Clinical Trial: Acute Normovolemic Hemodilution on ROTEM in Cardiac Surgery

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Impact of Acute Normovolemic Hemodilution on Whole Blood Coagulation Profile During Post-cardiopulmonary Bypass in Cardiac Surgery: Rotational Thromboelastometry Study

Brief Summary:

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.


Detailed Summary:

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.


Sponsor: Konkuk University Medical Center

Current Primary Outcome: Maximal clot firmness of EXTEM [ Time Frame: 10 min after completion of acute normovolemic hemodilution (ANH) ]

Maxiaml clot firmess (MCF) of EXTEM of rotational thromboleastometry


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Clot formation time of EXTEM [ Time Frame: 10 min after completion of acute normovolemic hemodilution ]
    Clot formation time of EXTEM of rotational thromboleastometry
  • A10 of FIBTEM [ Time Frame: 10 min after completion of acute normovolemic hemodilution ]
    A10 of FIBTEM of rotational thromboelastometry


Original Secondary Outcome: Same as current

Information By: Konkuk University Medical Center

Dates:
Date Received: March 3, 2015
Date Started: December 2011
Date Completion:
Last Updated: July 1, 2016
Last Verified: July 2016