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Major TraumaALTRNCT05996068

Arterial Line in Trauma Resuscitation

A study testing arterial line in people with Major Trauma, run by National Taiwan University Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Major Trauma
What is being tested?
arterial line
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
216 participants
Where
1 siteTaiwan
Study dates
1 Jan 2023to 30 Jun 2025
Phase
Interventional
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 14Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • National Taiwan University Hospital Yunlin Branch

    Douliu

Other trials in Taiwan

About this study

Official 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.

Conditions
Major Trauma
Being tested
arterial line
Keywords
major trauma, arterial line, resuscitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • arterial lineDevice

    insert arterial line for patients who meet major trauma criteria

Study groups in NCT05996068
Study groupRoleWhat they receive
trauma patients with arterial line insertionActive comparatorthe after phase, actively recruited patients who are eligible for arterial line insertion
Receives: Device: arterial line
trauma patients without arterial line insertionNo interventionthe before phase, retrospectively data collection from the past

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: during ER stay, up to 6 hours

Secondary outcomes (6)

  1. prolong ICU admission

    define as > 6 days of admission

    Measured: up to 7 days

  2. 30 days mortality rate

    mortality within 30 days of trauma event

    Measured: mortality within 30 days of trauma event

  3. volume of fluid administration

    any type of fluid administration

    Measured: during ER stay, up to 6 hours

  4. Area under curve (AUC) difference under different time measuring frequency

    We will use continuous blood pressure data and apply different intervals (1, 3, 5, and 10 minutes) to create a plot, then smooth it to calculate the area under the curve (AUC).

    Measured: 1/3/5/10 minutes

  5. units of red blood cell transfusion

    units of red blood cell transfusion

    Measured: during ER stay, up to 6 hours

  6. arterial blood pressure trajectory

    We will depict the arterial blood pressure trajectory for each patient.

    Measured: during ER stay, up to 6 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2023
  2. Study start1 Jan 2023
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion30 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Single group
Model description
We use se before-after study type and only the after phase receive intervention. Before phase will retrospectively collect data from patient without arterial line intervention.
Masking
None (open label)
Enrolment
216 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05996068
Sponsor's protocol ID
202210095DINC
Acronym
ALTR
Status last verified
Aug 2024
First submitted
3 Aug 2023
Last updated
13 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 18212658

  • 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.

    PubMed 2927596

  • 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.

    PubMed 2213158

  • 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.

    PubMed 17426904

  • 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.

    PubMed 25807399

  • 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.

    PubMed 35887844

Questions about this trial

What is this clinical trial studying?

A study testing arterial line in people with Major Trauma, run by National Taiwan University Hospital at 1 site in Taiwan.

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 14 inclusion and 5 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 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

composite primary endpoint (including any hypotension, vasopressors usage, any cardiac arrest in ER, Shock index ) (time frame: during ER stay, up to 6 hours). 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 NCT05996068, 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 2024.

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