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Clinical database registration of aplastic anemia patients

Clinical database registration of aplastic anemia patients

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045895
Enrollment
Unknown
Registered
2021-04-27
Start date
2020-11-01
Completion date
Unknown
Last updated
2021-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

aplastic anemia

Interventions

Non-transfusions independent non-severe aplastic anemia:ciclosporin
Transfusion dependent non - severe aplastic anemia:CsA combined with hematopoietic therapy
Severe aplastic anemia:Intensive immunosuppressive therapy
Severe aplastic anemia:Hematopoietic stem cell transplantation
Non-transfusions independent non-severe aplastic anemia:Promoting hematopoiesis therapy

Sponsors

Jiangsu Province Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. All enrolled patients were peripheral pancytopenia, according with two of the four items: the absolute value of neutrophil count (ANC) < 1.5x10^9/L, platelet (PLT) count < 100x10^9/L, hemoglobin (Hb) level < 100g/L, reduced absolute value of reticulocyte (Ret), meeting the AA diagnostic criteria; low myeloid hyperplasia was revealed through bone marrow smears and biopsy, and other disorders that could cause anemia were excluded, such as myelodysplastic syndrome (MDS) and paroxysmal nocturnal hemoglobinuria (PNH); 2. Men or women aged 18 to 75 years; 3. Patients were with a ECOG <= 2 points; 4. Patients were with a AST of < 2.0 times higher than the normal upper limit, ALT of < 2.0 times higher than the normal upper limit, total bilirubin of < 2.0times higher than the normal upper limit, and serum creatinine and urea of < 1.25 times higher than the normal upper limit; And no evidence of cardiac insufficiency; 5. Subjects were signed the informed consent, which indicated they understood the purpose, the procedure and potential benefits of the trial and were willing to participate in the trial.

Exclusion criteria

Exclusion criteria: 1. Patients suffered from congenital bone marrow failure disease, myeloproliferative neoplasms and so on; 2. Patients were with clonal hematopoiesis, such as myelodysplastic syndromes, acute myeloid leukemia, paroxysmal nocturnal hemoglobinuria, etc.; 3. Patients were with severe organ damages: respiratory failure, uncontrolled heart disease or congestive heart failure, decompensated liver insufficiency, renal insufficiency, etc.; 4. Patients were sero-positive for HIV; 5. Men or women developed autoimmune hemolytic anemia or immune thrombocytopenia; 6. Patients with mental disorders or other illnesses, were unable to fully comply with trial treatment or follow-up requirements.

Design outcomes

Primary

MeasureTime frame
Basic cure;Remission;Apparent improvement;Inefficiency;

Secondary

MeasureTime frame
Quality of life evaluation;Hospitalization;

Countries

China

Contacts

Public ContactHe Guangsheng

Jiangsu Province Hospital

heguangsheng1972@sina.com+86 15312052798

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 12, 2026