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TRAHT is a pilot randomized clinical trial designed to evaluate safety and feasibility of two red blood cells transfusion thresholds in moderate or severe traumatic brain injured patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liberal | Active Comparator | Liberal transfusion strategy. Patients will have red blood cells transfused only if Hb < 9.0 g/dL |
|
| Restrictive | Experimental | Restrictive transfusion strategy. Patients will have red blood cells transfused only if Hb < 7.0 g/dL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liberal transfusion strategy | Behavioral | Patients will have red blood cells transfused only if Hb < 9.0 g/dL |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin difference | Hemoglobin difference between restrictive and liberal groups | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of transfused patients | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks | |
| Number of red blood cell packages transfused | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| André LN Gobatto, M.D. | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo | São Paulo | São Paulo | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41114449 | Derived | Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6. | |
| 38961443 | Derived |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Restrictive transfusion strategy | Behavioral | Patients will have red blood cells transfused only if Hb < 7.0 g/dL |
|
| ICU mortality | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
| Hospital mortality | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
| 180 days mortality | Participants will be followed for 180 after hospital discharge |
| Blood stream infection | Positive blood culture with a pathogenic microorganism | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
| Re-bleeding | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
| Intensity of measures to reduce intracranial pressure | Measures to reduce intracranial pressure such as sedation, hypertonic solutions, hypothermia, liquorice drainage, decompressive craniectomy or hyperventilation | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
| Hospital length of stay | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
| ICU length of stay | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
| Mechanical ventilation free days | Days breathing without assistance from hospital admission to day 28. | 28 days |
| Extended Glasgow Outcome Scale at hospital discharge | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
| Extended Glasgow Outcome Scale after 6 months | 180 days |
| Myocardial Infarction | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
| Acute Respiratory Distress Syndrome | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
| Septic Shock | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
| Cerebral autoregulation | Cerebral autoregulation as measure by the transcranial doppler | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
| Pulsatility index | Pulsatility index as measure by the transcranial doppler | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
| Gobatto ALN, Solla D, Brasil S, Taccone FS, Carlotti CG Jr, Malbouisson LMS, Paiva WS. Progressive hemorrhagic injury and ischemia after severe traumatic brain injury according to hemoglobin transfusion thresholds: a post-hoc analysis of the transfusion requirements after head trauma trial. Crit Care. 2024 Jul 3;28(1):218. doi: 10.1186/s13054-024-04981-5. No abstract available. |
| 34932836 | Derived | Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5. |
| 30871608 | Derived | Gobatto ALN, Link MA, Solla DJ, Bassi E, Tierno PF, Paiva W, Taccone FS, Malbouisson LM. Transfusion requirements after head trauma: a randomized feasibility controlled trial. Crit Care. 2019 Mar 12;23(1):89. doi: 10.1186/s13054-018-2273-9. |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |