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The 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 are randomly allocated into one of two groups: in Group-ANH, 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, the inter-group differences between maximal clot firmness of EXTEM will be determined at 10 min after ANH in Group-ANH and that at control.
Background: The 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 are randomly allocated into one of two groups: in Group-ANH(n=29), ANH is applied by using a balanced hydroxyethyl starch (HES 130/0.6); and in Group-C ANH (n=29)is not applied. Intergroup differences of INTEM, EXTEM, FIBTEM, and APTEM profiles are analyzed. after anesthesia induction (control) and after weaning from CPB and protamine neutralization (after-CPB) in both groups. In Group-ANH, those are determined after ANH (after-ANH). As a primary outcome, the inter-group difference between maximal 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, and s-Cr are determined Intergroup differences 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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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tae-Yop Kim, MD, PhD | Contact | +82-2-2030-5445 | taeyop@gmail.com | |
| Wooseul Lee, Bachelor | Contact | +82-2-2030-5448 | wslee.kku@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Tae-Yop Kim, MD, PhD | Konkuk University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Konkuk University Medical Center | Seoul | Seoul | 05030 | South Korea | ||
| Konkuk University Medical Center |
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| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| D008946 | Mitral Valve Stenosis |
| D014262 | Tricuspid Valve Insufficiency |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D016769 | Embolism and Thrombosis |
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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 | hydroxyethyl starch (HES 130/0.6) |
|
| 10 min after completion of acute normovolemic hemodilution |
| Seoul |
| 143-729 |
| South Korea |
|
| D014652 |
| Vascular Diseases |
| D011134 |
| Polysaccharides |