Mitral Regurgitation Clinical Trial
Official title:
Impact of Acute Normovolemic Hemodilution on Whole Blood Coagulation Profile During Post-cardiopulmonary Bypass in Cardiac Surgery: Rotational Thromboelastometry Study
NCT number | NCT02502448 |
Other study ID # | KUH1160030 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2016 |
Est. completion date | June 2016 |
Verified date | January 2020 |
Source | Konkuk University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 70 |
Est. completion date | June 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Konkuk University Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Konkuk University Medical Center |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximal clot firmness of EXTEM | Maxiaml clot firmess (MCF) of EXTEM of rotational thromboleastometry | 10 min after completion of acute normovolemic hemodilution (ANH) | |
Secondary | Clot formation time of EXTEM | Clot formation time of EXTEM of rotational thromboleastometry | 10 min after completion of acute normovolemic hemodilution | |
Secondary | A10 of FIBTEM | A10 of FIBTEM of rotational thromboelastometry | 10 min after completion of acute normovolemic hemodilution |
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