Massive Blood Transfusion in Trauma PatientsNCT06128057
Comparing TASH Score and Modified TBSS in Trauma Patients in Need for Massive Blood Transfusion
An observational study of Massive Blood Transfusion in Trauma Patients, run by Assiut University.
Trial summary
Evaluate And Compare predictive value of TASH Score And MTBBS In need for Massive Blood Transfusion Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Massive Blood Transfusion in Trauma Patients
- What is being tested?
- Blood products
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 5 Dec 2023to 10 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Adult, Older adult
Study population: Severe trauma patients
Who may be able to join
- patients aged more than 18 years on both gender
- ISS ≥ 16
Who cannot join
- patients below 18 years
- patients with known bleeding disorders such as hemophilia or von Willebrand disease
- non trauma related bleeding : patients with severe hemorrhage unrelated to traumatic injury such as GI bleeding and ruptured aneurysm
- transfer from other facilities if their initial trauma records and scoring data are not available
Trial locations and contacts
No sites are listed yet.
Esam eldeen Abdallah, professor contact
About this study
Official title: Comparing Trauma Associated Severe Hemorrhage "TASH" Score and Modified Traumatic Bleeding Severity Score "MTBSS" in Trauma Patients in Need for Massive Blood Transfusion in Assiut University Hospital
Evaluate And Compare predictive value of TASH Score And MTBBS In need for Massive Blood Transfusion
Read the detailed description
Trauma is defined as a physical injury from an external source of sudden onset and severity, which require immediate medical attention.Despite improvements in trauma systems worldwide, trauma continues to be one of the leading causes of death and disability in all age groups, especially the young and middle age group.
Approximately 5.8 million people die each year due to trauma related injuries, representing 8% of the worldwide mortality Polytrauma is a short verbal equivalent commonly used for severely injured patients usually with associated injury (i.e. two or more severe injuries in at least two different areas of the body), less often with a multiple injury (i.e. two or more severe injuries in one body area). Polytrauma patients usually have a much higher risk of mortalities and disabilities than the risk of expected mortalities in individual injuries patients.
Even though polytrauma can occur due to different causes such as road traffic accidents, fall from heights bullet injuries, suicide and homicide
.Yet the leading cause of traumatic related causes of death worldwide is road traffic accidents Egypt, in particular, has experienced an alarming increase in the burden of traumatic injuries. According to the World Health Organization In 2015 Egypt has one of the highest rates of road accidents worldwide, with more than 12,000 fatalities each year, one of the highest among Eastern Mediterranean countries. Although 90% of world's road trauma related fatalities occur in low- and middle-income countries, Injury
prevention and trauma care programs in these countries have remained deficient. The prediction of ongoing hemorrhage in severe trauma patients is challenging, and 14 scoring systems or algorithms have been developed to guide clinicians in this critical situation , the early identification of trauma patients with ongoing hemorrhage is pivotal for addressing their critical condition. Many of the scores are used in daily clinical practice and seem to be an interesting tool in the management of massive bleeding. The best scoring system would probably be one that combines superior accuracy in predicting the need for MT with an ease of use that would allow early identification of patients requiring Massive blood trasfusion.
Massive blood transfusion has often been defined as transfusion of ≥ 10 units of whole blood or red blood cells (RBC) within 24 h, as an approximation of the replacement of ≥ 1 total blood volume Or transfusion of ≥ 5 RBC units in 4 h, the replacement of ≥ 50% of total blood volume in 3 h, or ≥ 3 RBC units during any 1-h period in the first 24 h after hospital arrival The goal of this study is to reduce mortality by comparing between TASH and modified TBSS in prediction of need for massive blood transfusion in severe trauma patients .
- Being tested
- Blood products
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood productsOther
Massive blood transfusion
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare predictive value of TASH Score And MTBBS In need for Massive Blood Transfusion
Comparing odd number ( TASH score ) with even number (MTBSS ) in prediction for need for massive blood transfusion
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start5 Dec 2023 (estimated)
- Primary completion5 Jul 2025 (estimated)
- Study completion10 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Massive Blood Transfusion in Trauma PatientsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrhman Abouzeid, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06128057
- Sponsor's protocol ID
- TASH score and MTBSS
- Status last verified
- Nov 2023
- First submitted
- 26 Oct 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ogura T, Lefor AK, Masuda M, Kushimoto S. Modified traumatic bleeding severity score: early determination of the need for massive transfusion. Am J Emerg Med. 2016 Jun;34(6):1097-101. doi: 10.1016/j.ajem.2016.02.072. Epub 2016 Mar 3.
