Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT06664320
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-31
First Post:
2024-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mild ANH on Pre-bypass Coagulation Function During Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008944', 'term': 'Mitral Valve Insufficiency'}, {'id': 'D008946', 'term': 'Mitral Valve Stenosis'}, {'id': 'D014262', 'term': 'Tricuspid Valve Insufficiency'}, {'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006895', 'term': 'Hydroxyethyl Starch Derivatives'}], 'ancestors': [{'id': 'D013213', 'term': 'Starch'}, {'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D011134', 'term': 'Polysaccharides'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10-28', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-30', 'studyFirstSubmitDate': '2024-10-27', 'studyFirstSubmitQcDate': '2024-10-27', 'lastUpdatePostDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximal clot firmness of EXTEM', 'timeFrame': '10 min after completion of acute normovolemic hemodilution (ANH)', 'description': 'Maxiaml clot firmess (MCF) of EXTEM of rotational thromboleastometry'}], 'secondaryOutcomes': [{'measure': 'Clot formation time of EXTEM', 'timeFrame': '10 min after completion of acute normovolemic hemodilution', 'description': 'Clot formation time of EXTEM of rotational thromboleastometry'}, {'measure': 'A10 of FIBTEM', 'timeFrame': '10 min after completion of acute normovolemic hemodilution', 'description': 'A10 of FIBTEM of rotational thromboelastometry'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rotational thromboelastometry', 'cardiac surgery', 'acute normovolemic hemodilution', 'hemodilution', 'coagulation'], 'conditions': ['Mitral Regurgitation', 'Mitral Stenosis', 'Tricuspid Regurgitation']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing cardiac surgery with cardiopulmonary bypass who signed written informed consent\n\nExclusion Criteria:\n\n* preoperative renal failure requiring reran replacement therapy\n* preoperative liver disease\n* preoperative low cardiac output (EF \\< 50%)\n* Preoperative IABP application, Atrial fibrillation, Pacemaker\n* contraindication for applying TEE\n* intraoperative withdrawal'}, 'identificationModule': {'nctId': 'NCT06664320', 'briefTitle': 'Mild ANH on Pre-bypass Coagulation Function During Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Konkuk University Medical Center'}, 'officialTitle': 'Impact of Mild Acute Normovolemic Hemodilution on Pre-bypass Coagulation Function During Cardiac Surgery', 'orgStudyIdInfo': {'id': 'KUH1160030-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'patients undergoing cardiac surgery supposed not to get aucte normovolemic hemodilution (ANH) before CPB'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Acute normovolemic hemodilution group', 'description': 'patients undergoing cardiac surgery supposed to get aucte normovolemic hemodilution (ANH) before CPB', 'interventionNames': ['Procedure: Acute normovolemic hemodilution (ANH)', 'Drug: hydroxyethyl starch (HES 130/0.6)']}], 'interventions': [{'name': 'Acute normovolemic hemodilution (ANH)', 'type': 'PROCEDURE', 'description': 'applying acute normovolemic hemodilution (ANH) by using HES 130/0.4 of 5 ml/kg before the initiation of cardiopulmonary bypass', 'armGroupLabels': ['Acute normovolemic hemodilution group']}, {'name': 'hydroxyethyl starch (HES 130/0.6)', 'type': 'DRUG', 'description': 'hydroxyethyl starch (HES 130/0.6)', 'armGroupLabels': ['Acute normovolemic hemodilution group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05030', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Konkuk University Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '143-729', 'city': 'Seoul', 'country': 'South Korea', 'contacts': [{'name': 'Tae-Yop Kim, MD PhD', 'role': 'CONTACT', 'email': 'taeyop@gmail.com', 'phone': '+82-2-2030-5445'}], 'facility': 'Konkuk University Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Tae-Yop Kim, MD, PhD', 'role': 'CONTACT', 'email': 'taeyop@gmail.com', 'phone': '+82-2-2030-5445'}, {'name': 'Wooseul Lee, Bachelor', 'role': 'CONTACT', 'email': 'wslee.kku@gmail.com', 'phone': '+82-2-2030-5448'}], 'overallOfficials': [{'name': 'Tae-Yop Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Konkuk University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Konkuk University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Anesthesiology', 'investigatorFullName': 'Tae-Yop Kim, MD PhD', 'investigatorAffiliation': 'Konkuk University Medical Center'}}}}