• Eur J Trauma Emerg Surg · Apr 2024

    Randomized Controlled Trial Comparative Study

    Comparison of the safety and efficacy for different regimens of pharmaco-prophylaxis among severely burned patients: a randomized controlled trial.

    • Khalid A Al Sulaiman, Ghassan Al-Ramahi, Ohoud Aljuhani, Khuloud Al-Joudi, Abdulaziz K Alhujayri, Feras Al-Shomer, Johanna Silas, Tarek Al Dabbagh, Shmeylan Al Harbi, Salah AlDekhayel, Ahmed Eldali, Rahaf Alqahtani, Ramesh Vishwakarma, and Hasan M Al-Dorzi.
    • Pharmaceutical Care Department, King Abdulaziz Medical City (KAMC) - Ministry of National Guard Health Affairs (MNGHA), King Abdullah International Medical Research Center/King Saud bin Abdulaziz University for Health Sciences, PO Box 22490, 11426, Riyadh, Saudi Arabia. alsulaimankh@hotmail.com.
    • Eur J Trauma Emerg Surg. 2024 Apr 1; 50 (2): 567579567-579.

    PurposeVenous thromboembolism (VTE) is a common complication in critically ill patients, including severe burn cases. Burn patients respond differently to medications due to pharmacokinetic changes. This study aims to assess the feasibility and safety of different VTE pharmaco-prophylaxis in patients admitted to the ICU with severe burns.MethodsA pilot, open-label randomized controlled trial was conducted on ICU patients with severe burns (BSA ≥ 20%). By using block randomization, patients were allocated to receive high-dose enoxaparin 30 mg q12hours (E30q12), standard-dose enoxaparin 40 mg q24hours (E40q24), or unfractionated heparin (UFH) 5000 Units q8hours. In this study, the primary outcomes assessed were the recruitment and consent rates, as well as bleeding or hematoma at both the donor and graft site. Additionally, secondary measures were evaluated to provide further insights.ResultsTwenty adult patients out of 114 screened were enrolled and received E30q12 (40%), E40q24 (30%), and UFH (30%). The recruitment rate was one patient per month with a 100% consent rate. Donor site bleeding occurred in one patient (16.7%) in the UFH group. On the other hand, graft site bleeding was only reported in one patient (12.5%) who received E30q12. Major bleeding happened in two patients, one in E30q12 and one in the UFH group. Five patients (25.0%) had minor bleeding; two patients (25.0%) received E30q12, two patients E40q24, and one patient UFH. RBC transfusion was needed in four patients, two on E30q12 and two on UFH. Only one patient had VTE, while four patients died in the hospital.ConclusionThe study observed a low recruitment rate but a high consent rate. Furthermore, there were no major safety concerns identified with any of the three pharmacologic prophylaxis regimens that were evaluated.Trial Registration NumberNCT05237726.© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.

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