Trial · NCT05081063
Low-Titer O Positive Whole Blood Versus Component Therapy for Emergent Transfusion in Trauma Patients
NCT05081063, Phase 3, Completed, Loma Linda University; results first posted 2025-08-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Low-Titer O Positive Whole Blood Versus Component Therapy for Emergent Transfusion in Trauma Patients. Trials, record NCT05081063. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05081063
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Low-Titer O Positive Whole Blood Versus Component Therapy for Emergent Transfusion in Trauma Patients
- NCT number
- NCT05081063
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 199 participants, actual
- Lead sponsor
- Loma Linda University
- Conditions
- Hemorrhagic Shock, Acute Blood Loss Anemia, Traumatic Brain Injury
- Interventions
- Routine labs
- First posted
- 2021-10-18
- Last updated
- 2025-08-08
- Results first posted
- 2025-08-08
- Limitations and caveats
- Sample size Difference between size of groups Pragmatic randomization scheme
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Packed Red Blood Cells Equivalents Units Transfused (1 Whole Blood Unit Treated as 1 Packed Red Blood Cell Unit and 1 Fresh Frozen Plasma Unit) | The total transfusion requirement of packed red blood cells was analyzed for the duration of the inpatient hospitalization for patients surviving at least 24 hours. This time is defined as a time period up to 30 days. | assessment of pRBC equivalents transfused in each arm, an increase in HGB by 1g/dl per unit transfused will be considered successful A blood draw of 5ml will be obtained and tested to assess HGB level. An increase in HGB by 1g/dl per unit transfused will be considered a successful result. |
| Secondary | Mortality | In patients surviving at least 24 hours who were included in analysis of outcome measures, we assessed survival to hospital discharge. This means the duration of time in the hospital up to discharge with a maximum of 30 days. | Assessment of mortality This is a composite measurement which includes the following in order to be assessed as pulseless with no respiratory drive or brain death: 1. there is no evidence of arousal or awareness to maximal external stimuli 2. pupils are fixed in a midsized or dilated position and non reactive to light 3. corneal, oculocephalic and oculovestibular reflexes are absent 4. There is no facial movement to noxious stimuli 5. the gag reflex is absent to bilateral posterior pharyngeal stimuli 6. the cough reflex is absent to deep tracheal suctioning 7. there is no brain mediated motor response to noxious stimuli of the limbs 8. spontaneous respirations are not observed when apnea test targets reach pH \<7.30 and PaCO2 \>60mmhg |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Packed Red Blood Cells Equivalents Units Transfused (1 Whole Blood Unit Treated as 1 Packed Red Blood Cell Unit and 1 Fresh Frozen Plasma Unit) | The total transfusion requirement of packed red blood cells was analyzed for the duration of the inpatient hospitalization for patients surviving at least 24 hours. This time is defined as a time period up to 30 days. | Population of patients surviving 24 hours analyzed for transfusion measures | units | MEAN |
| SECONDARY | Mortality | In patients surviving at least 24 hours who were included in analysis of outcome measures, we assessed survival to hospital discharge. This means the duration of time in the hospital up to discharge with a maximum of 30 days. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Packed Red Blood Cells Equivalents Units Transfused (1 Whole Blood Unit Treated as 1 Packed Red Blood Cell Unit and 1 Fresh Frozen Plasma Unit) | Low Titer O+ Whole Blood | 3.8 | Standard Deviation 5.6 | units | |
| Packed Red Blood Cells Equivalents Units Transfused (1 Whole Blood Unit Treated as 1 Packed Red Blood Cell Unit and 1 Fresh Frozen Plasma Unit) | Component Therapy | 5.7 | Standard Deviation 6.2 | units | |
| Mortality | Low Titer O+ Whole Blood | 4 | Participants | ||
| Mortality | Component Therapy | 13 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Low Titer O+ Whole Blood | 52 | |
| Overall Study | STARTED | Component Therapy | 147 | |
| Overall Study | COMPLETED | Low Titer O+ Whole Blood | 52 | |
| Overall Study | COMPLETED | Component Therapy | 147 | |
| Overall Study | NOT COMPLETED | Low Titer O+ Whole Blood | 0 | |
| Overall Study | NOT COMPLETED | Component Therapy | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Low Titer O+ Whole Blood | 17 | 52 |
| Total, all-cause mortality | Component Therapy | 37 | 147 |
| Total, other adverse events | Low Titer O+ Whole Blood | 0 | 52 |
| Total, other adverse events | Component Therapy | 0 | 147 |
| Total, serious adverse events | Low Titer O+ Whole Blood | 0 | 52 |
| Total, serious adverse events | Component Therapy | 0 | 147 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Low Titer O+ Whole Blood vs Component Therapy: Mortality | Trial comparisons |
| Low Titer O+ Whole Blood vs Component Therapy: deaths from any cause | Trial comparisons |
| Low Titer O+ Whole Blood vs Component Therapy: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05081063
GET https://conductscience.org/api/trials/v1/NCT05081063/registered