Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-25 @ 9:10 PM
Study NCT ID:
NCT04797156
Status:
COMPLETED
Last Update Posted:
2025-04-04
First Post:
2021-03-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combined IV and Topical TXA in Major Spine Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001416', 'term': 'Back Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014148', 'term': 'Tranexamic Acid'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-10-04', 'size': 361520, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-04-01T13:06', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The patient, surgeon, and anesthesiologist in the case will be blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'Patients will be assigned randomly using a computer-generated table of numbers to one of the three groups:\n\n1. High Dose Intravenous TXA (hTXA group)\n2. Low Dose Intravenous TXA (lTXA group)\n3. Combined Intravenous and Topical TXA group (cTXA group).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-01', 'studyFirstSubmitDate': '2021-03-10', 'studyFirstSubmitQcDate': '2021-03-10', 'lastUpdatePostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Hematocrit level', 'timeFrame': 'Baseline and Post-operative day 1, 2 and 3', 'description': 'The amount of post-operative blood loss during the first 24, 48 and 72 hours in patients undergoing multilevel spine surgery. Specifically, the hematocrit number difference between baseline and post-operative day 1, 2 and 3.'}], 'secondaryOutcomes': [{'measure': 'Post-operative drain output', 'timeFrame': 'Post-operative day 1, 2 and 3', 'description': 'The amount of post-operative drain output (ml) during the first 24, 48 and 72 hours in patients undergoing multilevel spine surgery.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tranexamic acid', 'Spine surgery'], 'conditions': ['Spine Surgery', 'Back Pain']}, 'descriptionModule': {'briefSummary': 'This is a randomized study. The purpose of this study is to evaluate the effect of tranexamic acid in patients undergoing multilevel spine surgery. 75 patients undergoing multi-level spine surgery will be enrolled at Mount Sinai West. Study participation will last from the time of pre-operative evaluation to the time of discharge from hospital. Specifically, the study team will compare tranexamic acid given only intravenously vs. given both topically and intravenously vs. given only intravenously but at a higher dosage. The study team hypothesizes that patient who received combined topical and intravenous TXA (low dose) have similar or decreased overall blood loss postoperatively compared to patient who received high or low dose intravenous TXA alone.', 'detailedDescription': "Prospective triple-blinded randomized control trial. The surgeon will provide study information (protocol, consent, general information) to patients in the surgeon's office. Recruitment will be done through a coordination of the operating schedule and the surgeon's office. Patients presenting for preoperative visits at the surgeon's office or the preoperative joint clinic will be approached. On the day of the surgery, the subject will meet the research team in the holding area. The team will finalize participation and ask the subject about the signed consent forms and answer any additional questions. All patients will be provided with copies of the IRB protocol and consent if they wish to have it. Copy of the consent form will be sent in a secured email to the potential subject. The email will be secured by entering in \\[SECURE\\] in the e-mail subject line. Once recruited blinding assessments will be done by the study team.\n\nPatients will be assigned randomly using a computer-generated table of numbers to one of the three groups: 1) High Dose Intravenous TXA (hTXA group), 2) Low Dose Intravenous TXA (lTXA group), or 3) Combined Intravenous and Topical TXA group (cTXA group). Surgical team will perform the required spine procedure. Study personnel will make the medication which will be labelled as study drug for surgical and anesthesia team to give during the procedure. Patients assigned to hTXA group will receive 50mg/kg IV TXA loading dose with a 5mg/kg/hr maintenance dose, and normal saline poured over 5 minutes at the wound prior to closure. Patients assigned to lTXA group will receive 20mg/kg IV TXA loading dose with a 5mg/kg/hr maintenance dose, and normal saline poured over 5 minutes at the wound prior to closure. Patients assigned to cTXA group will received 20mg/kg V TXA loading dose with a 5mg/kg/hr maintenance dose, and 2g topical TXA poured over 5 minutes at the would prior to closure. Otherwise, the patient, surgeon, and anesthesiologist in the case will be blinded."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults 18-80 years old\n* Undergo major multilevel spine surgery (2-8 levels)\n* Male or female\n\nExclusion Criteria:\n\n* ASA class V\n* Urgent or emergent surgery,\n* Morbid obesity\n* Patients with known coagulopathy disorder, hx of thromboembolic event \\<1 year, renal insufficiency, hepatic dysfunction, serious cardiac disease\n* Patients with known allergy to TXA or receiving antiplatelet and/or anticoagulant drugs\n* Religious or other belief that limit blood transfusion,\n* Surgery duration more than 6 hours\n* Patient refusal or inability to consent'}, 'identificationModule': {'nctId': 'NCT04797156', 'briefTitle': 'Combined IV and Topical TXA in Major Spine Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'The Effect of Combined Intravenous and Topical TXA in Major Multilevel Spine Surgery: A Prospective Randomized Trial', 'orgStudyIdInfo': {'id': 'GCO 19-1137'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High Dose Intravenous TXA (hTXA group)', 'description': 'Patients assigned to hTXA group will receive 50mg/kg IV TXA loading dose with a 5mg/kg/hr maintenance dose, and normal saline poured over 5 minutes at the wound prior to closure.', 'interventionNames': ['Drug: High Dose Tranexamic acid', 'Drug: Normal saline']}, {'type': 'EXPERIMENTAL', 'label': 'Low Dose Intravenous TXA (lTXA group)', 'description': 'Patients assigned to lTXA group will receive 20mg/kg IV TXA loading dose with a 5mg/kg/hr maintenance dose, and normal saline poured over 5 minutes at the wound prior to closure.', 'interventionNames': ['Drug: Low Dose Tranexamic acid', 'Drug: Normal saline']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Combined Intravenous and Topical TXA group (cTXA group)', 'description': 'Patients assigned to cTXA group will received 20mg/kg V TXA loading dose with a 5mg/kg/hr maintenance dose, and 2g topical TXA poured over 5 minutes at the would prior to closure', 'interventionNames': ['Drug: Low Dose Tranexamic acid', 'Drug: Tranexamic acid Topical']}], 'interventions': [{'name': 'High Dose Tranexamic acid', 'type': 'DRUG', 'otherNames': ['hTXA'], 'description': '50mg/kg IV TXA', 'armGroupLabels': ['High Dose Intravenous TXA (hTXA group)']}, {'name': 'Low Dose Tranexamic acid', 'type': 'DRUG', 'otherNames': ['lTXA'], 'description': '20mg/kg IV TXA', 'armGroupLabels': ['Combined Intravenous and Topical TXA group (cTXA group)', 'Low Dose Intravenous TXA (lTXA group)']}, {'name': 'Tranexamic acid Topical', 'type': 'DRUG', 'otherNames': ['TXA'], 'description': '2g topical TXA', 'armGroupLabels': ['Combined Intravenous and Topical TXA group (cTXA group)']}, {'name': 'Normal saline', 'type': 'DRUG', 'otherNames': ['NS'], 'description': 'Normal saline poured on wound', 'armGroupLabels': ['High Dose Intravenous TXA (hTXA group)', 'Low Dose Intravenous TXA (lTXA group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10019', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai West Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Yan Lai, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mount Sinai West and Morningside Hospitals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Anesthesiology, Perioperative & Pain Medicine', 'investigatorFullName': 'Yan Lai', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}