PubMed 27021127Yucel N, Lefering R, Maegele M, Vorweg M, Tjardes T, Ruchholtz S, Neugebauer EA, Wappler F, Bouillon B, Rixen D; Polytrauma Study Group of the German Trauma Society. Trauma Associated Severe Hemorrhage (TASH)-Score: probability of mass transfusion as surrogate for life threatening hemorrhage after multiple trauma. J Trauma. 2006 Jun;60(6):1228-36; discussion 1236-7. doi: 10.1097/01.ta.0000220386.84012.bf.
PubMed 16766965Tonglet ML. Early Prediction of Ongoing Hemorrhage in Severe Trauma: Presentation of the Existing Scoring Systems. Arch Trauma Res. 2016 Jun 20;5(4):e33377. doi: 10.5812/atr.33377. eCollection 2016 Dec.
PubMed 28144603Bikbov B, Perico N, Remuzzi G. Mortality landscape in the global burden of diseases, injuries and risk factors study. Eur J Intern Med. 2014 Jan;25(1):1-5. doi: 10.1016/j.ejim.2013.09.002. Epub 2013 Sep 29.
PubMed 24084027Mitra B, Cameron PA, Gruen RL, Mori A, Fitzgerald M, Street A. The definition of massive transfusion in trauma: a critical variable in examining evidence for resuscitation. Eur J Emerg Med. 2011 Jun;18(3):137-42. doi: 10.1097/MEJ.0b013e328342310e.
PubMed 21164344Savage SA, Zarzaur BL, Croce MA, Fabian TC. Redefining massive transfusion when every second counts. J Trauma Acute Care Surg. 2013 Feb;74(2):396-400; discussion 400-2. doi: 10.1097/TA.0b013e31827a3639.
PubMed 23354230
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Trauma Associated Severe Hemorrhage "TASH" Score and Modified Traumatic Bleeding Severity Score "MTBSS" in Trauma Patients in Need for Massive Blood Transfusion in Assiut University Hospital
- ClinicalTrials.gov ID
- NCT06128057
- Acronym / sponsor ID
- TASH score and MTBSS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 5 Dec 2023 (estimated)
- Primary completion
- 5 Jul 2025 (estimated)
- Study completion
- 10 Nov 2025 (estimated)
- First posted
- 13 Nov 2023 (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.
Evaluate And Compare predictive value of TASH Score And MTBBS In need for Massive Blood Transfusion
Detailed description
Trauma is defined as a physical injury from an external source of sudden onset and severity, which require immediate medical attention.Despite improvements in trauma systems worldwide, trauma continues to be one of the leading causes of death and disability in all age groups, especially the young and middle age group.
Approximately 5.8 million people die each year due to trauma related injuries, representing 8% of the worldwide mortality Polytrauma is a short verbal equivalent commonly used for severely injured patients usually with associated injury (i.e. two or more severe injuries in at least two different areas of the body), less often with a multiple injury (i.e. two or more severe injuries in one body area). Polytrauma patients usually have a much higher risk of mortalities and disabilities than the risk of expected mortalities in individual injuries patients.
Even though polytrauma can occur due to different causes such as road traffic accidents, fall from heights bullet injuries, suicide and homicide
.Yet the leading cause of traumatic related causes of death worldwide is road traffic accidents Egypt, in particular, has experienced an alarming increase in the burden of traumatic injuries. According to the World Health Organization In 2015 Egypt has one of the highest rates of road accidents worldwide, with more than 12,000 fatalities each year, one of the highest among Eastern Mediterranean countries. Although 90% of world's road trauma related fatalities occur in low- and middle-income countries, Injury
prevention and trauma care programs in these countries have remained deficient. The prediction of ongoing hemorrhage in severe trauma patients is challenging, and 14 scoring systems or algorithms have been developed to guide clinicians in this critical situation , the early identification of trauma patients with ongoing hemorrhage is pivotal for addressing their critical condition. Many of the scores are used in daily clinical practice and seem to be an interesting tool in the management of massive bleeding. The best scoring system would probably be one that combines superior accuracy in predicting the need for MT with an ease of use that would allow early identification of patients requiring Massive blood trasfusion.
