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Trial registered on ANZCTR


Registration number
ACTRN12612001063808
Ethics application status
Approved
Date submitted
3/10/2012
Date registered
4/10/2012
Date last updated
15/10/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigation of the effect of cryoprecipitate (blood plasma product that can help blood to clot) transfusion on coagulation abnormalities after open heart, aortic surgeries
Scientific title
Fibrinogen recovery and FIBTEM changes after cryoprecipitate transfusion in patients undergoing aortic surgery involving deep hypothermic circulatory arrest
Secondary ID [1] 281347 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
patients undergoing elective or emergency aortic surgery involving deep hypothermic circulatory arrest (DHCA) during cardiopulmonary bypass (CPB) 287563 0
Condition category
Condition code
Anaesthesiology 287888 287888 0 0
Other anaesthesiology
Blood 287889 287889 0 0
Clotting disorders
Surgery 287892 287892 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. If considered appropriate clinically and with laboratory (FIBTEM A10 result), 10 units of cryoprecipitate (350-400ml /10 units) are transfused 5-10 minutes after protamine administration at the end of cardiopulmonary bypass (CPB) weaning.
2. 10 units of cryoprecipitates are given over 20-30 minutes.
3. 10 minutes after completion of cryoprecipitate transfusion, the following test are done.
- platelet count, PT, INR, aPTT, fibrinogen
- ROTEM parameters : coagulation time (CT), alpha angle, clot amplitude A10 (amplitude at 10 minutes after clotting initiation) in extrinsically-activated EXTEM and fibrin-based FIBTEM
Intervention code [1] 285802 0
Treatment: Other
Comparator / control treatment
This study is a single group trial.
This study is to see the effect of cryoprecipitate transfusion, therefore compares before and after transfusion.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288104 0
Changes in clot amplitude A10 (amplitude at 10 minutes after clotting initiation) in fibrin-based FIBTEM
Timepoint [1] 288104 0
10 minutes after cryoprecipitate transfusion
Secondary outcome [1] 299432 0
Changes in clotting time (CT) in extrinsically-activated EXTEM
Timepoint [1] 299432 0
10 minutes after cryoprecipitate transfusion
Secondary outcome [2] 299435 0
Changes in alpha angle in extrinsically-activated EXTEM
Timepoint [2] 299435 0
10 minutes after cryoprecipitate transfusion
Secondary outcome [3] 299436 0
Changes in clot amplitude A10 (amplitude at 10 minutes after clotting initiation) in extrinsically-activated EXTEM
Timepoint [3] 299436 0
10 minutes after cryoprecipitate transfusion

Eligibility
Key inclusion criteria
Elective or emergency aortic surgery involving deep hypothermic circulatory arrest (DHCA) during cardiopulmonary bypass (CPB)
Minimum age
20 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients were excluded from the study if they revealed severe hypofibrinogenemia preoperatively, indicated by serum fibrinogen < 50mg/dl or FIBTEM < 1, or if the patients were not indicated to receive cryoprecipitate transfusion after protamine reversal.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4582 0
Korea, Republic Of
State/province [1] 4582 0
Seoul

Funding & Sponsors
Funding source category [1] 286104 0
Hospital
Name [1] 286104 0
Samsung Medical Center Clinical Research Development Program
Address [1] 286104 0
50 Ilwon Dong, Gangnam gu, 135-710
Samsung Medical Center
Country [1] 286104 0
Korea, Republic Of
Primary sponsor type
Hospital
Name
Samsung Medical Center Clinical Research Development Program
Address
50 Ilwon Dong, Gangnam gu, 135-710
Samsung Medical Center
Country
Korea, Republic Of
Secondary sponsor category [1] 284919 0
None
Name [1] 284919 0
Address [1] 284919 0
Country [1] 284919 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288150 0
Samsung Medical Center Istitutional review board
Ethics committee address [1] 288150 0
50 Ilwon Dong, Gangnam gu, 130-710
Samsung Medical Center
Ethics committee country [1] 288150 0
Korea, Republic Of
Date submitted for ethics approval [1] 288150 0
Approval date [1] 288150 0
21/10/2009
Ethics approval number [1] 288150 0

Summary
Brief summary
Cryoprecipitate may be used as haemostatic agent in patients with bleeding following on-pump aortic surgery with deep hypothermic circulatory arrest (DHCA). Its effect on plasma fibrinogen concentration and fibrin clot quality has not been reported to date. Standard coagulation laboratory and ROTEM parameters including clotting time (CT), alpha angle (a), clot amplitude A10 (amplitude at 10 minutes after clotting initiation) in extrinsically-activated EXTEM and fibrin-based FIBTEM were evaluated before and after cryoprecipitate transfusion.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34789 0
Address 34789 0
Country 34789 0
Phone 34789 0
Fax 34789 0
Email 34789 0
Contact person for public queries
Name 18036 0
Sang Hyun Lee
Address 18036 0
Ilwon Dong, Gangnam gu, 135-710
Samsung Medical Center
Country 18036 0
Korea, Republic Of
Phone 18036 0
+82-2-3410-2470
Fax 18036 0
Email 18036 0
joy2sarah@yahoo.co.kr
Contact person for scientific queries
Name 8964 0
Sang Hyun Lee
Address 8964 0
Ilwon Dong, Gangnam gu, 135-710
Samsung Medical Center
Country 8964 0
Korea, Republic Of
Phone 8964 0
+82-2-3410-2470
Fax 8964 0
Email 8964 0
joy2sarah@yahoo.co.kr

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary