UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017938 |
|---|---|
| Receipt number | R000020778 |
| Scientific Title | Clinical trial of a blood purification system, HAYATE, on conciousness-recovery effect in patients with acute liver failure with hepatic coma |
| Date of disclosure of the study information | 2015/06/17 |
| Last modified on | 2018/06/20 17:05:37 |
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Basic information
Public title
Clinical trial of a blood purification system, HAYATE, on conciousness-recovery effect in patients with acute liver failure with hepatic coma
Acronym
Clinical trial of HAYATE on conciousness-recovery effect from hepatic coma
Scientific Title
Clinical trial of a blood purification system, HAYATE, on conciousness-recovery effect in patients with acute liver failure with hepatic coma
Scientific Title:Acronym
Clinical trial of HAYATE on conciousness-recovery effect from hepatic coma
Region
| Japan |
Condition
Condition
acute liver failure with hepatic coma and late onset hepatic failure
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of consciousness-recovery effect of the newly developed blood purifying device, HAYATE, in patients with acute liver failure with hepatic coma.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Consciousness-recovery rate within 10 days
Key secondary outcomes
Change in serum ammonia level
Change in blood glutamine level
Change in serum TNF-alpha, IL-6, and IL-1beta levels
Period to consciousness recovery
Bridge to liver transplantation
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
On-line continuous hemodiafiltration using HAYATE
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients with acute liver failure with hepatic coma and late onset hepatic failure according to the diagnosiitc criteria in Japan.
(2) A written informed consent from the patient or representative is necessary.
Key exclusion criteria
(1) Child or elderly person who is intolerable to extracorporeal circulation
(2) Patient with overt brain edema
(3) Patient with liver malignancy
(4) Hyperacute-type liver failure
(5) Patient whose conscious level can't be evaluated
(6) Patient who is intolerable to extracorporeal circulation because of unstable hemodynamics
(7) Inadequate condition as considered by primary physician
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Takikawa |
Organization
Iwate Medical University
Division name
Division of Hepatology, Internal Medicine
Zip code
Address
19-1 Uchimaru, Morioka, Japan
TEL
+81-19-651-5111
ytakikaw@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Sasaki |
Organization
Iwate Medical University
Division name
Liaison center office
Zip code
Address
19-1 Uchimaru, Morioka, Japan
TEL
+81-19-651-5111
Homepage URL
kenji.sasaki@j.iwate-med.ac.jp
Sponsor or person
Institute
Iwate Medical University
Institute
Department
Personal name
Funding Source
Organization
Asahi Kasei Medical Co. Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Seven out of 8 (87.5%) patients regained consciousness during the on-line CHDF session, with 5 of those 7 waking within 4 days, while the others awoke on days 6 and 10. After waking, one patient spontaneously recovered, three received LT, two died of liver failure and one died of another disease. The plasma ammonia levels constantly and significantly decreased after the start of on-line CHDF from 182.5 +- 64.8 ug/dL (mean +- s.d.) at day 0 to 110.3 +- 48.0 ug/dL (p=0.0026) at day 3 and 87.0 +- 38.9 ug/dL at the last day of the session (p<0.001). Similarly, the plasma glutamine level also significantly decreased from 2069 +- 1234 umol/L at day 0 to 628 +- 193 umol/L at the last day. Although seven severe adverse events occurred during the ALS, including pneumonia, sepsis, disseminated intravascular coagulation, syncope, brain edema, ARDS and enteritis, no causal relationship to the ALS was recognized because of other apparent causes. Conclusions: Our newly-developed on-line CHDF ALS system showed extremely high efficacy for helping patients regain consciousness and excellent safety as therapy for ALF.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 03 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 02 | Day |
Last follow-up date
Date of closure to data entry
| 2017 | Year | 03 | Month | 08 | Day |
Date trial data considered complete
| 2017 | Year | 07 | Month | 13 | Day |
Date analysis concluded
| 2017 | Year | 09 | Month | 12 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 17 | Day |
Last modified on
| 2018 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020778