Massive blood transfusion has often been defined as transfusion of ≥ 10 units of whole blood or red blood cells (RBC) within 24 h, as an approximation of the replacement of ≥ 1 total blood volume Or transfusion of ≥ 5 RBC units in 4 h, the replacement of ≥ 50% of total blood volume in 3 h, or ≥ 3 RBC units during any 1-h period in the first 24 h after hospital arrival The goal of this study is to reduce mortality by comparing between TASH and modified TBSS in prediction of need for massive blood transfusion in severe trauma patients .
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Severe trauma patients
Key inclusion criteria (2 listed)
- patients aged more than 18 years on both gender
- ISS ≥ 16
Key exclusion criteria (4 listed)
- patients below 18 years
- patients with known bleeding disorders such as hemophilia or von Willebrand disease
- non trauma related bleeding : patients with severe hemorrhage unrelated to traumatic injury such as GI bleeding and ruptured aneurysm
- transfer from other facilities if their initial trauma records and scoring data are not available
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 |
|---|---|---|
| Blood productsMassive blood transfusion | Other | – |
Primary outcome
Compare predictive value of TASH Score And MTBBS In need for Massive Blood Transfusion
Time frame: Baseline
Comparing odd number ( TASH score ) with even number (MTBSS ) in prediction for need for massive blood transfusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Background: PubMed 27021127Ogura T, Lefor AK, Masuda M, Kushimoto S. Modified traumatic bleeding severity score: early determination of the need for massive transfusion. Am J Emerg Med. 2016 Jun;34(6):1097-101. doi: 10.1016/j.ajem.2016.02.072. Epub 2016 Mar 3.
- Background: PubMed 16766965Yucel N, Lefering R, Maegele M, Vorweg M, Tjardes T, Ruchholtz S, Neugebauer EA, Wappler F, Bouillon B, Rixen D; Polytrauma Study Group of the German Trauma Society. Trauma Associated Severe Hemorrhage (TASH)-Score: probability of mass transfusion as surrogate for life threatening hemorrhage after multiple trauma. J Trauma. 2006 Jun;60(6):1228-36; discussion 1236-7. doi: 10.1097/01.ta.0000220386.84012.bf.
- Background: PubMed 28144603Tonglet ML. Early Prediction of Ongoing Hemorrhage in Severe Trauma: Presentation of the Existing Scoring Systems. Arch Trauma Res. 2016 Jun 20;5(4):e33377. doi: 10.5812/atr.33377. eCollection 2016 Dec.
- Background: PubMed 24084027Bikbov B, Perico N, Remuzzi G. Mortality landscape in the global burden of diseases, injuries and risk factors study. Eur J Intern Med. 2014 Jan;25(1):1-5. doi: 10.1016/j.ejim.2013.09.002. Epub 2013 Sep 29.
- Background: PubMed 21164344Mitra B, Cameron PA, Gruen RL, Mori A, Fitzgerald M, Street A. The definition of massive transfusion in trauma: a critical variable in examining evidence for resuscitation. Eur J Emerg Med. 2011 Jun;18(3):137-42. doi: 10.1097/MEJ.0b013e328342310e.
- Background: PubMed 23354230Savage SA, Zarzaur BL, Croce MA, Fabian TC. Redefining massive transfusion when every second counts. J Trauma Acute Care Surg. 2013 Feb;74(2):396-400; discussion 400-2. doi: 10.1097/TA.0b013e31827a3639.
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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. This study is not recruiting at the moment.
Esam eldeen Abdallah, professor contact
Questions about this trial
What is this clinical trial studying?
An observational study of Massive Blood Transfusion in Trauma Patients, run by Assiut University.
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 4 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: status not confirmed, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdelrhman Abouzeid (01147982986, abdoabuzaid.aaa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare predictive value of TASH Score And MTBBS In need for Massive Blood Transfusion (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06128057, which also lists 6 linked publications.
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 13 Nov 2023.