Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT01252420
Status:
UNKNOWN
Last Update Posted:
2010-12-06
First Post:
2010-07-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Two Weeks of Low Molecular Weight Heparin for Distal Vein Thrombosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D011655', 'term': 'Pulmonary Embolism'}, {'id': 'D054070', 'term': 'Postthrombotic Syndrome'}], 'ancestors': [{'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004617', 'term': 'Embolism'}, {'id': 'D014689', 'term': 'Venous Insufficiency'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017984', 'term': 'Enoxaparin'}], 'ancestors': [{'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 330}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2014-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-12-03', 'studyFirstSubmitDate': '2010-07-20', 'studyFirstSubmitQcDate': '2010-12-02', 'lastUpdatePostDateStruct': {'date': '2010-12-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptomatic recurrence of venous thrombosis (DVT, non fatal and fatal pulmonary embolism) within 3 months.', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Asymptomatic proximal thrombus extension at 2 weeks', 'timeFrame': '2 weeks'}, {'measure': 'Time course of symptom resolution and the proportion of patients with complete resolution at two weeks.', 'timeFrame': '2 weeks', 'description': 'Time course of symptom resolution including time to complete resolution of symptoms, and the proportion of patients with complete resolution at two weeks.'}, {'measure': 'All-cause mortality', 'timeFrame': '3 months'}, {'measure': 'Post-thrombotic syndrome', 'timeFrame': '6 months'}, {'measure': 'Predictors of recurrent or progressive DVT or new PE', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Distal Vein Thrombosis', 'Proximal Vein Thrombosis', 'Pulmonary Embolism', 'Post-thrombotic syndrome', 'Limited duration treatment'], 'conditions': ['Venous Thrombosis', 'Pulmonary Embolism']}, 'referencesModule': {'references': [{'pmid': '34530387', 'type': 'DERIVED', 'citation': 'Merriman E, Chunilal S, Brighton T, Chen V, McRae S, Ockelford P, Curnow J, Tran H, Chong B, Smith M, Royle G, Crowther H, Slocombe A, Tran H. Two Weeks of Low Molecular Weight Heparin for Isolated Symptomatic Distal Vein Thrombosis (TWISTER study). Thromb Res. 2021 Nov;207:33-39. doi: 10.1016/j.thromres.2021.09.004. Epub 2021 Sep 11.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether a limited duration of treatment (two weeks of low molecular weight treatment) is a safe and effective treatment for distal deep vein thrombosis of the lower limb.', 'detailedDescription': 'Approximately 50% of symptomatic episodes of deep vein thrombosis (DVT) will be confined to the calf veins (distal DVT). The proportion of distal DVT that propagate to the proximal veins, increasing the risk of pulmonary embolism, is not known. The best treatment of isolated distal DVT is therefore controversial and options include no treatment, follow-up scanning and treatment of only those patients with thrombus propagating to proximal veins, and full anticoagulation for periods ranging from 2 weeks to 3 months.\n\nThere is good evidence that the 3-month thromboembolic risk in patients with a negative CUS that is limited to the proximal veins is low, in the order of 1%. Previous studies have demonstrated that patients treated with a short period of anticoagulation (4-6 weeks) have a low risk of developing recurrent DVT or PE. In addition, the specificity of CUS for distal DVT is lower than that for proximal DVT, increasing the proportion of false positive findings, making it likely that a proportion of patients diagnosed with distal DVT are treated unnecessarily, with the attendant risks of major and fatal haemorrhage.\n\nThe need for anticoagulation of patients with distal DVT to prevent recurrent DVT is therefore uncertain, however a survey of current practice suggested that most patients with this condition currently receive antithrombotic therapy. The impact of anticoagulation on initial patient symptoms, and the subsequent risk of the post-thrombotic syndrome are also unclear, and may be a possible alternative justification for antithrombotic therapy.