Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-28 @ 6:32 PM
Study NCT ID:
NCT01597232
Status:
COMPLETED
Last Update Posted:
2019-11-20
First Post:
2012-05-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinic Trial for West China Perioperative Transfusion Score (WCPTS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1351}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-02-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-18', 'studyFirstSubmitDate': '2012-05-09', 'studyFirstSubmitQcDate': '2012-05-10', 'lastUpdatePostDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-05-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients received red-cell', 'timeFrame': 'Up to 30 days postoperatively', 'description': 'Proportion of patients received red-cell during peri-operative period'}, {'measure': 'Composite of in-hospital complications and all-cause mortality by day-30', 'timeFrame': 'Up to 30 days postoperatively', 'description': 'Composite of in-hospital complications and all-cause mortality by day-30, and complications were defined as the serious ones that cause prolonged hospitalization, or life threatening, but could get recovery after intense treatment during hospitalization, or life threatening, resulting in significantly decreased quality of life.'}], 'secondaryOutcomes': [{'measure': 'Incidences of in-hospital infectious complications.', 'timeFrame': 'Up to 30 days postoperatively', 'description': 'Infectious complications were defined as infection at any site, such as pulmonary infection, urinary infection, etc.'}, {'measure': 'Intensive Care Unit (ICU) admission rate', 'timeFrame': 'Up to 30 days postoperatively', 'description': 'Proportion of patients with ICU admission'}, {'measure': 'Length of hospital stay (LOS)', 'timeFrame': 'Up to 30 days postoperatively', 'description': 'LOS was defined as the time frame from the day of hospital admission to discharge from the hospital (unit: days).'}, {'measure': 'Hemoglobin level at different time points', 'timeFrame': 'Up to 30 days postoperatively', 'description': 'Hb level was measured at the time points as follows: before operation, completion of operation, 24hrs after operation, before discharge, and before all red cells transfusion'}, {'measure': 'Cost of transfusion and hospitalization', 'timeFrame': 'Up to 30 days postoperatively', 'description': 'Allogeneic blood cost and total in-hospital cost'}, {'measure': 'SF-8 questionnaire', 'timeFrame': 'Up to one year postoperatively', 'description': 'Follow-up of quality of life during one year after operation'}, {'measure': 'Healing status of surgical incision', 'timeFrame': 'Up to 30 days postoperatively', 'description': 'Healing status of surgical incision was divided into grade Ⅰ, Ⅱ, and Ⅲ. Grade Ⅰ was defined as the wound healing nicely without any adverse reaction, grade Ⅱ was defined as the inflammatory wound without the need of re-incision, and grade Ⅲ was defined as the wound suppurated with the need of re-incision for clearance.'}, {'measure': 'All-cause mortality during 1-year after operation', 'timeFrame': 'Up to one year postoperatively', 'description': 'All-cause mortality by day-60, day-180 and 1-year after operation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Transfusion trigger', 'Hemoglobin level'], 'conditions': ['Transfusion Related Complications']}, 'referencesModule': {'references': [{'pmid': '37052133', 'type': 'DERIVED', 'citation': 'Liao R, Liu J, Zhang W, Zheng H, Zhu Z, Sun H, Yu Z, Jia H, Sun Y, Qin L, Yu W, Luo Z, Chen Y, Zhang K, Ma L, Yang H, Wu H, Liu L, Yuan F, Xu H, Zhang J, Zhang L, Liu D, Huang H. Individualized red-cell transfusion strategy for non-cardiac surgery in adults: a randomized controlled trial. Chin Med J (Engl). 2023 Dec 5;136(23):2857-2866. doi: 10.1097/CM9.0000000000002584.'}]}, '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 anesthesiologists or surgeons. 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 adrenalin for maintaining normal cardiac output, fraction of inspired oxygen, core temperature, and angina. To verify this hypothesis, the investigators present West China Perioperative Transfusion Score (WCPTS) 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': "Surgery and trauma are the most common reasons for major blood loss, and blood transfusion provide guarantee for massive hemorrhagic surgery, especially orthopedic, cardiac, liver, and gynecologic procedures. 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 anesthesiologists or surgeons. 