Direct Oral Anticoagulant — Direct Thrombin Inhibitor Pregnancy: Avoid — no human data; rat studies showed skeletal malformations

Dabigatran (Orthopaedic VTE Prophylaxis)

Brand names: Pradaxa

Adult dose

Dose: 220 mg once daily (half dose 110 mg on Day 1 only, 1–4 hours post-op); 150 mg for patients ≥75 years

Route: Oral

Frequency: Once daily

Max: 220 mg once daily

THR: 28–35 days. TKR: 10 days. Start 1–4 hours post-surgery with half dose (110 mg). Must be swallowed whole — do not open capsule (tartaric acid pellets are acidic, damage oesophageal mucosa if broken). Take with water.

Paediatric dose

Route:

Not licensed for paediatric orthopaedic VTE prophylaxis — seek specialist opinion

Dose adjustments

Renal

eGFR <30 mL/min: avoid. eGFR 30–50 mL/min: consider 150 mg once daily. Check eGFR before each course

Hepatic

Avoid in severe hepatic impairment

Clinical pearls

RE-NOVATE trial (Lancet 2007): dabigatran 220 mg non-inferior to enoxaparin 40 mg for VTE prevention in THR over 28–35 days
RE-MODEL trial: dabigatran non-inferior to enoxaparin for TKR VTE prophylaxis — 10 days
Dyspepsia management: most common reason for discontinuation — take with food, use PPI if necessary. Do NOT open capsules
Idarucizumab (Praxbind) 5 g IV: specific reversal agent for dabigatran; binds dabigatran with 350× affinity of thrombin; available in UK for emergency reversal
80% renally cleared — most renally dependent DOAC; check creatinine before each surgical episode; avoid in eGFR <30

Contraindications

eGFR <30 mL/min
Active significant bleeding
Prosthetic heart valves (valvular AF — RE-ALIGN trial: increased strokes)
Hepatic impairment with coagulopathy
Concurrent P-gp inhibitors (systemic ketoconazole, ciclosporin, dronedarone)

Side effects

Bleeding
Dyspepsia — most common; due to tartaric acid formulation (acid microenvironment for absorption)
Wound complications
Anaemia
Elevated liver enzymes

Interactions

P-gp inhibitors (dronedarone, systemic ketoconazole, ciclosporin) — increase dabigatran levels; avoid
P-gp inducers (rifampicin, carbamazepine, St John's Wort) — reduce dabigatran levels; avoid
Amiodarone — modest increase in dabigatran; monitor

Monitoring

Renal function (eGFR) before and during treatment
LFTs baseline
Signs of bleeding
GI symptoms — dyspepsia

Reference: BNFc; BNF 90; RE-NOVATE Trial (Lancet 2007); RE-MODEL Trial (J Thromb Haemost 2007); NICE NG89; SPC Pradaxa. Verify against your local formulary and the latest BNF before prescribing.

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways