Secondary Prevention of VTE in Patients With Cancer and Catheter-Related Upper Extremity Deep Vein Thrombosis

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Hospital Research Institute

About this trial

This trial seeks to evaluate a management strategy after the acute treatment duration (≥ 3 months of therapeutic anticoagulation) for patients with cancer and catheter-related upper extremity deep vein thrombosis (DVT).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Anticoagulation Therapy

    Drug

    Patients will be enrolled after at least 3 months of therapeutic anticoagulation for an acute catheter-related upper extremity DVT while they are treated with therapeutic anticoagulation as standard of care. After enrollment, patients will be managed with prophylactic dose of anticoagulation as long as either a CVC or active cancer is present. If cancer goes into remission, at the time of CVC removal, anticoagulation will be stopped, but patients will continue to be followed until the end of the study at 6 months.

Treatment groups

330 Participants
are divided into 1 treatment group
Group A: ApixabanExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Venous Thromboembolism (VTE) Rate

The rates of symptomatic, objectively confirmed new or recurrent major VTE (proximal upper or lower extremity DVT, segmental or larger pulmonary embolism (PE)) with corresponding 95% Confidence Interval (CI) at 6 months.

Time frame
6 months

Secondary outcomes

1

Major Venous Thromboembolism (VTE) and Major bleeding Rate

Rates of new/recurrent symptomatic major VTE and major bleeding at 3 months.

Time frame
3 months
2

New/recurrent symptomatic catheter-related upper extremity Deep Vein Thrombosis (DVT).

New/recurrent symptomatic catheter-related upper extremity DVT.

Time frame
3 months and 6 months
3

New incidental Venous Thromboembolism (VTE)

New incidental VTE (PE or upper or lower extremity DVT), defined as VTE diagnosed on imaging studies obtained not for concern of VTE, such as cancer staging scans.

Time frame
3 months and 6 months
4

New Deep Vein Thrombosis (DVT)

New/recurrent any distal upper or lower extremity DVT or subsegmental PE.

Time frame
3 months and 6 months

Other outcomes

Sponsors and contacts

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