HemorrhagePhase 3NCT07129031
Optimization Strategies for Blood Transfusion Protocols in the Emergency Treatment of Hemorrhagic Shock
A Phase 3 study testing low-titer O-group whole blood, 1:1:1 component transfusion and ABO- and Rh-compatible whole blood in people with Hemorrhage and Hemorrhagic Shock, run by Xijing Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 90 years
- Conditions the study is for
- Hemorrhage, Hemorrhagic Shock, Upper Gastrointestinal Bleeding (UGIB)
- What is being tested?
- low-titer O-group whole blood, 1:1:1 component transfusion and ABO- and Rh-compatible whole blood
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 31 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Xijing Hospital
Xi'an, Shannxi, 710032
zheng Daizheng, 13088973590, 1450494627@qq.com
About this study
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.
- Being tested
- low-titer O-group whole blood, 1:1:1 component transfusion, ABO- and Rh-compatible whole blood
- Keywords
- Hemorrhagic shock, transfusion, low-titer O-group whole blood, group of 1:1:1 component, group of ABO- and Rh-compatible whole blood
- Medical subject headings
- Hemorrhage, Shock, Hemorrhagic, Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-titer O-group whole bloodDrug
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.
1:1:1 component transfusionDrug
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).
ABO- and Rh-compatible whole bloodDrug
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)".
| Study group | Role | What they receive |
|---|---|---|
| group of 1:1:1 component transfusion | Active comparator | 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). Receives: Drug: 1:1:1 component transfusion |
| group of ABO- and Rh-compatible whole blood | Active comparator | 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)". Receives: Drug: ABO- and Rh-compatible whole blood |
| low-titer O-group whole blood | Experimental | 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. Receives: Drug: low-titer O-group whole blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival rate
Measured: 24 hours,30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhageStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yin wen, Xijing Hospital
- Investigators
- lijunjie li, Study director, Xijing Hospitalliushanshou liu, Principal investigator, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07129031
- Sponsor's protocol ID
- KY20252202
- Status last verified
- Aug 2025
- First submitted
- 9 Aug 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization Strategies for Blood Transfusion Protocols in the Emergency Treatment of Hemorrhagic Shock
- ClinicalTrials.gov ID
- NCT07129031
- Acronym / sponsor ID
- KY20252202
- Keywords
- Hemorrhagic shock, transfusion, low-titer O-group whole blood, group of 1:1:1 component, group of ABO- and Rh-compatible whole blood
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group of 1:1:1 component transfusion | Active comparator | Drug: 1:1:1 component transfusionFollowing 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 comparator | Drug: ABO- and Rh-compatible whole bloodAdminister 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 | Experimental | Drug: low-titer O-group whole bloodDuring 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. |
Who may qualify
- Ages
- 10 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low-titer O-group whole bloodArm 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. | Drug | low-titer O-group whole blood |
| 1:1:1 component transfusionFollowing 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). | Drug | group of 1:1:1 component transfusion |
| ABO- and Rh-compatible whole bloodAdminister 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)". | Drug | group of ABO- and Rh-compatible whole blood |
Primary outcome
survival rate
Time frame: 24 hours,30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
lijunjie li study director
Xijing Hospital
liushanshou liu principal investigator
Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing low-titer O-group whole blood, 1:1:1 component transfusion and ABO- and Rh-compatible whole blood in people with Hemorrhage and Hemorrhagic Shock, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival rate (time frame: 24 hours,30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.