PMID- 38240791 OWN - NLM STAT- MEDLINE DCOM- 20240423 LR - 20240508 IS - 1863-9941 (Electronic) IS - 1863-9933 (Linking) VI - 50 IP - 2 DP - 2024 Apr TI - Comparison of the safety and efficacy for different regimens of pharmaco-prophylaxis among severely burned patients: a randomized controlled trial. PG - 567-579 LID - 10.1007/s00068-024-02443-9 [doi] AB - 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. CI - (c) 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany. FAU - Al Sulaiman, Khalid A AU - Al Sulaiman KA AUID- ORCID: 0000-0002-5547-2043 AD - 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. AD - College of Pharmacy, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia. alsulaimankh@hotmail.com. AD - King Abdullah International Medical Research Center-King Saud Bin Abdulaziz University for Health Sciences, Ministry of National Guard - Health Affairs, Riyadh, Saudi Arabia. alsulaimankh@hotmail.com. AD - Saudi Critical Care Pharmacy Research (SCAPE) Platform, Riyadh, Saudi Arabia. alsulaimankh@hotmail.com. FAU - Al-Ramahi, Ghassan AU - Al-Ramahi G AD - Plastic Surgery Department, King Saud Medical City, Riyadh, Saudi Arabia. FAU - Aljuhani, Ohoud AU - Aljuhani O AD - Department of Pharmacy Practice, Faculty of Pharmacy, King Abdulaziz University, Jeddah, Saudi Arabia. FAU - Al-Joudi, Khuloud AU - Al-Joudi K AD - 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. AD - College of Pharmacy, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia. AD - King Abdullah International Medical Research Center-King Saud Bin Abdulaziz University for Health Sciences, Ministry of National Guard - Health Affairs, Riyadh, Saudi Arabia. FAU - Alhujayri, Abdulaziz K AU - Alhujayri AK AD - King Abdullah International Medical Research Center-King Saud Bin Abdulaziz University for Health Sciences, Ministry of National Guard - Health Affairs, Riyadh, Saudi Arabia. AD - Plastic Surgery Division, Department of Surgery, Ministry of National Guard - Health Affairs, Riyadh, Saudi Arabia. FAU - Al-Shomer, Feras AU - Al-Shomer F AD - King Abdullah International Medical Research Center-King Saud Bin Abdulaziz University for Health Sciences, Ministry of National Guard - Health Affairs, Riyadh, Saudi Arabia. AD - Plastic Surgery Division, Department of Surgery, Ministry of National Guard - Health Affairs, Riyadh, Saudi Arabia. FAU - Silas, Johanna AU - Silas J AD - King Abdullah International Medical Research Center-King Saud Bin Abdulaziz University for Health Sciences, Ministry of National Guard - Health Affairs, Riyadh, Saudi Arabia. AD - Nursing Department, King Abdulaziz Medical City, Riyadh, Saudi Arabia. FAU - Al Dabbagh, Tarek AU - Al Dabbagh T AD - King Abdullah International Medical Research Center-King Saud Bin Abdulaziz University for Health Sciences, Ministry of National Guard - Health Affairs, Riyadh, Saudi Arabia. AD - Intensive Care Department, King Abdulaziz Medical City, Riyadh, Saudi Arabia. FAU - Al Harbi, Shmeylan AU - Al Harbi S AD - 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. AD - College of Pharmacy, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia. AD - King Abdullah International Medical Research Center-King Saud Bin Abdulaziz University for Health Sciences, Ministry of National Guard - Health Affairs, Riyadh, Saudi Arabia. FAU - AlDekhayel, Salah AU - AlDekhayel S AD - Plastic Surgery Division, Department of Surgery, Ministry of National Guard - Health Affairs, Riyadh, Saudi Arabia. FAU - Eldali, Ahmed AU - Eldali A AD - Plastic Surgery Division, Department of Surgery, Ministry of National Guard - Health Affairs, Riyadh, Saudi Arabia. FAU - Alqahtani, Rahaf AU - Alqahtani R AD - 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. AD - King Abdullah International Medical Research Center-King Saud Bin Abdulaziz University for Health Sciences, Ministry of National Guard - Health Affairs, Riyadh, Saudi Arabia. FAU - Vishwakarma, Ramesh AU - Vishwakarma R AD - Norwich Medical School, University of East Anglia, Norwich, UK. FAU - Al-Dorzi, Hasan M AU - Al-Dorzi HM AD - Intensive Care Department, King Abdulaziz Medical City, Riyadh, Saudi Arabia. AD - College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia. LA - eng SI - ClinicalTrials.gov/NCT05237726 PT - Comparative Study PT - Journal Article PT - Randomized Controlled Trial DEP - 20240119 PL - Germany TA - Eur J Trauma Emerg Surg JT - European journal of trauma and emergency surgery : official publication of the European Trauma Society JID - 101313350 RN - 0 (Enoxaparin) RN - 0 (Anticoagulants) RN - 9005-49-6 (Heparin) SB - IM MH - Humans MH - Male MH - Female MH - *Burns/complications MH - *Enoxaparin/administration & dosage MH - *Venous Thromboembolism/prevention & control MH - *Anticoagulants/administration & dosage/adverse effects/therapeutic use MH - Middle Aged MH - *Heparin/administration & dosage MH - Adult MH - Pilot Projects MH - Hemorrhage/chemically induced MH - Critical Illness OTO - NOTNLM OT - Bleeding OT - Burn OT - Enoxaparin OT - Intensive care OT - Mortality OT - Thermal injury OT - Thrombosis OT - Unfractionated heparin OT - VTE pharmaco-prophylaxis EDAT- 2024/01/19 12:44 MHDA- 2024/04/23 15:49 CRDT- 2024/01/19 11:04 PHST- 2023/06/20 00:00 [received] PHST- 2023/12/31 00:00 [accepted] PHST- 2024/04/23 15:49 [medline] PHST- 2024/01/19 12:44 [pubmed] PHST- 2024/01/19 11:04 [entrez] AID - 10.1007/s00068-024-02443-9 [pii] AID - 10.1007/s00068-024-02443-9 [doi] PST - ppublish SO - Eur J Trauma Emerg Surg. 2024 Apr;50(2):567-579. doi: 10.1007/s00068-024-02443-9. Epub 2024 Jan 19.