Efficacy and Safety for Different Regimen of VTE Pharmacoprophylaxis Among Severely Burn Patients

Comparison of the Efficacy and Safety for Different Regimen of Venous Thromboembolism Pharmacoprophylaxis Among Severely Burn Patients

This study aims to assess the feasibility and safety of VTE prophylaxis for 3 modality regimens (Unfractionated heparin 5000 U SQ q8 hours, Enoxaparin 40 mg SQ q24 hours or Enoxaparin 30 mg SQ q12 hours) in adult patients (≥18 y/o) with severely burn injuries (BSA≥20%) by measuring the bleeding incidence and VTE events.

This is a pilot , randomized control trial-Open label, prospective trial in tertiary academic hospitals for patient admitted to burn ICU for at least 24 hours of injury or transferred from other hospital(s) within 7 days of injury. Each patient admitted meets the inclusion criteria will be randomize by block randomization to either receive heparin 5000 units S.C. TID, enoxaparin 40 mg S.C. OD, or Enoxaparin 30 mg S.C. BID. VTE prophylaxis should be started within 36 hours of injury, if the patient is transferred from another facility, VTE prophylaxis should be started immediately unless contraindicated. All patients should undergo diagnostic ultrasound at baseline ( before starting the prophylaxis) to assess any presence of DVT and as clinically indicated for clinical suspicion for VTE thereafter until discharge, an urgent spiral CTA chest will be requested on clinical suspicion for PE. Anti Xa factor will be monitored at day 3, and weekly thereafter until discharge unless there is active bleeding or high clinical suspicion for bleeding. Will follow-up patient until discharge from ICU, developed VTE requiring treatment (switch to treatment dose), developed HIT or death.

Inclusion Criteria:

• Burn ICU admitted adult patients, age ≥ 18 years old.
• Body Mass Index of 18.5 to < 40 kg/m2.
• TBSA of 20% or more.

Exclusion Criteria:

• VTE history.
• Death within 24 hours of injury.
• Burn injuries combined with trauma requiring withholding pharmacoprophylaxis more than 48 hours.
• Coagulopathy (INR > 1.7, PTT> 2 times upper normal limit, platelet < 50k mm3)
• Patient with positive baseline US for VTE.
• Heparin induced thrombocytopenia (HIT).
• Active bleeding.
• Patients with CrCl of 30 ml/min or less.
• Patients using anticoagulation treatment dose for other indications.