Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04502628
Status:
RECRUITING
Last Update Posted:
2021-09-08
First Post:
2020-07-30
Brief Title:
Hyperbaric Oxygen Therapy for Hemorrhagic Cystitis Post HSCT
Sponsor:
Shandong Provincial Hospital
Organization:
Shandong Provincial Hospital
Study Overview
Official Title:
Hyperbaric Oxygen Therapy for the Treatment of Hemorrhagic Cystitis Post Allogeneic Hematopoietic Stem Cell Transplantation
Status:
RECRUITING
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Allogeneic hematopoietic stem cell transplantation allo-HSCT is a potentially curative therapy for many malignant or nonmalignant hematological diseases Hemorrhagic cystitis HC is one of the common and major causes of morbidity in patients undergoing allo-HSCT Its incidence ranges from 7 to 52 and its manifestations range from painless microscopic hematuria to severe bladder hemorrhage leading to clot formation within the urinary tract and even renal failure This complication results in much pain to the patient and increasing treatment cost
Late-onset HC two weeks after stem cell infusion has been associated with reactivation of viruses including cytomegalovirus polyoma BK and JC viruses and adenovirus types I and II Former studies have confirmed that the bladder is also considered to be one of the immune attacked organs in acute graft-versus-host disease aGVHD The classic treatments for HC include hydration alkalization and bladder irrigation immunosuppressant reduction and platelet transfusion Patients with viral infection may be treated with antiviral agents but their efficacy is limited When the HC was considered to be associated with aGVHD some immunosuppressive agents such as glucocorticoids will be added in However too intensive immunosuppressive measures leave the patients susceptible to infection and in turn increases the accidence of non-relapse mortality NRM The mechanism underlying the development of HC remains largely unidentified and its optimal treatment has not yet been established It is important to explore novel less-toxic higher effective and cost-effective strategies to improve HC
The elevated levels of available oxygen and partial pressure of arterial oxygen provide the main benefits of Hyperbaric oxygen therapy HBOT in clinical practice that addresses these areas of inadequate or poor tissue healing HBOT is utilized as primary or adjunctive therapy for many medical conditions in which tissue damage is triggered by hypoxic injury The pharmacological and physiologic effects of HBOT have direct and indirect mechanisms and effects on reactive oxygen species ROS most beneficial to that of wound healing and antibacterial treatments HBOT can stimulate fibroblast proliferation angiogenesis and wound healing It has been shown effective in the treatment of radiation-induced HC by promoting fibroblast proliferation and capillary angiogenesis decreasing edema and facilitating damaged hypoxic urothelium Based on the above clinical and pre-clinical practice the investigators deduce that HBOT may benefit patients with HC after HSCT In the investigators limited early-onset investigation the investigators found HBO was largely successful in 20 patients suffering HC post-allo-HSCT showed a quick resolution or improvement of HC The investigators also observed more rapid responses in patients who started HBOT earlier after the diagnosis of HC The investigators confirmed that HBOT was effective and well-tolerated in the patients regardless of the infective- or non-infective- caused HC Therefore the investigators design this prospective randomized and single-arm clinical trial to establish the definitive efficacy and safety of HBOT in patients with HC after allo-HSCT
Late-onset HC two weeks after stem cell infusion has been associated with reactivation of viruses including cytomegalovirus polyoma BK and JC viruses and adenovirus types I and II Former studies have confirmed that the bladder is also considered to be one of the immune attacked organs in acute graft-versus-host disease aGVHD The classic treatments for HC include hydration alkalization and bladder irrigation immunosuppressant reduction and platelet transfusion Patients with viral infection may be treated with antiviral agents but their efficacy is limited When the HC was considered to be associated with aGVHD some immunosuppressive agents such as glucocorticoids will be added in However too intensive immunosuppressive measures leave the patients susceptible to infection and in turn increases the accidence of non-relapse mortality NRM The mechanism underlying the development of HC remains largely unidentified and its optimal treatment has not yet been established It is important to explore novel less-toxic higher effective and cost-effective strategies to improve HC
The elevated levels of available oxygen and partial pressure of arterial oxygen provide the main benefits of Hyperbaric oxygen therapy HBOT in clinical practice that addresses these areas of inadequate or poor tissue healing HBOT is utilized as primary or adjunctive therapy for many medical conditions in which tissue damage is triggered by hypoxic injury The pharmacological and physiologic effects of HBOT have direct and indirect mechanisms and effects on reactive oxygen species ROS most beneficial to that of wound healing and antibacterial treatments HBOT can stimulate fibroblast proliferation angiogenesis and wound healing It has been shown effective in the treatment of radiation-induced HC by promoting fibroblast proliferation and capillary angiogenesis decreasing edema and facilitating damaged hypoxic urothelium Based on the above clinical and pre-clinical practice the investigators deduce that HBOT may benefit patients with HC after HSCT In the investigators limited early-onset investigation the investigators found HBO was largely successful in 20 patients suffering HC post-allo-HSCT showed a quick resolution or improvement of HC The investigators also observed more rapid responses in patients who started HBOT earlier after the diagnosis of HC The investigators confirmed that HBOT was effective and well-tolerated in the patients regardless of the infective- or non-infective- caused HC Therefore the investigators design this prospective randomized and single-arm clinical trial to establish the definitive efficacy and safety of HBOT in patients with HC after allo-HSCT
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None