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Recruitment status
Unique ID issued by UMIN UMIN000000691
Receipt No. R000000829
Scientific Title The Study on Appropriate Strategy of Transfusion in Cardiovascular Surgery: a multicenter randomized controlled trial.
Date of disclosure of the study information 2007/05/01
Last modified on 2007/04/26

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Basic information
Public title The Study on Appropriate Strategy of Transfusion in Cardiovascular Surgery: a multicenter randomized controlled trial.
Acronym ASTRACS Study
Scientific Title The Study on Appropriate Strategy of Transfusion in Cardiovascular Surgery: a multicenter randomized controlled trial.
Scientific Title:Acronym ASTRACS Study
Region
Japan

Condition
Condition Patients who undergo thoracic aortic surgery
Classification by specialty
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of ASTRACS study is to assess the impact of two different strategy of blood transfusion on bleeding and the total volume of red blood cell transfusion requirements during and after thoracic aortic surgery
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II,III

Assessment
Primary outcomes Main outcome measures: The total volume of allogeneic red blood cells transfused during the surgery and within 24 hours after the surgery
Key secondary outcomes Other outcome measures: The total volume of mediastinal drainage during the first 12 hours or the first 24 hours in the ICU, re-exploration for bleeding, duration of time in the operating room after CPB, length of stay in ICU and hospital, hospital death, one-year survival, morbidity (e.g., renal failure, liver dysfunction, infection, heart failure, MI, neurological dysfunction, thromboembolic events), the total amount of each blood component transfused during hospitalization, the value of hemoglobin, platelet count, fibrinogen, prothrombin time, or activated partial thromboplastin time just prior to transfusion of each blood component, and the total medical cost.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Arm1: liberal strategy
Platelet concentrates are transfused if the platelet count drops below 100,000/uL,and platelet counts are maintained at 100,000/uLor more.
Cryoprecipitates are transfused if plasma fibrinogen level drops below 150 mg/dL, and plasma fibrinogen levels are maintained at 150 mg/dL or more.
Interventions/Control_2 Arm2: restrictive strategy
Platelet concentrates are transfused if the platelet count drops below 50,000/uL,and platelet counts are maintained at 50,000/uLor more.
Fresh frozen plasmas are transfused if plasma fibrinogen level drops below 150 mg/dL, and plasma fibrinogen levels are maintained at 150 mg/dL or more.
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
20 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Patient must be scheduled to undergo thoracic aortic surgery
Patient must be >=20 years and <90 years of age
Patient must be willing and able to give informed consent
(or written informed consent is obtained from the patient's legal representative in case in which informed consent could not be obtained from the patient because of critical illness.)
Key exclusion criteria The Patient has a congenital bleeding tendency
The patient has chronic thrombocytopenia (defined as a platelet count <100,000/uL for more than 30 days)
The patient has anemia (defined as a hemoglobin level <8.0g/dL)
The patient possesses an anti-HLA or anti-platelet antibody, resulting in platelet refractoriness
It is highly possible to complete the surgery of the patient without any transfusion in the judgement of the investigator.
The patient is inappropriate for entry onto this study in the judgment of the investigator.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hitoshi Ogino
Organization National Cardiovascular Center
Division name Department of Cardiovascular Surgery
Zip code
Address 5-7-1 Fujishiro-dai, Suita, Osaka, Japan
TEL 06-6833-5012
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hitoshi Ogino
Organization National Cardiovascular Center
Division name Department of Cardiovascular Surgery
Zip code
Address 5-7-1 Fujishiro-dai, Suita, Osaka, Japan
TEL 06-6833-5012
Homepage URL
Email hogino@hsp.ncvc.go.jp

Sponsor
Institute National Cardiovascular Center
Institute
Department

Funding Source
Organization Japanese Ministry of Health, Labor, and Welfar
Organization
Division
Category of Funding Organization
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

Other administrative information
Date of disclosure of the study information
2007 Year 05 Month 01 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
Date of protocol fixation
2007 Year 01 Month 15 Day
Date of IRB
Anticipated trial start date
2007 Year 04 Month 01 Day
Last follow-up date
2009 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2007 Year 04 Month 26 Day
Last modified on
2007 Year 04 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000829

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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