Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2026-02-24 @ 8:27 AM
Study NCT ID:
NCT04031859
Status:
COMPLETED
Last Update Posted:
2020-02-25
First Post:
2019-07-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk Stratification Procedure for Thromboembolism Prophylaxis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054556', 'term': 'Venous Thromboembolism'}], 'ancestors': [{'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}], 'ancestors': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 242}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-07-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-23', 'studyFirstSubmitDate': '2019-07-22', 'studyFirstSubmitQcDate': '2019-07-22', 'lastUpdatePostDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Venous thromboembolism (VTE) complications', 'timeFrame': '35 days post total Knee Replacement surgery', 'description': 'Deep vein thrombosis, pulmonary embolism, sudden death'}, {'measure': 'Bleeding events', 'timeFrame': '35 days post total Knee Replacement surgery', 'description': 'Major or minor bleeding will be recorded'}], 'secondaryOutcomes': [{'measure': 'Surgical site infection', 'timeFrame': '35 days post total Knee Replacement surgery', 'description': 'Surgical site infection post operation'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Total Knee Replacement', 'Venous thromboembolism (VTE)', 'Risk Stratification'], 'conditions': ['Total Knee Replacement Surgeries']}, 'referencesModule': {'references': [{'pmid': '33029262', 'type': 'DERIVED', 'citation': 'Alameri MA, Syed Sulaiman SA, Ashour AM, Al-Saati MF. Venous thromboembolism prevention protocol for adapting prophylaxis recommendations to the potential risk post total knee replacement: a randomized controlled trial. Pharm Pract (Granada). 2020 Jul-Sep;18(3):2025. doi: 10.18549/PharmPract.2020.3.2025. Epub 2020 Sep 22.'}]}, 'descriptionModule': {'briefSummary': 'The main objective for this study is validation for the proposed risk stratification tool, by evaluating the clinical outcomes for its use post TKR Surgeries. For this objective, the design that is used is Randomized Trial.', 'detailedDescription': 'All patients that will have total knee replacement, in a given period of time in both medical centers; Prince Sultan Military Medical City (PSMMC) and King Abd Allah University Hospital (KAAUH) in Princess Noura University, will be randomly separated into 2 groups; in the first group (A): Venous thromboembolism (VTE) risk stratification tool (which is prepared by a clinical pharmacist) will be applied to choose the tailored extended VTE prophylactic agent. While in the second group (B), the risk stratification tool will not be used, rather it will follow the routine hospital protocol for choosing the VTE prophylactic agent, which is Caprini: a standard validated model. Then each group of patients will be followed till 35 days post-operation, during which all VTE or bleeding events should be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or Female patients who are planned for elective TKR surgery (primary only).\n2. Agreed to sign the Informed consent form (ICF).\n3. Patients aged older than 18 years.\n\nExclusion Criteria:\n\n1. Patients receiving anticoagulant for treatment.\n2. Patients with a history of DVT or PE were excluded from the study due to the marked increase in the risk of recurrent VTE compared to the general risk of (7% vs. 0.1%); (Fahrni, 2015).\n3. Patients with renal or hepatic failure, renal failure is defined as end-stage kidney disease (on dialysis); hepatic failure is defined as complete liver cirrhosis.\n4. Pregnant woman.\n5. Revision surgeries.'}, 'identificationModule': {'nctId': 'NCT04031859', 'briefTitle': 'Risk Stratification Procedure for Thromboembolism Prophylaxis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ministry of Health, Saudi Arabia'}, 'officialTitle': 'The Effectiveness of a Risk Stratification Procedure for Thromboembolism Prophylaxis After Total Knee Replacement Surgeries', 'orgStudyIdInfo': {'id': 'PSMMC & KAAUH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'In this group a VTE risk stratification procedure will be used', 'interventionNames': ['Drug: acetylsalicylic acid']}, {'type': 'NO_INTERVENTION', 'label': 'Group B', 'description': 'In this group a standard VTE risk stratification procedure will be used (Caprini VTE risk assessment tool)'}], 'interventions': [{'name': 'acetylsalicylic acid', 'type': 'DRUG', 'otherNames': ['VTE risk stratification procedure'], 'description': "It's a VTE risk stratification tool or procedure that will be used after total knee replacement (TKR) to help surgeons in choosing the tailored VTE prophylaxis according to patients' specific VTE risk, this tool will stratify the TKR-patient in one of three risk-groups: Low high risk who will be prescribed Aspirin upon hospital discharge as extended VTE prophylaxis post TKR surgery, or moderate high risk group who will be prescribed oral anti coagulant (like rivaroxaban) as extended prophylaxis, and the last group is very high risk group who will be prescribed parenteral anticoagulant ( like Enoxaparin) plus compression devices.", 'armGroupLabels': ['Group A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00966', 'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'Prince Sultan Medical Military City', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}], 'overallOfficials': [{'name': 'Mariam Alameri, MSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universiti Sains Malaysia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ministry of Health, Saudi Arabia', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Prince Sultan Military College of Health Sciences', 'class': 'OTHER'}, {'name': 'Universiti Sains Malaysia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Pharmacist', 'investigatorFullName': 'Mariam Ahmad Alameri, Clinical Pharmacist', 'investigatorAffiliation': 'Ministry of Health, Saudi Arabia'}}}}