Major Trauma Clinical Trial
— ALTROfficial title:
Enhancing Trauma Resuscitation Through Arterial Line Integration: A Before-After Study
Accident-related deaths is the 7th leading cause of death in Taiwan, and most of them is due to trauma from falls and traffic accident. Among trauma patients, the common cause of death is from hemorrhagic shock. Thus, real-time and accurate blood pressure monitoring is important for trauma patients. Incorrect blood pressure monitoring can lead to adverse events like traumatic cardiac arrest and shock and can also delay the time for intervention (fluid resuscitation, blood transfusion and operation). The current practice of blood pressure monitoring in trauma patient is by non-invasive blood pressure monitoring, which may be incorrect and not timely. Patient's body type and peripheral perfusion can both influence the result of non-invasive blood pressure monitoring. With continuous and correct blood pressure monitoring, the resuscitation team can give adequate and timely treatment. In some trauma centers, arterial line insertion in trauma patients is a daily practice, while the evidence is inadequate and the potential benefit in unknown. The main purpose of this study is to investigate the application of arterial line insertion in trauma patients. The study design is a prospective before-after study to exam whether arterial line insertion in trauma patients can reduce adverse event rate like hypovolemic shock and improve patient's outcomes.
Status | Recruiting |
Enrollment | 216 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Glasgow Coma Scale (GCS) 13 or less - SBP < 90 mmHg - Respiratory rate < 10 or > 29 breaths/min - Fall from height > 6 meters - High-Risk Auto Crash: Partial or complete ejection, intrusion > 30 cm any site, Need for extrication for entrapped patient, Death in passenger compartment - Rider separated from transport vehicle with significant impact - Penetrating injuries to head, neck, torso, and proximal extremities - Skull deformity, suspected skull fracture - Chest wall instability, deformity, or suspected flail chest - Suspected pelvic fracture - Suspected fracture of two or more proximal long bones - Amputation proximal to wrist or ankle - Active bleeding requiring a tourniquet or wound packing with continuous pressure - Burns in conjunction with trauma Exclusion Criteria: - Pregnancy - Patient or family who are unable to obtain informed consent - Known coagulopathy that is inappropriate for arterial line insertion - Known peripheral arterial occlusion disease that is inappropriate for arterial line insertion - traumatic cardiac arrest |
Country | Name | City | State |
---|---|---|---|
Taiwan | National Taiwan University Hospital Yunlin Branch | Douliu |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital |
Taiwan,
Eisenberg HM, Gary HE Jr, Aldrich EF, Saydjari C, Turner B, Foulkes MA, Jane JA, Marmarou A, Marshall LF, Young HF. Initial CT findings in 753 patients with severe head injury. A report from the NIH Traumatic Coma Data Bank. J Neurosurg. 1990 Nov;73(5):688-98. doi: 10.3171/jns.1990.73.5.0688. — View Citation
Klauber MR, Marshall LF, Luerssen TG, Frankowski R, Tabaddor K, Eisenberg HM. Determinants of head injury mortality: importance of the low risk patient. Neurosurgery. 1989 Jan;24(1):31-6. doi: 10.1227/00006123-198901000-00005. — View Citation
Schreiber MA, Meier EN, Tisherman SA, Kerby JD, Newgard CD, Brasel K, Egan D, Witham W, Williams C, Daya M, Beeson J, McCully BH, Wheeler S, Kannas D, May S, McKnight B, Hoyt DB; ROC Investigators. A controlled resuscitation strategy is feasible and safe in hypotensive trauma patients: results of a prospective randomized pilot trial. J Trauma Acute Care Surg. 2015 Apr;78(4):687-95; discussion 695-7. doi: 10.1097/TA.0000000000000600. — View Citation
