An interventional study of Acute normovolemic hemodilution (ANH) and hydroxyethyl starch (HES 130/0.6) in Mitral Regurgitation, Mitral Stenosis and Tricuspid Regurgitation, sponsored by Konkuk University Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-01-30.
Sponsored by Konkuk University Medical Center · Not applicable, Interventional, and Supportive care
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.
Background: 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.
Method: 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.
Intergroup differences of INTEM, EXTEM, FIBTEM and APTEM profiles are analyzed. after anesthesia induction (control) and after weaning form CPB and protamine neutralization (after-CPB) in both groups. In Group-ANH, those are determined after ANH (after-ANH).
As a primary outcome, inter-group difference between maxiaml clot firmness of EXTEM is determined at 10 min after ANH in Group-ANH and that at control.
As secondary outcomes, intergroup differences of Hematocrit (Hct), Na+, K+, HCO3-, Ca2+, osmolarity, s-Cr are determined Intergroup difference of data at T2 are performed.
459 studies on the registry are indexed under Mitral Valve Insufficiency; 148 are open to participants now.
This study's enrollment of 70 is above the median of 61 across 274 interventional studies indexed under Mitral Valve Insufficiency.
Browse Mitral Valve Insufficiency studies →Konkuk University Medical Center is the lead sponsor of 93 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Procedure: Acute normovolemic hemodilution (ANH) · Drug: hydroxyethyl starch (HES 130/0.6)
applying acute normovolemic hemodilution (ANH) by using HES 130/0.4 of 5 ml/kg before the initiation of cardiopulmonary bypass
Maximal clot firmness of EXTEM
Maxiaml clot firmess (MCF) of EXTEM of rotational thromboleastometry
Time frame: 10 min after completion of acute normovolemic hemodilution (ANH)
Clot formation time of EXTEM
Clot formation time of EXTEM of rotational thromboleastometry
Time frame: 10 min after completion of acute normovolemic hemodilution
A10 of FIBTEM
A10 of FIBTEM of rotational thromboelastometry
Time frame: 10 min after completion of acute normovolemic hemodilution
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Konkuk University Medical Center