Blood DiseaseNCT00005682
Aplastic Anemia Epidemiology: Incidence and Case-control
An observational study of Blood Disease and Anemia, Aplastic, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To conduct incidence and case-control studies of aplastic anemia in metropolitan Bangkok, Thailand Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Blood Disease, Anemia, Aplastic
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1988to Aug 1994
- 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 Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To conduct incidence and case-control studies of aplastic anemia in metropolitan Bangkok, Thailand
Read the detailed description
BACKGROUND:
Aplastic anemia, a form of bone marrow failure, is a disease of largely unknown cause, except for the rare situations involving high doses of radiation. Many agents have been mentioned in case reports to be associated with the development of aplastic anemia and include drugs, chemicals, pesticides, radiation, and viral infection. Of these, chloramphenicol, phenylbutazone, and insecticides are most frequently reported. In the United States and other developed countries the disease prevalence is so low that too few cases occur to make an epidemiological study in a single city logistically feasible. The Bangkok hospitalization rate for aplastic anemia was sufficient to conduct a case-control study. Also, a study conducted in this locale provided information on drugs and chemicals not commonly used in developed countries.
DESIGN NARRATIVE:
All aplastic anemia cases in metropolitan Bangkok were located and verified in the forty hospitals that agreed to participate in the study. Incidence rates were calculated by age group and sex. In the case-control study, interviews were used to obtain comprehensive histories of drug, chemical, pesticide, radiation, viral infections, and other exposures, along with relevant demographic and medical history information in order to examine the association between and test hypotheses regarding suspected hazards and to estimate the risks of developing aplastic anemia. The basic epidemiologic features of aplastic anemia were described by characterizing these patients in terms of standard demographic variables, age, race, sex, and medical history. The degree of association between viral hepatitis and the development of aplastic anemia was estimated.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Conditions
- Blood Disease, Anemia, Aplastic
- Medical subject headings
- Hematologic Diseases, Anemia, Aplastic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startSep 1988
- Study completionAug 1994
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Blood DiseaseStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- 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
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Paul LeavertonSamuel Shapiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005682
- Sponsor's protocol ID
- 3008
- Other IDs
- R01HL035068
- Status last verified
- May 2000
- First submitted
- 25 May 2000
- Last updated
- 18 Feb 2016
- Results posted
- No
Publications
Issaragrisil S, Kaufman DW, Anderson TE, Chansung K, Thamprasit T, Sirijirachai J, Piankijagum A, Porapakham Y, Vannasaeng S, Leaverton PE, et al. An association of aplastic anaemia in Thailand with low socioeconomic status. Aplastic Anemia Study Group. Br J Haematol. 1995 Sep;91(1):80-4. doi: 10.1111/j.1365-2141.1995.tb05248.x.
PubMed 7577657Hibbs JR, Issaragrisil S, Young NS. High prevalence of hepatitis C viremia among aplastic anemia patients and controls from Thailand. Am J Trop Med Hyg. 1992 May;46(5):564-70. doi: 10.4269/ajtmh.1992.46.564.
PubMed 1318006Issaragrisil S, Sriratanasatavorn C, Piankijagum A, Vannasaeng S, Porapakkham Y, Leaverton PE, Kaufman DW, Anderson TE, Shapiro S, Young NS. Incidence of aplastic anemia in Bangkok. The Aplastic Anemia Study Group. Blood. 1991 May 15;77(10):2166-8.
PubMed 2029577Kaufman DW, Issaragrisil S, Anderson T, Chansung K, Thamprasit T, Sirijirachai J, Piankijagum A, Porapakkham Y, Vannasaeng S, Leaverton PE, Shapiro S, Young NS. Use of household pesticides and the risk of aplastic anaemia in Thailand. The Aplastic Anemia Study Group. Int J Epidemiol. 1997 Jun;26(3):643-50. doi: 10.1093/ije/26.3.643.
PubMed 9222791Issaragrisil S, Kaufman DW, Anderson T, Chansung K, Thamprasit T, Sirijirachai J, Piankijagum A, Porapakkham Y, Vannasaeng S, Leaverton PE, Shapiro S, Young NS. Low drug attributability of aplastic anemia in Thailand. The Aplastic Anemia Study Group. Blood. 1997 Jun 1;89(11):4034-9.
PubMed 9166842Issaragrisil S, Kaufman D, Thongput A, Chansung K, Thamprasit T, Piankijagum A, Anderson T, Shapiro S, Leaverton P, Young NS. Association of seropositivity for hepatitis viruses and aplastic anemia in Thailand. Hepatology. 1997 May;25(5):1255-7. doi: 10.1002/hep.510250532.
PubMed 9141447Issaragrisil S, Kaufman DW, Anderson T. Incidence and non-drug aetiologies of aplastic anaemia in Thailand. The Thai Aplastic Anaemia Study Group. Eur J Haematol Suppl. 1996;60:31-4. doi: 10.1111/j.1600-0609.1996.tb01642.x.
