Yonsei Univ. dept. of Anesthesiology and pain medicine
Seoul, 120-752, South Korea
Completed
NCT Number: NCT01644084
A Comparison Between 5% Albumin and 6% Hydroxyethyl Starch 130/0.4 in Priming Solution for Cardiopulmonary Bypass and Post-bypass Maintenance Fluid in High-risk Patients
It is advantageous to use 5% human albumin (HA) in patients undergoing cardiopulmonary bypass (CPB), because preexposure of the synthetic surfaces of the CPB circuit to albumin decreases coagulopathy, platelet aggregation, immune responses. However the use of albumin is limited, because it is expensive and can rarely cause infection.
Hydroxyethyl starch (HES) decreases clot strength and prolong clot formation. A recently developed 6% HES 130/0.4 is known to have fewer effects on hemostasis. However Schramlo AA et al. reported that short time infusion of HES 130/0.4 after cardiac surgery produced impairment in fibrin formation and clot strength in thromboelastometry tracings.
Coagulopathy is directly related to bleeding and massive postoperative bleeding increases the risk of reoperation. Therefore it is important to avoid administration of fluids that can inhibit homeostasis after CPB.
The purpose of this study is to investigate the effect of 6% HES 130/0.4 as a component of priming solution on coagulation compared to 5% HA.
Completed
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Notify MeKey information
Age range
20 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- patients who have uncontrolled medical problems, life-threatening cardiac disease, complex cardiac surgery, or emergency operation
Exclusion criteria
- patients who had received warfarin, heparin, acetylsalicylic acid, or antiplatelet drug within 5 days before surgery
Treatment and study plan
Hydroxyethyl starch 130/0.4
DrugHydroxyethyl starch 130/0.4 as a priming of cardiopulmonary bypass circuit and/or as a fluid after cardiopulmonary bypass
Primary outcomes
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Effect of 6% hydroxyethyl starch 130/0.4 as a priming solution on coagulation and blood loss following complex heart valve surgery: a comparison with 5% albumin
Time frame: upto 24hours after cardiopulmonary bypass
The purspose of this study is to investigate the effect of 6% HES 130/0.4 as a component of priming solution on coagulation compared to 5% HA. Rotation thromboelastography (ROTEM) was performed before and 24 h after CPB. Hemoglobin, platelet count and transfusion requirement were assessed for 24 h postoperatively.
Sponsors and collaborators
Lead sponsor
Yonsei University
Other
Registry information
Important dates
- Study start
- 2009
- Primary completion
- 2011
- Study completion
- 2011
- First posted
- Jul 18, 2012
- Registry last updated
- Jul 19, 2012
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.