical, laboratory data. The right lobe of the liver was targeted through an intercostal space access while the patient was lying in the dorsal decubitus position with the right arm in maximal abduction. With the assistance of TE, a liver portion of at least 6-cm thickness, free of large vessels, was identified for examination. The rate of successful measurements was interpreted by the ratio between the number of those validated and total number of measurements. The results were expressed as a median value of the total measurements in kPa. Patients with ascites were excluded from the study due to the limitation of result interpretation.

Data Handling :

Data of each patient will be collected at the OPD, Division of Hematology and Division of Gastroenterology, Siriraj Hospital, Mahidol University, Bangkok, Thailand.

The study will be started after it is approved by the Ethics Committee ofSiriraj Hospital. Patients' identification number will be stored in a separate log book. Results will be reported at the aggregate level only, and individual-level data will never be released.

Sample Size and Statistical analysis Sample size The primary research question of this study is to assess the prevalence of HCV infection in thalassemia major and thalassemia intermediate patients who received prior blood transfusion. From the previous research conducted by Wanachiwanawin W, et al , we estimate that the prevalence of hepatitis C viral infection in thalassemia patient is 20 percent. The sample size is 246 samples according to the calculation with 95 % confident interval.

Statistical analysis

  1. The quantitative data, such as age, will be analyzed by mean and standard deviation or by mode and median (in the data that doesn't have normal distribution). The quantitative data, such as sex, will be analyzed by using percentage and 95% confident interval for the prevalence.
  2. In comparison between two groups, the quantitative data, such as liver fibrosis: positive or negative, will be compared by using t-test (normality) or Mann-Whitney U-test (non-normality) and the quantitative data will be analyzed by Chi-square test or Fisher's exact test. If the results show statistically significance (P-value <0.05) more than one value, the Logistic Regression Analysis will be performed and presented by odds ratio and 95% confidence interval.

Study Type

Observational

Enrollment (Actual)

158

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Faculty of Medicine Siriraj Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The participants are thalassemia patients who regularly visit Hematology Clinic, Department of Medicine, Faculty of Medicine Siriraj Hospital

Description

Inclusion Criteria:

  1. Previously diagnosed thalassemia major, for example homozygous beta thalassemia or beta thalassemia/hemoglobin E disease or thalassemia intermedia such as hemoglobin H disease or homozygous Hb CS
  2. Age equal to or more than 18 years
  3. Previous history of blood transfusion

Exclusion Criteria:

  1. Patients who have hepatocellular carcinoma, ascites or pregnancy will be excluded from the study due to the limitation of result interpretation.
  2. Unwilling to participate
  3. Patient who receiving or completed treatment of hepatitis C

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study group
Population : The participants are thalassemia patients who regularly visit Hematology Clinic, Department of Medicine, Faculty of Medicine Siriraj Hospital Clinical data, Laboratory data (Blood samples) and Transient elastography data will be collected from all participants, as previously described.
Other: Transient elastography
Transient elastography (TE) is an ultrasound-based device used for measuring the degree of liver stiffness. A transducer probe is used to create mild amplitude and low frequency vibrations (50 Hz) that transmitted through the liver tissue. This results in an elastic shear wave that propagates through the underlying liver tissue. The probe then utilizes pulse-echo ultrasound to follow the propagation of the shear wave and to measure its velocity. The velocity of the wave is directly related to tissue stiffness which correlates with fibrosis. The sensitivity and the specificity of TE is between 68%-88% and between 66%-100%, respectively for the detection of significant liver fibrosis (METAVIR score F>2).
Other Names:
  • Fibroscan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence and genotypes of HCV infection in thalassemia major and thalassemia intermediate patients who have received blood transfusion in the Department of Medicine, Faculty of Medicine Siriraj Hospital
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Effect of HCV infection and the risk factors of advanced liver disease and liver cirrhosis in thalassemia major and thalassemia intermediate patients who have received blood transfusion
Time Frame: 1 year
1 year
Role of serum HA level and fibrotest in the prediction of cirrhosis in thalassemia major and thalassemia intermediate patients who have received blood transfusion in the Department of Medicine, Faculty of Medicine Siriraj Hospital.
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Tawesak Tanwandee, Assoc.Prof., Division of Gastroenterology, Faculty of Medicine, Siriraj hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

October 31, 2016

Study Completion (Actual)

October 31, 2016

Study Registration Dates

First Submitted

September 13, 2016

First Submitted That Met QC Criteria

September 13, 2016

First Posted (Estimate)

September 16, 2016

Study Record Updates

Last Update Posted (Actual)

March 23, 2017

Last Update Submitted That Met QC Criteria

March 21, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 481/2558

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Due to patients confidentiality in study protocol. The individual level data will not be released.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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