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Investigation of the effect of cryoprecipitate (blood plasma product that can help blood to clot) transfusion on coagulation abnormalities after open heart, aortic surgeries

Fibrinogen recovery and FIBTEM changes after cryoprecipitate transfusion in patients undergoing aortic surgery involving deep hypothermic circulatory arrest

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612001063808
Enrollment
10
Registered
2012-10-04
Start date
2009-12-27
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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,

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

Sponsors

Samsung Medical Center Clinical Research Development Program
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
20 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

Elective or emergency aortic surgery involving deep hypothermic circulatory arrest (DHCA) during cardiopulmonary bypass (CPB)

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026