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

• Status: Recruiting
• Trial end date: 2022-03-31
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to assess the safety and efficacy 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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: King Abdullah International Medical Research Center
• Treatments: Calcium heparin; Enoxaparin; Enoxaparin sodium; Heparin

Criteria

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.