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Direct Oral Anticoagulant — Direct Thrombin Inhibitor

Dabigatran (Orthopaedic VTE Prophylaxis)

Brand names: Pradaxa

Dabigatran etexilate is an oral direct thrombin inhibitor licensed for prevention of venous thromboembolism after elective hip or knee replacement surgery. This page covers its use as orthopaedic VTE prophylaxis.

Dosing — being independently re-sourced

ClinCalc Pro is rebuilding its dose data from primary open sources — the manufacturer SmPC (eMC), the WHO Model Formulary and other official references — under clinician review. This drug's structured dose is not yet published here. Confirm all doses against the product SmPC and your local formulary before prescribing.

Clinical monograph

How it works

It is a prodrug converted to dabigatran, which directly and reversibly inhibits thrombin (factor IIa), preventing conversion of fibrinogen to fibrin and thrombus formation.

Prescribing in practice

  • Bleeding is the principal risk — it is contraindicated in active clinically significant bleeding and severe renal impairment, and renal function must be assessed before and during use because clearance is largely renal.
  • Idarucizumab is a specific reversal agent for emergency bleeding or urgent surgery, and concomitant strong P-glycoprotein inhibitors or other antithrombotics substantially increase bleeding risk.
  • Capsules must not be removed from the blister or crushed as this raises absorption and bleeding risk, and dosing/frequency follow the surgical prophylaxis schedule in the SPC with the first dose timed after haemostasis.

Monitoring

Routine coagulation monitoring is not required, but check renal function periodically and before procedures and observe for signs of bleeding.

Counselling the patient

  • Report unusual bruising, bleeding that will not stop, black stools or blood in urine.
  • Swallow the capsule whole and keep it in its original blister pack until use; do not crush or open it.
  • Tell any clinician or dentist you take an anticoagulant before procedures.

Evidence & guidelines

Dabigatran for VTE prophylaxis after major orthopaedic surgery is supported by the RE-MODEL and RE-NOVATE trial programme and is included in NICE VTE prevention guidance.

Reference: RE-NOVATE Trial (Lancet 2007); RE-MODEL Trial (J Thromb Haemost 2007); NICE NG89; SPC Pradaxa; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.