Optimization Strategies for Blood Transfusion Protocols in the Emergency Treatment of Hemorrhagic Shock
1 other identifier
interventional
180
1 country
1
Brief Summary
This single-center, prospective, randomized controlled trial was approved by the institutional ethics committee and overseen by an independent data and safety monitoring board. It enrolled patients with hemorrhagic shock caused by trauma or major gastrointestinal bleeding. Using a random-number-table method, participants were allocated to three groups: (1) Control group: standard massive transfusion protocol (MTP) with transfusing type-specific blood components in a 1:1:1 ratio. (2) Type-specific whole-blood group: following emergency ABO typing and cross-matching, type-specific whole blood was transfused. (3) Low-titer group O whole-blood group: in the emergency phase, 4 units of low-titer group O whole blood (anti-A/B IgM titer \< 1:64) were infused; after definitive ABO typing, patients were switched to type-specific whole blood. Clinical data were automatically extracted from the electronic medical record system. Primary endpoints were efficacy (28-day survival), timeliness (transfusion waiting time and time to achieve target mean arterial pressure), cost-effectiveness (total blood consumption and transfusion-related expenses), and safety (transfusion-associated adverse events including TRALI and hemolytic reactions).Statistical analyses included Kaplan-Meier survival curves and Cox proportional-hazards regression, adjusting for confounders such as age and disease severity scores. The advantages and disadvantages of each transfusion strategy were evaluated, and an optimized strategy for emergency blood transfusion in hemorrhagic shock was developed. This strategy was peer-reviewed and refined, culminating in a standardized, multidisciplinary, emergency-transfusion protocol.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2025
CompletedFirst Posted
Study publicly available on registry
August 19, 2025
CompletedStudy Start
First participant enrolled
September 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
August 19, 2025
August 1, 2025
1.8 years
August 9, 2025
August 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
survival rate
24 hours,30 days
Study Arms (3)
group of 1:1:1 component transfusion
ACTIVE COMPARATORFollowing the "Chinese Expert Consensus on Emergency Blood Support Models and Transfusion Strategies for Severely Injured Patients (2024 Edition)", implement the massive transfusion protocol (MTP) by transfusing type-specific blood components in a 1:1:1 ratio (red blood cells : plasma : platelets).
group of ABO- and Rh-compatible whole blood
ACTIVE COMPARATORAdminister type-specific whole-blood transfusion in accordance with the "Chinese Expert Consensus on Emergency Blood Support Models and Transfusion Strategies for Severely Injured Patients (2024 Edition)".
low-titer O-group whole blood
EXPERIMENTALDuring the emergency phase, administer 4 units of low-titer group O whole blood (anti-A/B IgM antibody titer \< 1:64); once the patient's blood type is determined, switch to type-specific whole blood.
Interventions
Arm Description: During the emergency phase, administer 4 units of low-titer group O whole blood (anti-A/B IgM antibody titer \< 1:64); once the patient's blood type is determined, switch to type-specific whole blood.
Following the "Chinese Expert Consensus on Emergency Blood Support Models and Transfusion Strategies for Severely Injured Patients (2024 Edition)", implement the massive transfusion protocol (MTP) by transfusing type-specific blood components in a 1:1:1 ratio (red blood cells : plasma : platelets).
Administer type-specific whole-blood transfusion in accordance with the "Chinese Expert Consensus on Emergency Blood Support Models and Transfusion Strategies for Severely Injured Patients (2024 Edition)".
Eligibility Criteria
You may qualify if:
- Patients with hemorrhagic shock due to trauma or upper gastrointestinal bleeding who meet emergency transfusion criteria (hemoglobin \< 7 g/dL or active bleeding).
- Age 10-90 years. Time from onset to hospital admission \< 24 hours.
You may not qualify if:
- Severe underlying diseases (end-stage organ failure or active malignancy). Known coagulopathy or history of severe transfusion reactions. Refusal to participate or inability to complete follow-up.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xijing Hospitallead
Study Sites (1)
Xijing Hospital
Xi'an, Shannxi, 710032, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
lijunjie li
Xijing Hospital
- PRINCIPAL INVESTIGATOR
liushanshou liu
Xijing Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- chief physician
Study Record Dates
First Submitted
August 9, 2025
First Posted
August 19, 2025
Study Start
September 1, 2025
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
August 19, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- January 2026-January 2028
- Access Criteria
- 1\. The IPD and supporting information will be accessible to the following parties: * Principal Investigator (PI) and Study Team: The PI and designated members of the study team, including co-investigators, biostatisticians, and data managers, will have access to the IPD and supporting information for the purpose of conducting the study, analyzing data, and preparing reports. * Independent Data and Safety Monitoring Board (DSMB): The DSMB will have access to the IPD and supporting information to monitor the safety and efficacy of the study interventions and to provide recommendations based on interim analyses. * Ethics Committees: These committees may request access to the IPD and supporting information to ensure compliance with ethical standards and to review the study protocol and conduct. * Sponsor and Sponsor's Representatives: The sponsor of the study and their designated representatives may have access to the IPD and supporting information for oversight and monitoring of the study
The following de-identified individual participant data (IPD) will be shared via a public repository (Dryad Digital Repository) no later than 12 months after the primary results publication. Participant-level baseline characteristics • Age, sex, body-mass index, Injury Severity Score (ISS), baseline hemoglobin, vital signs on arrival, coagulation parameters (INR, platelet count, fibrinogen), lactate. Intervention allocation and delivery data • Randomization group, actual blood products transfused (type, volume, sequence, total units), time from randomization to first transfusion. Primary and secondary outcomes (28-day follow-up) * Vital status at 28 days (alive/dead), date and cause of death if applicable. * Time to achieve mean arterial pressure ≥ 65 mmHg, total blood products and crystalloids within 24 h, incidence and date of TRALI, TACO, acute hemolytic reactions, ICU length of stay, hospital length of stay, total transfusion-related costs. Safety events • All-grade and grade ≥3 ad