Ignite Creation Date:
2025-12-17 @ 2:47 PM
Ignite Modification Date:
2025-12-23 @ 10:48 PM
Study NCT ID:
NCT01921595
Status:
TERMINATED
Last Update Posted:
2019-03-29
First Post:
2013-08-08
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Balanced Slat Colloid HES 130/0.42 on Coagulation Profiles in Patients Undergoing Spinal Cord Tumor Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D013120', 'term': 'Spinal Cord Neoplasms'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'whyStopped': 'It ended early because it would not be possible to meet the target number.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-27', 'studyFirstSubmitDate': '2013-08-08', 'studyFirstSubmitQcDate': '2013-08-08', 'lastUpdatePostDateStruct': {'date': '2019-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare the effect of coagulation profile in patients receiving intraoperative balanced salt colloid undergoing spinal cord tumor surgery.', 'timeFrame': 'up to 24hrs after anesthesia induction', 'description': 'ROTEM, CBC, PT/aPTT,ABGA, Lactic acid, electrolyte'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['balanced salt colloid, coagulation profiles, spinal cord tumor'], 'conditions': ['Coagulation']}, 'descriptionModule': {'briefSummary': 'The purpose of study is to compare the effect of coagulation profile in patients receiving intraoperative balanced salt colloid undergoing spinal cord tumor surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients over the age of 20 scheduled for spinal tumor removal and fixation\n\nExclusion Criteria:\n\n* 1\\. Renal failure 2. Preexisting congestive heart failure(NYHA III \\~ IV) 3. Anemia 4. Coagulopathy 5. Abnormal liver function 6. Anti coagulation/Anti platelet ,edication 7. Foreigner, illiterate 8. Disabled person,'}, 'identificationModule': {'nctId': 'NCT01921595', 'briefTitle': 'Impact of Balanced Slat Colloid HES 130/0.42 on Coagulation Profiles in Patients Undergoing Spinal Cord Tumor Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '4-2013-0350'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Valanced salt colloid group', 'interventionNames': ['Other: Valanced salt colloid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Valanced salt crystalloid group', 'interventionNames': ['Other: Valanced salt crystalloid group']}], 'interventions': [{'name': 'Valanced salt colloid', 'type': 'OTHER', 'description': 'Maximum dose : 30ml/kg, IV, The infusion of valanced salt colloid is started at bleeding and continued until reach at maximum dose', 'armGroupLabels': ['Valanced salt colloid group']}, {'name': 'Valanced salt crystalloid group', 'type': 'OTHER', 'description': 'Maximum dose : 30ml/kg, IV, The infusion of valanced salt crystalloid is started at bleeding and continued until reach at maximum dose', 'armGroupLabels': ['Valanced salt crystalloid group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}