UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000691 |
|---|---|
| Receipt number | 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 11:05:27 |
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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
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
hogino@hsp.ncvc.go.jp
Sponsor or person
Institute
National Cardiovascular Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000829
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