CompletedNot Applicable

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

Saudi Arabia20 participantsStarted 2020-04-05

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Incidence of bleeding events (major and minor)

Timeframe: Through study completion, an average of 2 years

Adverse effects in surgical outcomes (i.e. Graft loss, donor site morbidity, requirement of hemostatic intervention).

Timeframe: Through study completion, an average of 2 years

Recruitment and consent rates

Timeframe: Through study completion, an average of 2 years

Trial details

NCT IDNCT05237726

SponsorKing Abdullah International Medical Research Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-02-28

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