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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017938
Receipt No. 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

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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
Email 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
Email kenji.sasaki@j.iwate-med.ac.jp

Sponsor
Institute Iwate Medical University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020778

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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