A Study of Dabigatran Etexilate as Primary Treatment of Malignancy Associated Venous Thromboembolism
Status:
Recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
Summary
This trial aims at determining if dabigatran is effective in the treatment of malignancy
associated VTE. Tolerance and safety of dabigatran will also be assessed.
This is a single armed trial of dabigatran in patients with malignancy associated VTE.
The target recruitment is 99 consecutive patients with active malignancy and newly diagnosed
VTE (deep vein thrombosis and/or pulmonary embolism) in Queen Mary Hospital.
Tinzaparin 175 iu/kg daily will be started after the diagnosis of VTE is confirmed (duplex
Doppler ultrasonography for deep vein thrombosis, and computed tomography for pulmonary
embolism), and a written consent is obtained. Patients will be switched to dabigatran 150mg
twice daily from day 6 onwards. The first dose of dabigatran will be given within 2 hours
before the time that the next dose of tinzaparin would have been due. Anticoagulation will be
continued as long as malignancy is active. If patients achieve a complete remission of their
underlying malignancies, dabigatran will be continued for 6 months further.