Impact of Acute Normovolemic Hemodilution on Whole Blood Coagulation Profile During Post-cardiopulmonary Bypass in Cardiac Surgery: Rotational Thromboelastometry Study
Sponsor study identifier
interventional
70
1 country
1
Study Start
January 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2016
Actual (reported)Study Completion
June 2016
Actual (reported)Impact of acute normovolemic hemodilution (ANH) using hydroxyethyl starch before initiating cardiopulmonary bypass (CPB) on whole blood viscoelastic profile after CPB has not been well established. Patients undergoing cardiac surgery employing moderate hypothermic CPB (n=40) are randomly allocated into one of two groups: in Group-ANH(n=20), ANH is applied by using a balanced hydroxyethyl starch (HES 130/0.6); and in Group-C, ANH is not applied. After weaning from CPB, intergroup differences of INTEM, EXTEM, FIBTEM and APTEM profiles are analyzed. As a primary outcome, inter-group difference between maxiaml clot firmness of EXTEM will be determined at 10 min after ANH in Group-ANH and that at control.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 3, 2015
Actual (reported)July 20, 2015
Actual (reported)January 2016
Date type not reportedThis date has not been verified as actual or estimated.
June 2016
Actual (reported)June 2016
Actual (reported)Maximal clot firmness of EXTEM
Maxiaml clot firmess (MCF) of EXTEM of rotational thromboleastometry
10 min after completion of acute normovolemic hemodilution (ANH)
Clot formation time of EXTEM
10 min after completion of acute normovolemic hemodilution
A10 of FIBTEM
10 min after completion of acute normovolemic hemodilution
patients undergoing cardiac surgery supposed not to get aucte normovolemic hemodilution (ANH) before CPB
patients undergoing cardiac surgery supposed to get aucte normovolemic hemodilution (ANH) before CPB
applying acute normovolemic hemodilution (ANH) by using HES 130/0.4 of 5 ml/kg before the initiation of cardiopulmonary bypass
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Konkuk University Medical Center
Seoul, 143-729, South Korea
70 participants (actual enrollment reported by the registry).
First Submitted
March 3, 2015
First Posted
July 20, 2015
Study Start
January 2016
Date type not reportedThis date has not been verified as actual or estimated.
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Primary Completion
June 2016
Actual (reported)Study Completion
June 2016
Actual (reported)Last Updated
January 30, 2020
Record last verified: 2020-01
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Source: ClinicalTrials.gov.
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