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Acute Normovolemic Hemodilution on ROTEM in Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT02502448
Recruitment Status : Completed
First Posted : July 20, 2015
Last Update Posted : July 4, 2016
Sponsor:
Information provided by (Responsible Party):
Tae-Yop Kim, MD PhD, Konkuk University Medical Center

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.


Condition or disease Intervention/treatment Phase
Mitral Regurgitation Mitral Stenosis Tricuspid Regurgitation Procedure: Acute normovolemic hemodilution (ANH) Drug: hydroxyethyl starch (HES 130/0.6) Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Impact of Acute Normovolemic Hemodilution on Whole Blood Coagulation Profile During Post-cardiopulmonary Bypass in Cardiac Surgery: Rotational Thromboelastometry Study
Study Start Date : December 2011
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
No Intervention: Control group
patients undergoing cardiac surgery supposed not to get aucte normovolemic hemodilution (ANH) before CPB
Active Comparator: Acute normovolemic hemodilution group
patients undergoing cardiac surgery supposed to get aucte normovolemic hemodilution (ANH) before CPB
Procedure: Acute normovolemic hemodilution (ANH)
applying acute normovolemic hemodilution (ANH) by using HES 130/0.4 of 5 ml/kg before the initiation of cardiopulmonary bypass

Drug: hydroxyethyl starch (HES 130/0.6)



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Clot formation time of EXTEM [ Time Frame: 10 min after completion of acute normovolemic hemodilution ]
    Clot formation time of EXTEM of rotational thromboleastometry

  2. A10 of FIBTEM [ Time Frame: 10 min after completion of acute normovolemic hemodilution ]
    A10 of FIBTEM of rotational thromboelastometry



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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02502448


Locations
Korea, Republic of
Konkuk University Medical Center
Seoul, Korea, Republic of, 143-729
Sponsors and Collaborators
Konkuk University Medical Center

Responsible Party: Tae-Yop Kim, MD PhD, Professor of Anesthesiology, Konkuk University Medical Center
ClinicalTrials.gov Identifier: NCT02502448     History of Changes
Other Study ID Numbers: KUH1160030
First Posted: July 20, 2015    Key Record Dates
Last Update Posted: July 4, 2016
Last Verified: July 2016

Keywords provided by Tae-Yop Kim, MD PhD, Konkuk University Medical Center:
rotational thromboelastometry
cardiac surgery
acute normovolemic hemodilution

Additional relevant MeSH terms:
Mitral Valve Insufficiency
Tricuspid Valve Insufficiency
Mitral Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases