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

King Abdullah International Medical Research Center

Status: Completed

Conditions: Burns

Treatments: Drug: Unfractionated heparin 5000 U q8 hours; Drug: Enoxaparin 40 mg q24 hours; Drug: Enoxaparin 30 mg q12 hours

Study type: Interventional

Funder types: Other

Identifiers

NCT05237726

RC18-400-R

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 3 patient groups

Unfractionated Heparin (UFH) 5000 U q8 hours

Active Comparator group

Description:

Severely burn injuries (BSA≥20%) will receive Unfractionated Heparin (UFH) 5000 U q8 hours as pharmacological VTE prophylaxis

Treatment:

Drug: Unfractionated heparin 5000 U q8 hours

Enoxaparin 40 mg q24 hours

Active Comparator group

Description:

Severely burn injuries (BSA≥20%) will receive Enoxaparin 40 mg q24 hours as pharmacological VTE prophylaxis

Treatment:

Drug: Enoxaparin 40 mg q24 hours

Enoxaparin 30 mg q12 hours

Active Comparator group

Description:

Severely burn injuries (BSA≥20%) will receive Enoxaparin 30 mg q12 hours as pharmacological VTE prophylaxis

Treatment:

Drug: Enoxaparin 30 mg q12 hours