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Breath Test–Based Red Blood Cell Lifespan Measurement to Guide Transfusion Decision-Making in Neurocritically Ill Patients with Anemia: A Multicenter, Prospective, Proof-of-Concept Study

Breath Test–Based Red Blood Cell Lifespan Measurement to Guide Transfusion Decision-Making in Neurocritically Ill Patients with Anemia: A Multicenter, Prospective, Proof-of-Concept Study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600125650
Enrollment
Unknown
Registered
2026-05-29
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute brain injury

Interventions

Normal RBC Lifespan Group and Shortened RBC Lifespan Group:None

Sponsors

Xuanwu Hospital Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >18 years, regardless of gender; 2. Acute severe brain injury confirmed by head CT or MRI (within 7 days of onset or injury), including but not limited to: traumatic brain injury (TBI), spontaneous intracerebral hemorrhage (ICH), subarachnoid hemorrhage (SAH), or large hemispheric infarction (LHI); 3. Critical condition requiring admission to the Neurological Intensive Care Unit (NICU) or general ICU, with a clinical prognosis suggesting a life expectancy exceeding 72 hours (to ensure sufficient time for baseline RBCLS testing and intervention observation); 4. Development of anemia (hemoglobin <9.0 g/dL) during ICU stay, indicating potential need for transfusion; 5. Relatively stable hemodynamics and vital signs at enrollment, providing the basic conditions for accepting non-invasive breath testing and implementing strict transfusion threshold management; 6. Written informed consent has been signed by the patient or their legal representative.

Exclusion criteria

Exclusion criteria: 1. Core technical factors interfering with RBCLS (CO breath test) determination (1) Recent history of red blood cell transfusion (absolute contraindication): Receipt of any form of exogenous red blood cell suspension transfusion within 7 days prior to enrollment (as this results in the measured lifespan in exhaled breath being a mixed value of autologous and donor red blood cells). (2) Exogenous CO exposure: A clear history of carbon monoxide poisoning, or a history of heavy smoking (>10 cigarettes/day) within 24 hours prior to enrollment. (3) Abnormal endogenous CO production: Presence of severe non-critical care-related hemolytic diseases unrelated to the current brain injury, severe rhabdomyolysis, or severe sepsis with hyperbilirubinemia (total bilirubin >3 mg/dL and progressively increasing). (4) Impairment in terminal alveolar gas sampling: Presence of severe acute respiratory distress syndrome (ARDS) requiring very high airway pressure support, severe pulmonary bullae, pneumothorax, bronchopleural fistula, etc., resulting in the inability to collect qualified alveolar gas samples under mechanical ventilation or spontaneous breathing. 2. Clinically critical factors preventing the execution of transfusion strategies (1) Active massive hemorrhage: Presence of active bleeding requiring urgent intervention (such as TBI combined with severe rupture of abdominal solid organs, massive hemorrhage from pelvic fractures, or severe gastrointestinal stress ulcer bleeding >100 ml); such patients require urgent initiation of a Massive Transfusion Protocol (MTP) and cannot adhere to preset transfusion thresholds. (2) Moribund state: Being in a clinically irreversible moribund state at enrollment (such as GCS = 3 with no spontaneous breathing, bilateral fixed and dilated pupils, or during brain death evaluation). 3. Primary hematologic diseases affecting red blood cell homeostasis (1) Clearly diagnosed primary hematologic diseases, such as myelodysplastic syndromes (MDS), aplastic anemia, thalassemia, autoimmune hemolytic anemia, etc. 4. Compliance and restrictions for special populations (1) Inability to cooperate due to extreme agitation, with failure to collect qualified exhaled breath samples even under sedation; or persistently significantly elevated CO levels in the initial measurement that exceed normal physiological explanations (considered test failure). (2) Pregnant or lactating women. (3) Other circumstances deemed by the investigator as unsuitable for participation in this trial.

Design outcomes

Primary

MeasureTime frame
Poor neurological functional outcome rate at 6 months after onset/injury;

Secondary

MeasureTime frame
Short-term improvement in clinical status;Incidence of transfusion-related complications and all-cause mortality;Early dynamic changes in RBCLS and Hb;

Countries

China

Contacts

Public ContactJiang Rongcai

Tianjin Medical University General Hospital

jiang116216@163.com+86 22 60362255

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026