Two Weeks of Low Molecular Weight Heparin for Distal Vein Thrombosis

NCT ID: NCT01252420

Last Updated: 2010-12-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2014-11-30

Brief Summary

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.

Detailed Description

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.

There 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.

The 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.

In 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.

Conditions

Venous Thrombosis; Pulmonary Embolism

Keywords

Distal Vein Thrombosis; Proximal Vein Thrombosis; Pulmonary Embolism; Post-thrombotic syndrome; Limited duration treatment

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Enoxaparin

1.5mg/kg daily for 2 weeks

Intervention Type: DRUG

Other Intervention Names

Clexane

Eligibility Criteria

Inclusion Criteria

• 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)
• Absence of symptomatic pulmonary embolism

Exclusion Criteria

• DVT involving trifurcation or more proximal leg veins on imaging
• Prior DVT
• Active malignancy ie present at time of diagnosis, or on treatment, or treatment completed within 3 months
• Ongoing risk factors for propagation e.g. immobility (>50% of day in bed or ≥72 hours), plaster cast or non-weight bearing
• Other indication for therapeutic anticoagulation (e.g. AF)
• Active gastro-oesophageal ulceration or bleeding
• Other high risk for bleeding (e.g. recent neurosurgery, vascular retinopathy, coagulopathy)
• Platelet count <80 x 109/L
• Renal impairment (CrCl <30ml/min) • Pregnancy or lactation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Southern Health, Victoria

UNKNOWN

Sponsor Role: collaborator

Eastern Health, Victoria

UNKNOWN

Sponsor Role: collaborator

Royal Adelaide Hospital, Adelaide

UNKNOWN

Sponsor Role: collaborator

Prince of Wales Hospital, Sydney

OTHER_GOV

Sponsor Role: collaborator

Christchurch Hospital, NZ

UNKNOWN

Sponsor Role: collaborator

Auckland City Hospital

OTHER_GOV

Sponsor Role: collaborator

North Shore Hospital, New Zealand

OTHER

Sponsor Role: collaborator

Middlemore Hospital, New Zealand

OTHER

Sponsor Role: collaborator

Monash Medical Centre

OTHER

Sponsor Role: lead

Responsible Party

Monash Medical Centre, Southern Health

Principal Investigators

Huyen Tran, MBBs(Hons), MClin Epidem

Role: PRINCIPAL_INVESTIGATOR

Monash Medical Centre

Locations

Prince of Wales Hospital

Sydney, New South Wales, Australia

Site Status: NOT_YET_RECRUITING

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Site Status: NOT_YET_RECRUITING

Monash Medical Centre, Southern Health

Melbourne, Victoria, Australia

Site Status: RECRUITING

Christchurch Hospital

Christchurch, Canterbury, New Zealand

Site Status: NOT_YET_RECRUITING

Countries

Australia; New Zealand

Facility Contacts

Tim Brighton, MBBs, MD

Role: primary

Simon McRae, MBBs, BMedSci

Role: primary

Eileen Merriman, MBChB

Role: primary

Huyen Tran, MBBS, BClinEpi

Role: backup

Mark Smith, MBChB

Role: primary

References

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.

Reference Type: DERIVED

PMID: 34530387 (View on PubMed)

Other Identifiers

DDVTANZ

Identifier Type: -

Identifier Source: org_study_id