Acute Normovolemic Hemodilution on ROTEM in Cardiac Surgery

Study Overview
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Brief Summary
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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 Description
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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.

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

Conditions
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Mitral Regurgitation, Mitral Stenosis, Tricuspid Regurgitation

Intervention / Treatment
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* Procedure: Acute normovolemic hemodilution (ANH)
* Drug: hydroxyethyl starch (HES 130/0.6)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients undergoing cardiac surgery with cardiopulmonary bypass who signed written informed consent Exclusion Criteria: preoperative renal failure requiring reran replacement therapy preoperative liver disease preoperative low cardiac output (EF < 50%) Preoperative IABP application, Atrial fibrillation, Pacemaker, contraindication for applying TEE intraoperative withdrawal

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>patients undergoing cardiac surgery supposed not to get aucte normovolemic hemodilution (ANH) before CPB | |
| Active Comparator: Acute normovolemic hemodilution group<br>patients undergoing cardiac surgery supposed to get aucte normovolemic hemodilution (ANH) before CPB | Procedure: Acute normovolemic hemodilution (ANH)<br>* applying acute normovolemic hemodilution (ANH) by using HES 130/0.4 of 5 ml/kg before the initiation of cardiopulmonary bypass<br>Drug: hydroxyethyl starch (HES 130/0.6)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal clot firmness of EXTEM | Maxiaml clot firmess (MCF) of EXTEM of rotational thromboleastometry | 10 min after completion of acute normovolemic hemodilution (ANH) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clot formation time of EXTEM | Clot formation time of EXTEM of rotational thromboleastometry | 10 min after completion of acute normovolemic hemodilution | 
| A10 of FIBTEM | A10 of FIBTEM of rotational thromboelastometry | 10 min after completion of acute normovolemic hemodilution | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rotational thromboelastometry, cardiac surgery, acute normovolemic hemodilution