Effect of different red blood cell transfusion strategies on the outcome of neurocritical patients: a randomized, controlled, clinical trial protocol.
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| Názov: | Effect of different red blood cell transfusion strategies on the outcome of neurocritical patients: a randomized, controlled, clinical trial protocol. |
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| Autori: | Fu Y; Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, No. 119, Southwest 4th Ring Road, Fengtai District, Beijing, People's Republic of China., Lu R; Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, No. 119, Southwest 4th Ring Road, Fengtai District, Beijing, People's Republic of China., Wang T; Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, No. 119, Southwest 4th Ring Road, Fengtai District, Beijing, People's Republic of China., Cui W; Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, No. 119, Southwest 4th Ring Road, Fengtai District, Beijing, People's Republic of China., Han R; Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, No. 119, Southwest 4th Ring Road, Fengtai District, Beijing, People's Republic of China., Yu Y; Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, No. 119, Southwest 4th Ring Road, Fengtai District, Beijing, People's Republic of China. yy_waitou@163.com. |
| Zdroj: | Trials [Trials] 2025 Nov 26; Vol. 26 (1), pp. 552. Date of Electronic Publication: 2025 Nov 26. |
| Spôsob vydávania: | Journal Article; Clinical Trial Protocol |
| Jazyk: | English |
| Informácie o časopise: | Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: [London] : BioMed Central, 2006- |
| Výrazy zo slovníka MeSH: | Erythrocyte Transfusion*/methods , Erythrocyte Transfusion*/adverse effects , Erythrocyte Transfusion*/mortality , Subarachnoid Hemorrhage*/therapy , Subarachnoid Hemorrhage*/mortality , Cerebral Hemorrhage*/therapy , Cerebral Hemorrhage*/mortality , Brain Injuries, Traumatic*/therapy , Brain Injuries, Traumatic*/mortality, Humans ; Prospective Studies ; Randomized Controlled Trials as Topic ; Treatment Outcome ; Time Factors ; Hospital Mortality ; Adult ; China ; Female ; Glasgow Outcome Scale |
| Abstrakt: | Competing Interests: Declarations. Ethics approval and consent to participate: Before the study started, it was approved by the Ethics Committee of Beijing Tiantan Hospital, Capital Medical University (KY2023-116-03). Consent for publication: Written informed consent for publication will be obtained from all participants. Competing interests: The authors declare no competing interests. Background: Neurocritical diseases such as subarachnoid hemorrhage, traumatic brain injury, and cerebral hemorrhage are the main cause of death and long-term disability. Red blood cell (RBC) transfusion can improve the oxygen supply to the brain, but may lead to complications such as cerebral vasospasm. The optimal threshold is unknown. We conducted a randomized trial to explore the optimal RBC transfusion strategy for neurocritical patients based on perioperative blood protection: liberal RBC transfusion strategy or restrictive RBC transfusion strategy. Methods: This is a single-center, prospective, randomized, controlled trial. A total of 234 neurocritical patients will be randomly assigned to the liberal RBC transfusion strategy (90 g/L) group and the restrictive RBC transfusion strategy (70 g/L) group in a 1:1 ratio. The primary outcome is the neurological outcome at discharge. Further safety and efficacy parameters include the Glasgow Outcome Scale extended score at 6 months after surgery, in-hospital mortality, the incidence of transfusion reactions, and the incidence of systemic complications. Discussion: This is a prospective randomized controlled study to investigate the effect of a liberal RBC transfusion strategy (90 g/L) versus a restrictive RBC transfusion strategy (70 g/L) on the outcome of neurocritical patients. Transfusion strategies for neurocritical patients with impaired autoregulation of cerebral blood flow have been controversial, so it is necessary to explore transfusion strategies that are more suitable for these patients. This study will be carried out on the basis of blood protection, that is, intraoperative autotransfusion will be used during the surgery, which was not involved in previous studies. The results of this study will provide a theoretical basis for the use of blood products in neurocritical patients. Trial Registration: This study conforms to the principles of the Helsinki Declaration. This trial is registered at the Chinese Clinical Trial Registry (ChiCTR2400083713) on April 30, 2024. Before the study started, it was approved by the Ethics Committee of Beijing Tiantan Hospital, Capital Medical University (KY2023-116-03). (© 2025. The Author(s).) |
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| Grant Information: | No. bnmr-2022-006 Bethune Charitable Foundation; No. XSKY2023297 Guangzhou Municipal Research Collaborative Innovation Projects; No. 2022JYY228 Natural Science Research Project of Guizhou Province |
| Contributed Indexing: | Keywords: Neurocritical patients; Perioperative period; Red blood cell; Transfusion strategies |
| Entry Date(s): | Date Created: 20251127 Date Completed: 20251127 Latest Revision: 20251129 |
| Update Code: | 20251129 |
| PubMed Central ID: | PMC12659489 |
| DOI: | 10.1186/s13063-025-09277-9 |
| PMID: | 41299708 |
| Databáza: | MEDLINE |
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Nájsť tento článok vo Web of Science | Abstrakt: | Competing Interests: Declarations. Ethics approval and consent to participate: Before the study started, it was approved by the Ethics Committee of Beijing Tiantan Hospital, Capital Medical University (KY2023-116-03). Consent for publication: Written informed consent for publication will be obtained from all participants. Competing interests: The authors declare no competing interests.<br />Background: Neurocritical diseases such as subarachnoid hemorrhage, traumatic brain injury, and cerebral hemorrhage are the main cause of death and long-term disability. Red blood cell (RBC) transfusion can improve the oxygen supply to the brain, but may lead to complications such as cerebral vasospasm. The optimal threshold is unknown. We conducted a randomized trial to explore the optimal RBC transfusion strategy for neurocritical patients based on perioperative blood protection: liberal RBC transfusion strategy or restrictive RBC transfusion strategy.<br />Methods: This is a single-center, prospective, randomized, controlled trial. A total of 234 neurocritical patients will be randomly assigned to the liberal RBC transfusion strategy (90 g/L) group and the restrictive RBC transfusion strategy (70 g/L) group in a 1:1 ratio. The primary outcome is the neurological outcome at discharge. Further safety and efficacy parameters include the Glasgow Outcome Scale extended score at 6 months after surgery, in-hospital mortality, the incidence of transfusion reactions, and the incidence of systemic complications.<br />Discussion: This is a prospective randomized controlled study to investigate the effect of a liberal RBC transfusion strategy (90 g/L) versus a restrictive RBC transfusion strategy (70 g/L) on the outcome of neurocritical patients. Transfusion strategies for neurocritical patients with impaired autoregulation of cerebral blood flow have been controversial, so it is necessary to explore transfusion strategies that are more suitable for these patients. This study will be carried out on the basis of blood protection, that is, intraoperative autotransfusion will be used during the surgery, which was not involved in previous studies. The results of this study will provide a theoretical basis for the use of blood products in neurocritical patients.<br />Trial Registration: This study conforms to the principles of the Helsinki Declaration. This trial is registered at the Chinese Clinical Trial Registry (ChiCTR2400083713) on April 30, 2024. Before the study started, it was approved by the Ethics Committee of Beijing Tiantan Hospital, Capital Medical University (KY2023-116-03).<br /> (© 2025. The Author(s).) |
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| ISSN: | 1745-6215 |
| DOI: | 10.1186/s13063-025-09277-9 |