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ToolsAl Sulaiman, Khalid A., Al-Ramahi, Ghassan, Aljuhani, Ohoud, Al-Joudi, Khuloud, Alhujayri, Abdulaziz K., Al-Shomer, Feras, Silas, Johanna, Al Dabbagh, Tarek, Al Harbi, Shmeylan, AlDekhayel, Salah, Eldali, Ahmed, Alqahtani, Rahaf, Vishwakarma, Ramesh and Al-Dorzi, Hasan M. (2024) Comparison of the safety and efficacy for different regimens of pharmaco-prophylaxis among severely burned patients: a randomized controlled trial. European Journal of Trauma and Emergency Surgery, 50 (2). pp. 567-579. ISSN 1863-9933
Full text not available from this repository. (Request a copy)Abstract
Purpose: Venous 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. Methods: A 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. Results: Twenty 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. Conclusion: The 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 number: NCT05237726.
| Item Type: | Article |
|---|---|
| Additional Information: | The datasets used and/or analyzed during the current study are available from the corresponding author upon reasonable request. We would like to thank all the investigators who participated in this project from the Saudi Critical Care Pharmacy Research (SCAPE) Platform. |
| Uncontrolled Keywords: | bleeding,burn,enoxaparin,intensive care,mortality,thermal injury,thrombosis,unfractionated heparin,vte pharmaco-prophylaxis,surgery,emergency medicine,orthopedics and sports medicine,critical care and intensive care medicine ,/dk/atira/pure/subjectarea/asjc/2700/2746 |
| Faculty \ School: | Faculty of Medicine and Health Sciences > Norwich Medical School |
| UEA Research Groups: | Faculty of Medicine and Health Sciences > Research Centres > Public Health Faculty of Medicine and Health Sciences > Research Centres > Population Health (former - to 2025) |
| Related URLs: | |
| Depositing User: | LivePure Connector |
| Date Deposited: | 14 Apr 2026 13:34 |
| Last Modified: | 14 Apr 2026 13:34 |
| URI: | https://ueaeprints.uea.ac.uk/id/eprint/102773 |
| DOI: | 10.1007/s00068-024-02443-9 |
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