Acute Normovolemic Hemodilution on ROTEM in Cardiac Surgery
NCT ID: NCT02502448
Last Updated: 2020-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
70 participants
INTERVENTIONAL
2016-01-31
2016-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Mild ANH on Pre-bypass Coagulation Function During Cardiac Surgery
NCT06664320
Acute Normovolemic Hemodilution on Serum-creatinine Concentration in Cardiac Surgery
NCT02831270
Impact of Retrograde Autologous Priming on the Coagulation Profile Assessed by Rotation Thromboelastometry (ROTEM) in Patients Undergoing Cardiac Surgery
NCT04239677
Perioperative Colloid vs Crystalloid in Patients Undergoing Colorectal Surgery
NCT01303250
The Effect of the Hydroxyethyl Starch on Kidney Injury in Pediatric Cardiac Surgery
NCT02599155
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control group
patients undergoing cardiac surgery supposed not to get aucte normovolemic hemodilution (ANH) before CPB
No interventions assigned to this group
Acute normovolemic hemodilution group
patients undergoing cardiac surgery supposed to get aucte normovolemic hemodilution (ANH) before CPB
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
hydroxyethyl starch (HES 130/0.6)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
hydroxyethyl starch (HES 130/0.6)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* preoperative liver disease
* preoperative low cardiac output (EF \< 50%)
* Preoperative IABP application, Atrial fibrillation, Pacemaker,
* contraindication for applying TEE
* intraoperative withdrawal
19 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Konkuk University Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Tae-Yop Kim, MD PhD
Professor of Anesthesiology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Konkuk University Medical Center
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KUH1160030
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.