Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT06026618
Status:
UNKNOWN
Last Update Posted:
2023-09-07
First Post:
2023-07-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Perioperative Management of Preoperative Anemia in Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1294}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2024-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-04', 'studyFirstSubmitDate': '2023-07-11', 'studyFirstSubmitQcDate': '2023-09-04', 'lastUpdatePostDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Hemoglobin', 'timeFrame': 'Baseline and up to 30 days', 'description': 'Change in serum hemoglobin concentration between baseline (at the moment of initial colorectal clinic visit) and day of surgery'}], 'secondaryOutcomes': [{'measure': 'Total iron dose', 'timeFrame': 'up to 30 days', 'description': 'Total iron dose administered from the first visit until surgery'}, {'measure': 'number of days needed to complete treatment', 'timeFrame': 'up to 30 days', 'description': 'days of treatment before surgery'}, {'measure': 'number of complications related to IVI administration', 'timeFrame': 'up to 30 days', 'description': 'number of complications related to IVI administration'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anemia', 'Colorectal Cancer', 'Intravenous Iron Therapy', 'Transfusion', 'Patient Blood Management'], 'conditions': ['Anemia', 'Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'Both preoperative anemia (PA) and perioperative blood transfusion can contribute on poorer outcomes after colon cancer surgery. Anemia is known to be associated with a slower recovery after surgery thus often worsening short-term results, and allogenic red blood cells transfusion (ARBT) are known to promote systemic inflammatory response and affect overall and cancer-specific survival.\n\nPatient Blood Management (PBM) systems are an evidence-based multimodal approach focused on safe and rational use of blood products, mainly through a proper PA assessment, a minimization of procedural blood loos and strict transfusion policies. Given the high prevalence of PA in patients with colorectal cancer (CRC), and its association with adverse events, it is expected that PBM implementation in said scenario carries a decrease in complications and an improved survival rate. Available literature to date supports preoperative anaemia screening and restrictive transfusion policies, nevertheless barriers exist that limit the expected implementation of PBM systems in colorectal surgery.\n\nThe present study aims to evaluate feasibility of a PBM pathway implementation in a high-volume CRC Surgery Unit based on completion of anemia screening and treatment before surgery and changes of allogenic products use along the years. The objective is to estimate the impact of a proper preoperative optimization with iron intravenous infusion (IVI) on PA measured from changes Hemoglobin (Hb) levels in comparison to those of non-anemic patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with colorrectal cancer attended at the hospital', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with Colorectal Cancer\n* Patients with an indication of elective radical surgery\n\nExclusion Criteria:\n\n* treatment with red blood cells transfusion before assessment in the PBM Anemia Clinic\n* non-iron deficient anemia\n* treatment with Sucrose-based IVI or Oral Iron (OI) preparations not strictly controlled by the PBM clinic'}, 'identificationModule': {'nctId': 'NCT06026618', 'briefTitle': 'Perioperative Management of Preoperative Anemia in Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Consorci Sanitari Integral'}, 'officialTitle': 'Perioperative Management of Preoperative Anemia in Colorectal Cancer. Effect of Intravenous Iron Treatment Within a Patient Blood Management on Colorectal Cancer Surgery', 'orgStudyIdInfo': {'id': '21/19'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'cohort 1', 'description': 'non-anemic patients (Hb \\> 13 g/dL)'}, {'label': 'cohort 2', 'description': 'mildly anemic patients (Hb 12-13 mg/dL) without criteria for IVI therapy'}, {'label': 'cohort 3', 'description': 'patients treated with IVI (Hb \\< 12mg/dL or Hb 12-13mg/dL with iron deficiency or risk factors for bleeding)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08970', 'city': 'Sant Joan Despí', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de Sant Joan Despí, CSI', 'geoPoint': {'lat': 41.36718, 'lon': 2.0574}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Consorci Sanitari Integral', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}