PubMed 8987238
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aplastic Anemia Epidemiology: Incidence and Case-control
- ClinicalTrials.gov ID
- NCT00005682
- Acronym / sponsor ID
- 3008
- Conditions
- Blood Disease, Anemia, Aplastic
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 1988
- Study completion
- Aug 1994 (actual)
- First posted
- 26 May 2000 (estimated)
- 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.
To conduct incidence and case-control studies of aplastic anemia in metropolitan Bangkok, Thailand
Detailed description
BACKGROUND:
Aplastic anemia, a form of bone marrow failure, is a disease of largely unknown cause, except for the rare situations involving high doses of radiation. Many agents have been mentioned in case reports to be associated with the development of aplastic anemia and include drugs, chemicals, pesticides, radiation, and viral infection. Of these, chloramphenicol, phenylbutazone, and insecticides are most frequently reported. In the United States and other developed countries the disease prevalence is so low that too few cases occur to make an epidemiological study in a single city logistically feasible. The Bangkok hospitalization rate for aplastic anemia was sufficient to conduct a case-control study. Also, a study conducted in this locale provided information on drugs and chemicals not commonly used in developed countries.
DESIGN NARRATIVE:
All aplastic anemia cases in metropolitan Bangkok were located and verified in the forty hospitals that agreed to participate in the study. Incidence rates were calculated by age group and sex. In the case-control study, interviews were used to obtain comprehensive histories of drug, chemical, pesticide, radiation, viral infections, and other exposures, along with relevant demographic and medical history information in order to examine the association between and test hypotheses regarding suspected hazards and to estimate the risks of developing aplastic anemia. The basic epidemiologic features of aplastic anemia were described by characterizing these patients in terms of standard demographic variables, age, race, sex, and medical history. The degree of association between viral hepatitis and the development of aplastic anemia was estimated.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 Feb 2016.
- Background: PubMed 7577657Issaragrisil S, Kaufman DW, Anderson TE, Chansung K, Thamprasit T, Sirijirachai J, Piankijagum A, Porapakham Y, Vannasaeng S, Leaverton PE, et al. An association of aplastic anaemia in Thailand with low socioeconomic status. Aplastic Anemia Study Group. Br J Haematol. 1995 Sep;91(1):80-4. doi: 10.1111/j.1365-2141.1995.tb05248.x.
- Background: PubMed 1318006Hibbs JR, Issaragrisil S, Young NS. High prevalence of hepatitis C viremia among aplastic anemia patients and controls from Thailand. Am J Trop Med Hyg. 1992 May;46(5):564-70. doi: 10.4269/ajtmh.1992.46.564.
- Background: PubMed 2029577Issaragrisil S, Sriratanasatavorn C, Piankijagum A, Vannasaeng S, Porapakkham Y, Leaverton PE, Kaufman DW, Anderson TE, Shapiro S, Young NS. Incidence of aplastic anemia in Bangkok. The Aplastic Anemia Study Group. Blood. 1991 May 15;77(10):2166-8.
- Background: PubMed 9222791Kaufman DW, Issaragrisil S, Anderson T, Chansung K, Thamprasit T, Sirijirachai J, Piankijagum A, Porapakkham Y, Vannasaeng S, Leaverton PE, Shapiro S, Young NS. Use of household pesticides and the risk of aplastic anaemia in Thailand. The Aplastic Anemia Study Group. Int J Epidemiol. 1997 Jun;26(3):643-50. doi: 10.1093/ije/26.3.643.
- Background: PubMed 9166842Issaragrisil S, Kaufman DW, Anderson T, Chansung K, Thamprasit T, Sirijirachai J, Piankijagum A, Porapakkham Y, Vannasaeng S, Leaverton PE, Shapiro S, Young NS. Low drug attributability of aplastic anemia in Thailand. The Aplastic Anemia Study Group. Blood. 1997 Jun 1;89(11):4034-9.
- Background: PubMed 9141447Issaragrisil S, Kaufman D, Thongput A, Chansung K, Thamprasit T, Piankijagum A, Anderson T, Shapiro S, Leaverton P, Young NS. Association of seropositivity for hepatitis viruses and aplastic anemia in Thailand. Hepatology. 1997 May;25(5):1255-7. doi: 10.1002/hep.510250532.
- Background: PubMed 8987238Issaragrisil S, Kaufman DW, Anderson T. Incidence and non-drug aetiologies of aplastic anaemia in Thailand. The Thai Aplastic Anaemia Study Group. Eur J Haematol Suppl. 1996;60:31-4. doi: 10.1111/j.1600-0609.1996.tb01642.x.
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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.
Paul Leaverton
Samuel Shapiro
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Disease and Anemia, Aplastic, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005682, which also lists 7 linked publications.
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 Feb 2016; AzTrials last refreshed its copy on 1 Nov 2026.