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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | patients undergoing cardiac surgery supposed not to get aucte normovolemic hemodilution (ANH) before CPB | |
| Acute normovolemic hemodilution group | Active Comparator | patients undergoing cardiac surgery supposed to get aucte normovolemic hemodilution (ANH) before CPB |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acute normovolemic hemodilution (ANH) | Procedure | applying acute normovolemic hemodilution (ANH) by using HES 130/0.4 of 5 ml/kg before the initiation of cardiopulmonary bypass |
|
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Konkuk University Medical Center | Seoul | 143-729 | South Korea |
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| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| D008946 | Mitral Valve Stenosis |
| D014262 | Tricuspid Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D006895 | Hydroxyethyl Starch Derivatives |
| ID | Term |
|---|---|
| D013213 | Starch |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005936 | Glucans |
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| hydroxyethyl starch (HES 130/0.6) | Drug |
|
| 10 min after completion of acute normovolemic hemodilution |
| D011134 |
| Polysaccharides |