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 adrenalin for maintaining normal cardiac output, fraction of inspired oxygen for maintaining spO2≧95%, core temperature, and angina.\n\nPeri-Operative Transfusion Trigger Score, POTTS The initial score is 6. If a patient's cardiac output is normal without infusion of adrenalin, his spO2 could be maintained more than 95% with FiO2≤35%, his core temperature is less than 38℃, and he has no angina, his score is 6.\n\nIf a patient has one or more problems, including his normal cardiac output should be maintained by infusion of adrenalin with its rate ≤0.05μg/kg.min, or his spO2 is maintained more than 95% with 36\\~50% FiO2, or his core temperature is between 38℃ to 40℃, or chest pain due to exercise,manual labor,or excitement, his score should be added 1 point for each problem.\n\nIf a patient has one or more problems, including his normal cardiac output should be maintained by infusion of adrenalin with its rate \\>0.06μg/kg.min, or his spO2 is maintained more than 95% with \\>51% FiO2, or his core temperature is \\>40℃, or sudden onset of chest pain at rest, his score should be added 2 point for each problem.\n\nThe initial POTTS 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.\n\nFor example, if a patient need ≤0.05μg/kg.min adrenalin to maintain his normal cardiac output (+1), his spO2 could be maintained more than 95% with FiO2≤35%, his core temperature is less than 38℃, and he has sudden onset of chest pain at rest (+2), his POTTS score could be calculated as 6 +1 (≤0.05μg/kg.min adrenalin to maintain his normal cardiac output) +2 (sudden onset of chest pain at rest), and his POTTS score is 9. That means this patient's transfusion trigger is 9g/dL, and his hemoglobin level should be maintained above 9 at this situation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Height of usual place of residence less than 2,500 metres above sea level\n* Perioperative hemoglobin level possibly less than 10g/dL\n\nExclusion Criteria:\n\n* Emergency operation\n* ASA classification V or VI\n* Serious blood system diseases\n* Dysfunction of hemoglobin\n* Hypervolemic hemodilution\n* Tumor metastasis\n* Psychopathy\n* Refuse to sign consent'}, 'identificationModule': {'nctId': 'NCT01597232', 'acronym': 'WCPTS', 'briefTitle': 'Clinic Trial for West China Perioperative Transfusion Score (WCPTS)', 'organization': {'class': 'OTHER', 'fullName': 'West China Hospital'}, 'officialTitle': 'Effect of West China Perioperative Transfusion Score (WCPTS) on Red Blood Cells Transfusion in Patients Undergoing Major Surgery: a Prospective, Multicenter, Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'WCPTS120508'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transfusion trigger based on WCPTS', 'description': 'Determination of whether a patient need red blood cells transfusion or which hemoglobin level should be maintained is based on WCPTS.', 'interventionNames': ['Other: Transfusion trigger based on WCPTS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hemoglobin level 10g/dL', 'description': "The patient's hemoglobin level is maintained more than 10g/dL perioperatively.", 'interventionNames': ['Other: Maintenance of hemoglobin level more than 10g/dL']}, {'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': ['Other: Transfusion trigger based on experience']}], 'interventions': [{'name': 'Transfusion trigger based on WCPTS', 'type': 'OTHER', 'description': 'Determination of whether a patient needs red blood cell transfusion or which hemoglobin level should be maintained is based on WCPTS', 'armGroupLabels': ['Transfusion trigger based on WCPTS']}, {'name': 'Maintenance of hemoglobin level more than 10g/dL', 'type': 'OTHER', 'description': "The patient's hemoglobin level is maintained more than 10g/dL perioperatively", 'armGroupLabels': ['Hemoglobin level 10g/dL']}, {'name': 'Transfusion trigger based on experience', 'type': 'OTHER', 'description': "Determination of whether the patient need red blood cell transfusion or which hemoglobin level should be maintained is based on the physician's experience", 'armGroupLabels': ['Transfusion trigger based on experience']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'Department of Anesthesiology, West China Hospital, Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'overallOfficials': [{'name': 'Ren Liao, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University'}, {'name': 'Jin Liu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West China Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Ren Liao', 'investigatorAffiliation': 'West China Hospital'}}}}