Clinical trial NCT05237726: Efficacy and Safety for Different Regimen of VTE Pharmacoprophylaxis Among Severely Burn Patients
Official title: Comparison of the Efficacy and Safety for Different Regimen of Venous Thromboembolism Pharmacoprophylaxis Among Severely Burn Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burns
Keywords: Severely burn
BSA≥20%
Enoxaparin
Unfractionated Heparin
VTE
Bleeding
Lead sponsor: King Abdullah International Medical Research Center
Sponsor class: OTHER
First posted: 2022-02-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three groups randomized to receive DVT prophylaxis either enoxaparin 30 mg every 12 hours, enoxaparin 40 mg once daily and unfractionated heparin 5000 units every 8 hours
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Incidence of bleeding events (major and minor)
timeFrame: Through study completion, an average of 2 years
measure: 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
measure: Recruitment and consent rates
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
measure: Target anti Xa factor for enoxaparin or unfractionated heparin in severely burn patients.
timeFrame: Through study completion, an average of 2 years
measure: Incidence of Heparin induced thrombocytopenia (HIT).
timeFrame: Through study completion, an average of 2 years
measure: Number of days that patients stay in hospital
timeFrame: Through study completion, an average of 2 years
measure: Number of patients died within intensive care unit stay
timeFrame: Through study completion, an average of 2 years
measure: Incidence of VTE events (Symptomatic)
timeFrame: Through study completion, an average of 2 years
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Abdulaziz Medical City
Study officials:
References: