hemorrhagic cystitis after hematopoietic stem cell transplantation
Conditions
Interventions
experimental group:1) Hydration: equal input of glucose or saline for 24h
2) Alkalization: 5% sodium bicarbonate intravenous infusion, maintaining urine PH between 7-8
3) Antiviral therapy: patients with positive virus detection were given daily acyclovir and ganciclovir treatment with intravenous drip
4) Immunotherapy: human globulin, in
control group:No uc-msc treatment.
Sponsors
Anhui Provincial Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 4-65 years old male and female; 2. Patients receiving allogeneic hematopoietic stem cell transplantation; 3. Hemorrhagic cystitis occurred during or after hematopoietic reconstitution after hematopoietic stem cell transplantation, excluding hematuria caused by urinary bacteria infection or systemic blood diseases; 4. Diagnosed grade i-iv hemorrhagic cystitis according to clinical symptoms, signs and laboratory tests; 5. Invalid patients after 3 days of conventional treatment; 6. The subject or its guardian shall sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Hematuria caused by urinary bacteria infection or systemic blood diseases; 2. Patients with solid malignant tumors within the last 5 years or currently; 3. Patients who have received HSC transplantation to treat solid tumors; 4. The patient has alcohol or drug abuse within 6 months; 5. The patient has any underlying or currently medically certified psychiatric symptoms; 6. Patients with severe systemic or local infection of uncontrollable bacteria, fungi or viruses, especially pulmonary infection; Septicemia, persistent bacteremia or meningitis;Active tuberculosis, severe acute hepatitis, or other active infectious diseases (including hepatitis b, hepatitis a, hiv-positive patients); 7. Severe cardiac insufficiency, if left ventricular injection rate < 50%;Patients with right ventricular failure, arrhythmia and other dysfunction; 8. Uncontrolled hypertension or congestive heart failure that requires the use of nitrates for active angina, myocardial infarction or arrhythmia or heart failure that requires active treatment in the past 6 months; 9. Patients with pulmonary hypertension; 10. Patients with diffuse alveolar hemorrhage and other progressive lung diseases may need masks or other auxiliary machinery to maintain blood oxygen concentration;Hypoxemia, oxygen saturation < 90%; 11. Presence of restrictive or obstructive pulmonary disease or respiratory failure requiring ventilator support; 12. The patients with severe liver dysfunction, with the peak value of glutamic acid transaminase and total bilirubin above 3 times; 13. Severe hepatic venous occlusion or sinus obstruction; 14. Severe renal insufficiency, and creatinine is more than twice the normal maximum;Creatinine clearance rate < 30 mL/min; 15. Patients with known allergic conditions, such as those allergic to human blood albumin; 16. Pregnant women or patients who plan to become pregnant, and lactating patients; 17. Tatients who are participating in other clinical trials; 18. The researchers concluded that other reasons were not appropriate for the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of urination;The degree of blood in the urine;Pain rating; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of complete absence of symptoms associated with hemorrhagic cystitis;Time to improve symptoms associated with hemorrhagic cystitis;Adverse event; | — |
Countries
China
Contacts
Public ContactHuilan Liu
Anhui Provincial Hospital
Outcome results
None listed