- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06128057
Comparing TASH Score and Modified TBSS in Trauma Patients in Need for Massive Blood Transfusion
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Abdelrhman Abouzeid
- Phone Number: 01147982986
- Email: abdoabuzaid.aaa@gmail.com
Study Contact Backup
- Name: Esam eldeen Abdallah, professor
- Email: esamel_deen@yahoo.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients aged more than 18 years on both gender
- ISS ≥ 16
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Bikbov 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.
- 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.
- Yucel 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.
- Tonglet 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.
- Mitra 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.
- Savage 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TASH score and MTBSS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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