\n\nIn this proposed multicentre, prospective, cohort study, we plan to determine if a shorter duration of anticoagulation (minimum 2 weeks) is a safe and effective treatment for isolated distal vein thrombosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 years or older with acute symptomatic provoked or unprovoked distal vein thrombosis (axial or muscular veins but not involving trifurcation or distal popliteal vein)\n* Absence of symptomatic pulmonary embolism\n\nExclusion Criteria:\n\n* DVT involving trifurcation or more proximal leg veins on imaging\n* Prior DVT\n* Active malignancy ie present at time of diagnosis, or on treatment, or treatment completed within 3 months\n* Ongoing risk factors for propagation e.g. immobility (\\>50% of day in bed or ≥72 hours), plaster cast or non-weight bearing\n* Other indication for therapeutic anticoagulation (e.g. AF)\n* Active gastro-oesophageal ulceration or bleeding\n* Other high risk for bleeding (e.g. recent neurosurgery, vascular retinopathy, coagulopathy)\n* Platelet count \\<80 x 109/L\n* Renal impairment (CrCl \\<30ml/min) • Pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT01252420', 'acronym': 'TWISTER', 'briefTitle': 'Two Weeks of Low Molecular Weight Heparin for Distal Vein Thrombosis', 'organization': {'class': 'OTHER', 'fullName': 'Monash Medical Centre'}, 'officialTitle': 'Two Weeks of Low Molecular Weight Heparin for Distal Vein Thrombosis (TWISTER)', 'orgStudyIdInfo': {'id': 'DDVTANZ'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Enoxaparin', 'type': 'DRUG', 'otherNames': ['Clexane'], 'description': '1.5mg/kg daily for 2 weeks'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2031', 'city': 'Sydney', 'state': 'New South Wales', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Tim Brighton, MBBs, MD', 'role': 'CONTACT', 'email': 'Tim.Brighton@SESIAHS.HEALTH.NSW.GOV.AU', 'phone': '+61293829013'}, {'name': 'Tim Brighton, MBBs, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Simon McRae, MBBs, BMedSci', 'role': 'CONTACT', 'phone': '+61 448882279'}, {'name': 'Simon McRae, MBBs, BMedSci', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Royal Adelaide Hospital', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '3168', 'city': 'Melbourne', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Eileen Merriman, MBChB', 'role': 'CONTACT', 'email': 'eileen.merriman@southernhealth.org.au', 'phone': '+61 450011998'}, {'name': 'Huyen Tran, MBBS, BClinEpi', 'role': 'CONTACT', 'email': 'huyen.tran@southernhealth.org.au', 'phone': '+61 408780785'}, {'name': 'Huyen Tran, MBBs, MClinEp', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Eileen Merriman, MBChB', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sanjeev Chunilal, MBChB', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Monash Medical Centre, Southern Health', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '8011', 'city': 'Christchurch', 'state': 'Canterbury', 'status': 'NOT_YET_RECRUITING', 'country': 'New Zealand', 'contacts': [{'name': 'Mark Smith, MBChB', 'role': 'CONTACT', 'email': 'mark.smith@cdhb.govt.nz', 'phone': '+64 3 3640640'}, {'name': 'Mark Smith, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Christchurch Hospital', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}], 'overallOfficials': [{'name': 'Huyen Tran, MBBs(Hons), MClin Epidem', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Monash Medical Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Monash Medical Centre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Southern Health, Victoria', 'class': 'UNKNOWN'}, {'name': 'Eastern Health, Victoria', 'class': 'UNKNOWN'}, {'name': 'Royal Adelaide Hospital, Adelaide', 'class': 'UNKNOWN'}, {'name': 'Prince of Wales Hospital, Sydney', 'class': 'OTHER_GOV'}, {'name': 'Christchurch Hospital, NZ', 'class': 'UNKNOWN'}, {'name': 'Auckland City Hospital', 'class': 'OTHER_GOV'}, {'name': 'North Shore Hospital, New Zealand', 'class': 'OTHER'}, {'name': 'Middlemore Hospital, New Zealand', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Huyen Tran', 'oldOrganization': 'Monash Medical Centre, Southern Health'}}}}