Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2025-12-25 @ 3:19 PM
Study NCT ID:
NCT03888768
Status:
UNKNOWN
Last Update Posted:
2019-11-01
First Post:
2019-03-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ProPBM : A Modified Patient Blood Management Protocol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018798', 'term': 'Anemia, Iron-Deficiency'}, {'id': 'D000090463', 'term': 'Iron Deficiencies'}, {'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D000747', 'term': 'Anemia, Hypochromic'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'patient will be randomised into ProPBM and standard care arm'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'ProPBM arm and standard Care arm'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-30', 'studyFirstSubmitDate': '2019-03-01', 'studyFirstSubmitQcDate': '2019-03-22', 'lastUpdatePostDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of perioperative allogenic blood transfusion.', 'timeFrame': 'Participants will be followed from date of hospital entry until date of discharge up to 6 months', 'description': 'To assess the incidence of allogenic blood transfusion occurring within the total length of hospital stay within the same admission of a surgical procedure performed under general or regional anaesthesia'}], 'secondaryOutcomes': [{'measure': 'Change in haemoglobin (Hb) concentrations from baseline', 'timeFrame': 'Preoperative basline and one day before surgery after MonoFer administration expected up to 2 weeks', 'description': 'To assess the extent of increase in preoperative hemoglobin levels(baseline) and hemoglobin level one day before surgery, after the administration of IV MonoFer in ProPBM arm'}, {'measure': 'Quality of Life of patient', 'timeFrame': 'preoperative (baseline), one month, six month', 'description': "To assess patient's quality of life using Short Form (12) Health Survey(SF-12) is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight domain scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability."}, {'measure': 'Postoperative Morbidity', 'timeFrame': 'Day one postoperative, postoperative one week,postoperative one month, postoperative six month', 'description': 'To assess postoperative morbidity using Postoperative Morbidity Survey(POMS).Patients are assessed for diagnostic features in nine domains (pulmonary, infectious, renal, gastrointestinal, cardiovascular, neurological, haematological, wound and pain). For each domain, either presence or absence of morbidity is recorded on the basis of objective criteria.'}, {'measure': 'Mortality rate', 'timeFrame': 'Participants will be followed up expected till 6 months', 'description': 'To assess the incidence of mortality after surgery in both ProPBM arm and standard arm'}, {'measure': 'Total hospital stay', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 2 weeks', 'description': 'Participants will be followed for the duration of hospital stay'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['intravenous iron isomaltoside(monofer)', 'iron deficiency', 'anaemia', 'patient blood management'], 'conditions': ['Iron-deficiency']}, 'descriptionModule': {'briefSummary': 'The introduction of a modified perioperative patient blood management protocol with intravenous iron intervention for iron deficiency anaemic patients would reduce the need for allogenic blood transfusion and reduce perioperative morbidity and mortality.', 'detailedDescription': 'Patient blood management (PBM), refers to "the timely application of evidence based medical and surgical concepts designed to maintain haemoglobin concentration, optimise haemostasis and minimize blood loss in an effort to improve patient outcome.\n\nPBM relies on three corresponding aspects:\n\n1. Optimising haemopoiesis,\n2. Minimising bleeding and blood loss\n3. Harnessing and optimising physiological tolerance of anaemia.\n\nTherefore, this randomised control trial aims to study the effect of applying a modified patient blood management protocol on the perioperative allogenic blood transfusion incidence, mortality and morbidity in patients undergoing major surgery in gynaecology, intraabdominal surgery and orthopaedics comparing with current practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergoing major surgery in gynaecology, gastrointestinal surgery and orthopaedics\n* Major surgery defined as either Intrabdominal surgery or main joint surgery, Risk of blood loss \\>15% blood volume\n* Aged between 18 to 80 years of age\n* The patient must be willing and able to provide written informed consent for the study\n\nExclusion Criteria:\n\n* Allergy or known sensitivity to parenteral iron\n* Hypersensitivity to the active substance, Iron(III) Isomaltoside or any of its excipients listed in the summary of product characteristics\n* Patients with iron overload'}, 'identificationModule': {'nctId': 'NCT03888768', 'briefTitle': 'ProPBM : A Modified Patient Blood Management Protocol', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ministry of Health, Malaysia'}, 'officialTitle': 'ProPBM : A Randomised Control Trial Comparing a Modified Patient Blood Management Protocol Against Standard Care for Patients Undergoing Major Surgery', 'orgStudyIdInfo': {'id': '46050'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ProPBM', 'description': 'Pre-operative: patient will be screened for iron deficiency and anemia and administered IV monofer Intra-operative:IV tranexamic Acid 1gm will be administered at the beginning of surgery and blood transfusion triggered by Allowable blood loss Post-operative: IV Iron monofer will be given to those with estimated blood loss \\>1L and subsequent post operative follow up till 6month', 'interventionNames': ['Drug: MonoFer']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Care', 'description': 'patient will received standard hospital practise'}], 'interventions': [{'name': 'MonoFer', 'type': 'DRUG', 'otherNames': ['isomaltoside'], 'description': 'Administration of IV Monofer will be given according to body weight as recommended by the drug manufacturer.', 'armGroupLabels': ['ProPBM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59100', 'city': 'Kuala Lumpur', 'state': 'Kuala Lumpur', 'status': 'RECRUITING', 'country': 'Malaysia', 'contacts': [{'name': 'UM', 'role': 'CONTACT', 'email': 'ummc@ummc.edu.my', 'phone': '0379494422'}, {'name': 'kevin ng', 'role': 'CONTACT', 'email': 'nivekng@gmail.com', 'phone': '0122987708'}, {'name': 'Kevin Ng', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Malaya Medical Centre, Jalan Universiti', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}], 'centralContacts': [{'name': 'Jenq Uei Tan', 'role': 'CONTACT', 'email': 'jenquei84@gmail.com', 'phone': '+60165213692'}, {'name': 'Kevin Ng', 'role': 'CONTACT', 'email': 'nivekng@gmail.com', 'phone': '+60122987708'}], 'overallOfficials': [{'name': 'Kevin Ng', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMMC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ministry of Health, Malaysia', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'University of Malaya', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Trainee of Master of Anaesthesiology University of Malaya', 'investigatorFullName': 'Tan Jenq Uei', 'investigatorAffiliation': 'Ministry of Health, Malaysia'}}}}