Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2026-04-13 @ 5:53 AM
Study NCT ID:
NCT02139995
Status:
UNKNOWN
Last Update Posted:
2014-05-16
First Post:
2014-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
West-China Transfusion Score for Critically-ill Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-05-13', 'studyFirstSubmitDate': '2014-05-11', 'studyFirstSubmitQcDate': '2014-05-13', 'lastUpdatePostDateStruct': {'date': '2014-05-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of death and serious complications', 'timeFrame': '28 days'}], 'secondaryOutcomes': [{'measure': 'Transfusion rate and transfusion volume of red blood cells', 'timeFrame': '28 days'}, {'measure': 'ventilator-free days in 28 days', 'timeFrame': '28 days', 'description': 'The time that patients do not need ventilaton support'}, {'measure': 'length of stay in ICU or in hospital', 'timeFrame': '28 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['transfusion', 'trigger', 'critically-ill'], 'conditions': ['Transfusion Related Complication', 'Critical Illness']}, 'descriptionModule': {'briefSummary': "Guidelines for blood transfusion have been issued for years. According to these guidelines, red blood cells (RBCs) transfusion should be given when the hemoglobin level is less than 6g/dL or 7g/dL and is unnecessary when the level is more than 10g/dL. However, in all the guidelines, the determination of whether RBCs should be administered when the hemoglobin level is in the range of 6\\~10g/dL is based on the judgment from doctors. Index of transfusion trigger for patients with hemoglobin level between 6g/dL and 10g/dL is necessary and important in clinical practice.\n\nBased on the aim of blood transfusion that maintain the balance of oxygen supply and oxygen consumption, the investigators hypothesize that index of transfusion trigger for patients with hemoglobin level between 6g/dL and 10g/dL could be calculated by parameters including infusion rate of inotropic drugs for maintaining normal cardiac output, fraction of inspired oxygen, core temperature, and torlerance to anemia. To verify this hypothesis, the investigators present West China Transfusion Score for Critically-ill Patients(WCTS-CP) for the trigger of transfusion according to the patient's history and monitoring parameters, and the investigators design a randomized controlled clinical trial to test this score.", 'detailedDescription': "Anemia is a common phenomenon in critically ill patients, and blood transfusion may provide guarantee for oxygen delivery. On the other hand, blood transfusion is associated with many risks including hemolytic and nonhemolytic reactions, transfusion related acute lung injury (TRALI), and others. Besides, blood is insufficient worldwide. How to eliminate allogeneic blood transfusion is an important part in clinical practice.\n\nGuidelines for blood transfusion have been issued for years. According to these guidelines, red blood cells (RBCs) transfusion should be given when the hemoglobin level is less than 6g/dL or 7g/dL and is unnecessary when the level is more than 10g/dL. However, in all the guidelines, the determination of whether RBCs should be administered when the hemoglobin level is in the range of 6\\~10g/dL is based on the judgment from specific doctors. Index of transfusion trigger for critically ill patients with hemoglobin level between 6g/dL and 10g/dL is necessary and important in clinical practice.\n\nBased on the aim of blood transfusion that maintain the balance of oxygen supply and oxygen consumption, the investigators hypothesize that index of transfusion trigger for patients with hemoglobin level between 6g/dL and 10g/dL could be calculated by parameters including infusion rate of inotropic drugs for maintaining normal cardiac output, fraction of inspired oxygen for maintaining saturation of oxygen≧95%, core temperature, and torlerance to anemia.\n\nThe investigators set down the West China Transfusion Score for Critically-ill Patients(WCTS-CP) ，the initial score is 6. If a patient's cardiac output is normal without infusion of inotropic drugs, the heartbeat less than 100 per minute，his saturation of oxygen could be maintained more than 95%, his core temperature is less than 38℃, and he has no history of ischemic cardiovascular disease , and he is below 55 of age，his score is 6.\n\nIf a patient has one or more problems, his score should be added 1 point for each problem.\n\nThe initial WCTS-CP score is 6, and the patient's score is calculated by the sum of each item.\n\nScore 6：The transfusion trigger is 6g/dL, and the the patient's Hemoglobin level should be maintained not less than 6g/dL.\n\nScore 7：The transfusion trigger is 7g/dL, and the the patient's Hemoglobin level should be maintained not less than 7g/dL.\n\nScore 8：The transfusion trigger is 8g/dL, and the the patient's Hemoglobin level should be maintained not less than 8g/dL.\n\nScore 9：The transfusion trigger is 9g/dL, and the the patient's Hemoglobin level should be maintained not less than 9g/dL.\n\nScore 10 or \\>10：The transfusion trigger is 10g/dL, and the the patient's Hemoglobin level should be maintained not less than 10g/dL."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Height of usual place of residence less than 2,500 metres above sea level\n* Hemoglobin level possibly less than 10g/dL\n\nExclusion Criteria:\n\n* Pregnant women\n* Age less than 18\n* Serious blood system diseases\n* Dysfunction of hemoglobin\n* Tumor metastasis\n* Psychopathy\n* Refuse to sign consent'}, 'identificationModule': {'nctId': 'NCT02139995', 'briefTitle': 'West-China Transfusion Score for Critically-ill Patients', 'organization': {'class': 'OTHER', 'fullName': 'West China Hospital'}, 'officialTitle': 'West-China Transfusion Score for Critically-ill Patients', 'orgStudyIdInfo': {'id': 'Ethics-42'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transfusion trigger based on WCTS-CP', 'description': 'Determination of whether a patient need red blood cells transfusion or which hemoglobin level should be maintained is based on WCTS-CP', 'interventionNames': ['Behavioral: RBC transfusion based on different protocols']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Transfusion trigger based on experience', 'description': "Determination of whether a patient need red blood cell transfusion or which hemoglobin level should be maintained is base on the physician's experience", 'interventionNames': ['Behavioral: RBC transfusion based on different protocols']}], 'interventions': [{'name': 'RBC transfusion based on different protocols', 'type': 'BEHAVIORAL', 'description': "transfusion trigger for experimental group is the WCTS-CP；for active comparator is the physician's experience", 'armGroupLabels': ['Transfusion trigger based on WCTS-CP', 'Transfusion trigger based on experience']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'West China Hospital', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'centralContacts': [{'name': 'Jin Liu, M.D', 'role': 'CONTACT', 'phone': '18980601539'}, {'name': 'Yun yi Deng, M.D', 'role': 'CONTACT', 'email': 'dengyiyun1@medmail.com.cn', 'phone': '18980602139'}], 'overallOfficials': [{'name': 'Jin Liu, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'West China Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West China Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'ICU', 'investigatorFullName': 'Yiyun Deng', 'investigatorAffiliation': 'West China Hospital'}}}}