Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-04-06 @ 1:37 PM
Study NCT ID:
NCT07392034
Status:
COMPLETED
Last Update Posted:
2026-02-06
First Post:
2026-01-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Tranexamic Acid Reducing Blood Loss During Maxillofacial Trauma Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-02', 'studyFirstSubmitDate': '2026-01-19', 'studyFirstSubmitQcDate': '2026-02-02', 'lastUpdatePostDateStruct': {'date': '2026-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mean intraoperative blood loss', 'timeFrame': 'Immediately at the end of surgery', 'description': 'mean intraoperative blood loss between patients receiving intravenous tranexamic acid and those receiving placebo during maxillofacial trauma surgery.'}], 'secondaryOutcomes': [{'measure': 'mean drop in hemoglobin levels postoperatively', 'timeFrame': '03 hours after post operatively', 'description': 'To assess the mean drop in hemoglobin levels postoperatively between the TXA and placebo groups.'}, {'measure': 'intraoperative blood transfusion', 'timeFrame': 'Preoperative', 'description': 'To evaluate the need for intraoperative blood transfusion between the two groups.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tranexamic acid', 'Oral and maxillofacial trauma surgery', 'Blood loss', 'Hemoglobin', 'Duration of surgery'], 'conditions': ['Hemoglobin Level Measurement', 'Blood Loss During Surgery', 'Duration of Surgery']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Wong J, George RB, Hanley CM, Saliba C, Yee DA, Jerath A. Tranexamic acid: current use in obstetrics, major orthopedic, and trauma surgery. Can J Anaesth. 2021;68(6):894-917.'}, {'type': 'BACKGROUND', 'citation': 'Ramirez RJ, Spinella PC, Bochicchio GV. Tranexamic Acid Update in Trauma. Crit Care Clin. 2017;33(1):85-99.'}, {'type': 'BACKGROUND', 'citation': 'Patel PA, Wyrobek JA, Butwick AJ, Pivalizza EG, Hare GMT, Mazer CD, et al. Update on Applications and Limitations of Perioperative Tranexamic Acid. Anesth Analg. 2022;135(3):460-73.'}, {'type': 'BACKGROUND', 'citation': 'Gruen RL, Mitra B, Bernard SA, McArthur CJ, Burns B, Gantner DC, et al. Prehospital Tranexamic Acid for Severe Trauma. N Engl J Med. 2023;389(2):127-36.'}, {'type': 'BACKGROUND', 'citation': 'Colomina MJ, Contreras L, Guilabert P, Koo M, E MN, Sabate A. Clinical use of tranexamic acid: evidences and controversies. Braz J Anesthesiol. 2022;72(6):795-812.'}, {'type': 'BACKGROUND', 'citation': 'Wu B, Lv K. Effect of tranexamic acid on postoperative blood loss. Br J Oral Maxillofac Surg. 2024;62(5):489-92.'}, {'type': 'BACKGROUND', 'citation': 'Ockerman A, Vanassche T, Garip M, Vandenbriele C, Engelen MM, Martens J, et al. Tranexamic acid for the prevention and treatment of bleeding in surgery, trauma and bleeding disorders: a narrative review. Thromb J. 2021;19(1):54.'}, {'type': 'BACKGROUND', 'citation': 'Khiabani K, Ahmadfar M, Labafchi A, Gosheh MR, Samieirad S. Is Preoperative Administration of Tranexamic Acid Effective on Blood Loss Reduction in Mandibular Fracture Surgeries? A Triple-Blind Randomized Clinical Trial. J Oral Maxillofac Surg. 2021;79(2):429.e1-.e7.'}, {'type': 'BACKGROUND', 'citation': 'Dunphy L, Williams R. Immune thrombocytopenic purpura presenting with spontaneous gingival haemorrhage in pregnancy. BMJ Case Rep. 2019;12(1).'}, {'type': 'BACKGROUND', 'citation': 'Chen MWJ, Yong CW, Lum JL. Use of an improvised clamp to manage bleeding tongue injuries. Am J Emerg Med. 2021;39:252.e1-.e2.'}]}, 'descriptionModule': {'briefSummary': 'Tranexamic acid (TXA) is an inexpensive, easily used and relatively safe drug. It inhibits plasminogen activation and plasmin thus retards clot disintegration.Therapeutic application of tranexamic acid in trauma for preventing blood loss has been documented since long. Since blood loss causes several serious complications, it is compensated emergently by transfusion of blood or its products. However, transfusion of blood and products always carries a risk of inadvertent transmission of infection, antigen-antibody reactions and additional cost all of which can be prevented if blood loss is reduced. Morbidity associated with the delay in compensating the blood loss could also be prevented by pharmaceutically preventing hemorrhage.', 'detailedDescription': 'During management of maxillofacial injuries, hemostasis is essential to clear the airway also. It is reported that blood loss is the most common complication following maxillofacial fractures and their treatment.TXA oral rinse has been used for preventing excessive hemorrhage for patients with coagulopathies. IV TXA has also been proven to be effective in reducing bleeding in healthy adults undergoing third molar surgery. Administration of TXA has also been evaluated and found effective in reducing post-surgical hemorrhage during and after bimaxillary orthognathic surgery.\n\nThis study has been planned to evaluate how efficacious is preoperative tranexamic acid in decreasing blood loss while performing surgery in cases with maxillofacial trauma in our local setting. the study results will provide local evidence and will support the incorporation of safe and inexpensive drug i.e., TXA into trauma clinical practice guidelines and local treatment protocols.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* either gender.\n* presenting within seven days of trauma.\n* planned for maxillofacial surgery.\n\nExclusion Criteria:\n\n* Patients with international normalized ratio (INR) greater than 1.5.\n* American Society of Anesthesiologists (ASA) physical status of 3 or higher.\n* chronic kidney disease.'}, 'identificationModule': {'nctId': 'NCT07392034', 'briefTitle': 'Efficacy of Tranexamic Acid Reducing Blood Loss During Maxillofacial Trauma Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Nishtar Medical University'}, 'officialTitle': 'Efficacy of Tranexamic Acid Reducing Blood Loss During Maxillofacial Trauma Surgery', 'orgStudyIdInfo': {'id': '12076/NID'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Trenexamic acid group', 'description': 'Thirty minutes prior to surgery, the intervention group received intravenous trenexamic acid at a dose of 20 mg/kg.', 'interventionNames': ['Drug: Tranexamic Acid (TXA)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Thirty minutes prior to surgery, the placebo group received 20 mL of normal saline.', 'interventionNames': ['Drug: Normal saline']}], 'interventions': [{'name': 'Tranexamic Acid (TXA)', 'type': 'DRUG', 'description': 'Thirty minutes prior to surgery, the intervention group receive intravenous , single dose of tranexamic acid of 20 mg/kg.', 'armGroupLabels': ['Trenexamic acid group']}, {'name': 'Normal saline', 'type': 'DRUG', 'description': 'Thirty minutes prior to surgery, the placebo group received single dose of 20 mL of normal saline.', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66000', 'city': 'Multan', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Nishtar institute of dentistry, Multan', 'geoPoint': {'lat': 30.19679, 'lon': 71.47824}}], 'overallOfficials': [{'name': 'Dr. Saima Munir, FCPS (OMFS)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nishtar institute of dentistry, Multan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nishtar Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Postgraduate resident Oral and maxillofacial surgery', 'investigatorFullName': 'Shakir Hussain', 'investigatorAffiliation': 'Nishtar Medical University'}}}}