Teixeira PG, Inaba K, Hadjizacharia P, Brown C, Salim A, Rhee P, Browder T, Noguchi TT, Demetriades D. Preventable or potentially preventable mortality at a mature trauma center. J Trauma. 2007 Dec;63(6):1338-46; discussion 1346-7. doi: 10.1097/TA.0b013e31815078ae. — View Citation
Tieu BH, Holcomb JB, Schreiber MA. Coagulopathy: its pathophysiology and treatment in the injured patient. World J Surg. 2007 May;31(5):1055-64. doi: 10.1007/s00268-006-0653-9. — View Citation
Wijnberge M, van der Ster B, Vlaar APJ, Hollmann MW, Geerts BF, Veelo DP. The Effect of Intermittent versus Continuous Non-Invasive Blood Pressure Monitoring on the Detection of Intraoperative Hypotension, a Sub-Study. J Clin Med. 2022 Jul 14;11(14):4083. doi: 10.3390/jcm11144083. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | composite primary endpoint (including any hypotension, vasopressors usage, any cardiac arrest in ER, Shock index ) | including any hypotension, vasopressors usage, any cardiac arrest in ER, Shock index (HR/SBP)>1 | during ER stay, up to 6 hours | |
Secondary | prolong ICU admission | define as > 6 days of admission | up to 7 days | |
Secondary | 30 days mortality rate | mortality within 30 days of trauma event | mortality within 30 days of trauma event | |
Secondary | volume of fluid administration | any type of fluid administration | during ER stay, up to 6 hours | |
Secondary | units of red blood cell transfusion | units of red blood cell transfusion | during ER stay, up to 6 hours |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT02509390 -
Hyperfibrinogenemia After Major Trauma
|
N/A | |
Recruiting |
NCT04970433 -
The Effects of Acupuncture for Major Trauma
|
N/A | |
Recruiting |
NCT04588311 -
ErythroPOietin Alfa to Prevent Mortality and Reduce Severe Disability in Critically Ill TRAUMA Patients
|
Phase 3 | |
Active, not recruiting |
NCT04144803 -
Brain Oxygenation During Prehospital Anesthesia: an Observational Study
|
||
Completed |
NCT03259776 -
Experiences of Visitors to a Regional Major Trauma Intensive Care Unit
|
||
Recruiting |
NCT05449522 -
Vitamin D for Critically Traumatic Patients
|
N/A | |
Not yet recruiting |
NCT06103292 -
Calcium Levels in Major Trauma
|
||
Recruiting |
NCT02877342 -
Pre-hospital Notification of Injured Patients Presenting to Trauma Centres in India
|
N/A | |
Terminated |
NCT01545635 -
RETIC Trial: Reversal of Trauma Induced Coagulopathy Using Coagulation Factor Concentrates or Fresh Frozen Plasma
|
Phase 3 | |
Completed |
NCT03986736 -
Markers of Tissue Injury and Rhabdomyolysis in Patients With Major Trauma
|
||
Completed |
NCT03005509 -
Structured Trauma Quality Improvement Meetings at Four Trauma Centres in India
|
N/A | |
Completed |
NCT02165137 -
Management of Major Trauma Patients at Aarau Trauma Center - Evaluation of Processes and Patient Outcome
|
||
Active, not recruiting |
NCT06376318 -
Shock and Acute Conditions OutcOmes Platform
|
||
Completed |
NCT06007807 -
Severe Trauma Registry in Tarragona
|
||
Completed |
NCT03354559 -
Trauma Associated Bleeding: Effectiveness of an Early Coagulation Support Protocol
|
N/A | |
Recruiting |
NCT05652790 -
Enhanced Rehabilitation After Major Trauma (PROPERLY)
|
N/A | |
Completed |
NCT00588796 -
Study of Fibrinogen Metabolism During Severe Trauma and Burns
|
N/A | |
Completed |
NCT04216459 -
Effect of Anti-inflammatory and Anti-microbial Co-supplementations in Traumatic ICU Patients at High Risk of Sepsis
|
N/A | |
Terminated |
NCT04551157 -
Impact of Psychoeducational Video on Adjustment to Open Fracture.
|
N/A | |
Completed |
NCT02000674 -
Succinylcholine vs Rocuronium for Prehospital Emergency Intubation
|
Phase 3 |