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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007509
Receipt No. R000008863
Scientific Title Early versus Minimally-Invasive Goal-Directed Therapy on Delayed Cerebral Ischemia and Outcome after Subarachnoid Hemorrhage
Date of disclosure of the study information 2012/03/15
Last modified on 2018/09/06

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Basic information
Public title Early versus Minimally-Invasive Goal-Directed Therapy on Delayed Cerebral Ischemia and Outcome after Subarachnoid Hemorrhage
Acronym Early vs. Miminally-Invasive Goal-Directed Therapy and SAH Outcome
Scientific Title Early versus Minimally-Invasive Goal-Directed Therapy on Delayed Cerebral Ischemia and Outcome after Subarachnoid Hemorrhage
Scientific Title:Acronym Early vs. Miminally-Invasive Goal-Directed Therapy and SAH Outcome
Region
Japan

Condition
Condition Subarachnoid hemorrhage
Classification by specialty
Neurosurgery Intensive care medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Goal-directed fluid therapy based on cardiac output (CO) and intravascular volume is of paramount importance for preventing delayed cerebral ischemia (DCI) and improving outcome after subarachnoid hemorrhage (SAH), but questions regarding the timing of intensive management and method of monitoring still unresolved.
Basic objectives2 Others
Basic objectives -Others We aimed to determine the effectiveness of early-intensive or minimally-invasive hemodynamic management guided with advanced monitoring (transpumonary thermodilution [PiCCO], uncalibrated arterial pulse contour analysis [FloTrac], and non-invasive electrical velocimetry [Aesculon]) on DCI and outcomes after SAH, compared with conventional management using a pulmonary artery(Swan-Ganz) catheter.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Occurrence of clinical deterioration caused by DCI. Favorable outcome, defined as the proportion of patients with a modified Rankin score of 0 to 3.
Key secondary outcomes Ischemic lesion was assessed by cerebral blood flow using SPECT combined with 3D-SSP analysis (days 7 and 14) and MR diffusion weighted images (days 14 and 21). Occurrences of cardiopulmonary complications, daily fluid intake/loss, and fluid balance calculated daily by subtracting urinary volume from total oral and intravenous intake. Fluid responsiveness using stroke volume variation, central venous pressure or pulmonary artery wedge pressure. Reliability of cardiac output and stroke volume among monitoring devices was also assessed.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Early-intensive group, day 0 to 14 after SAH onset
Interventions/Control_2 Minimally-invasive group, day 0 to 14 after SAH onset
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
30 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria Patients were eligible if they were treated with surgical clipping or endovascular coiling for aneurysm.
Key exclusion criteria Exclusion criteria were 1) both good grade (World Federation of Neurological Surgery [WFNS] grade I) and modest bleeds (Fisher CT grade<2), 2) renal disease (creatinine level >2.0 mg/dl) that may limit appropriate fluid loading for volume therapy, and 3) severe left ventricular dysfunction (ejection fraction <35%), intracardiac shunt, permanent cardiac arrhythmia, significant valvular heart disease, or occlusive peripheral arterial disease that may cause inaccurate CO analysis or may restrict hyperdynamic therapy using inotropic pressors.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsushi Mutoh
Organization Research Institute for Brain and Blood Vessels-AKITA
Division name Department of Surgical Neurology
Zip code
Address 6-10 Senshu-Kubota-machi, Akita 010-0874, Japan
TEL 018-833-0115
Email tmutoh@tiara.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsushi Mutoh
Organization Research Institute for Brain and Blood Vessels-AKITA
Division name Department of Surgical Neurology
Zip code
Address 6-10 Senshu-Kubota-machi, Akita 010-0874, Japan
TEL 018-833-0115
Homepage URL
Email tmutoh@tiara.ocn.ne.jp

Sponsor
Institute Research Institute for Brain and Blood Vessels-AKITA
Institute
Department

Funding Source
Organization Akita prefecture
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization Japan

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 秋田県立脳血管研究センター、手稲渓仁会病院、社会保険(現JCHO)神戸中央病院

Other administrative information
Date of disclosure of the study information
2012 Year 03 Month 15 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
2005 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2005 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 03 Month 14 Day
Last modified on
2018 Year 09 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008863

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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