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AzTrials

SurgerySPATHNCT07223853

AI-driven Clinical Decision Support for Perioperative Blood Orders

A study testing S-PATH clinical decision support system in people with Surgery, run by Washington University School of Medicine at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

20 million patients have surgery in the United States every year, with approximately 1 million of those patients requiring life-saving blood transfusion. Presurgical preparation for transfusion is important to allow for safe and timely transfusion during surgery; however, excessive preparation is unfortunately common… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Surgery
What is being tested?
S-PATH clinical decision support system
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
28 Oct 2025to 1 Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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

Clinician Level Exclusion Criteria:

  • Clinician (resident physician or advanced practice provider) who works at a preoperative assessment clinic

Clinician Level Exclusion Criteria:

  • None

Patient Inclusion Criteria:

  • Scheduled for surgery in one of the main operating room areas (non-remote) at Barnes Jewish Hospital
  • Evaluated in-person at one of the preoperative assessment clinics affiliated with BJC Healthcare
  • Have a valid S-PATH model prediction prior to their preoperative assessment clinic visit

Patient Exclusion Criteria:

  • Pregnant
  • Presence or history of red cell alloantibodies

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sunny S Lou, MD, PhD contact

314-362-5000

slou@wustl.edu

United States1 site, 1 recruiting

  • Washington University / Barnes Jewish Hospital

    St Louis, Missouri, 63110

    Sunny S Lou, MD, PhD, 314-362-5000, slou@wustl.edu

    Recruiting

Other trials in United States

About this study

Official title: Intelligent Clinical Decision Support for Preoperative Blood Management: A Cluster-Randomized Clinical Trial

20 million patients have surgery in the United States every year, with approximately 1 million of those patients requiring life-saving blood transfusion. Presurgical preparation for transfusion is important to allow for safe and timely transfusion during surgery; however, excessive preparation is unfortunately common, costly, and contributes to blood waste. This study aims to evaluate an intelligent clinical decision support system that helps clinicians prepare blood for patients who are likely to need it, while avoiding excessive preparation for patients who don't, potentially improving patient safety while reducing blood waste and healthcare costs.

Conditions
Surgery
Being tested
S-PATH clinical decision support system, Usual care
Keywords
artificial intelligence, clinical decision support, machine learning, surgery, perioperative blood management, anesthesia, pretransfusion testing

What participants receive

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

  • S-PATH clinical decision support systemOther

    Access to the S-PATH electronic health record (EHR)-integrated clinical decision support system

  • Usual careOther

    Including use of the conventional Maximum Surgical Blood Ordering Schedule (MSBOS)

Study groups in NCT07223853
Study groupRoleWhat they receive
Usual careActive comparatorUsual care for determining presurgical blood orders, including use of the institutional Maximum Surgical Blood Ordering Schedule (MSBOS)
Receives: Other: Usual care
S-PATHExperimentalAccess to the S-PATH clinical decision support system
Receives: Other: S-PATH clinical decision support system

What is being measured

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

  1. Frequency of patients with a type and screen order placed during the preoperative clinic assessment visit

    This is a binary outcome at the patient / surgical case level, which will be aggregated across all patients in the study to produce an overall frequency. Placement of a type and screen order during the preoperative clinic assessment visit will be evaluated at the patient / surgical case level. This includes orders placed and collected during the preoperative clinic assessment visit, as well as orders signed during the preoperative clinic assessment visit or subsequent follow up care and held to be drawn on the day of surgery.

    Measured: Decision made during the preoperative assessment clinic visit

Secondary outcomes (6)

  1. Frequency of a valid type and screen order at the start of surgery

    This is a binary outcome at the patient / surgical case level, which will be aggregated across all patients in the study to produce an overall frequency. Valid type and screen order at the start of surgery (defined as resulted prior to 1h after anesthesia start). The 1 hour buffer is used to account for orders that were drawn prior to surgery but may not have resulted by the time the patient enters the operating room. This will include orders placed by the clinicians working in preoperative assessment clinic and any orders that may be placed by the day of surgery anesthesia or surgical teams. This will not include type and screen orders that have expired by the start of surgery. This is a secondary efficacy outcome that reflects type and screen ordering decisions by all members of the patient's care team.

    Measured: Start of surgery (1 hour after Anesthesia Start)

  2. Frequency of red cell transfusion during surgery

    This is a binary outcome at the patient / surgical case level, which will be aggregated across all patients in the study to produce an overall frequency. Administration of allogeneic packed red blood cells during surgery will be retrieved from the electronic health record. Documentation of transfusion is mandatory and the electronic health record scan is used to confirm the correct patient. This is a secondary efficacy outcome, as lack of a type and screen may prevent discretionary intraoperative transfusion.

    Measured: During surgery

  3. Frequency of emergency release blood use during surgery

    This is a binary outcome at the patient / surgical case level, which will be aggregated across all patients in the study to produce an overall frequency. Administration of emergency release allogeneic packed red blood cells will be retrieved from the electronic health record. These are either documented as volumes under the MTP tab or individually scanned as uncrossmatched red cells. This is the primary safety outcome of the study as emergency release blood may be administered if red cell transfusion is urgently indicated but a type and screen is not available. The frequency of this outcome will be reported overall across both groups, and stratified by whether the patient had an active type and screen at the start of surgery.

    Measured: During surgery

  4. Frequency of red cell transfusion during surgery without an active type and screen at the start of surgery

    This is a binary outcome at the patient / surgical case level, which will be aggregated across all patients in the study to produce an overall frequency. This is the secondary safety outcome intended to capture false negative results, i.e., patients who required transfusion during surgery but did not have a preoperative type and screen. This outcome will be collected electronically from the EHR and will capture patients for whom the type and screen was resulted after the start of surgery (i.e., after 1h after anesthesia start), suggesting it was collected after the patient entered the operating room

    Measured: During surgery

  5. Frequency of transfusion reaction

    This is a binary outcome at the patient / surgical case level, which will be aggregated across all patients in the study to produce an overall frequency. Transfusion reactions are reported by clinical teams to the blood bank, and the transfusion medicine service investigates and classifies each transfusion reaction. These investigation reports will be transmitted to the study team for adverse event reporting and outcome collection. This is also a secondary safety outcome for the study. Transfusion reactions will be reported stratified by category, as hemolytic transfusion reactions are the most relevant to the trial.

    Measured: From time of surgery to hospital discharge or 30 days after surgery

  6. Red cell transfusion during surgery where the preoperative clinic clinician did not order the type and screen but a subsequent clinician did

    This is a secondary safety outcome intended to capture "near-miss" events, where a type and screen was not ordered by the preoperative clinic clinician or would not have been available based on the preoperative clinic clinician's orders, but subsequently another clinician (e.g., day of surgery anesthesia team or surgery team) ordered a type and screen so it was active at the start of surgery, defined with the same 1h after anesthesia start grace period as the main safety outcome. This secondary safety outcome was added at the request of the Data Safety Monitoring Board meeting on July 20, 2026.

    Measured: Day of surgery

Timeline

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

  1. First posted3 Nov 2025
  2. Study start28 Oct 2025
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion1 Jan 2027 (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
Screening
Allocation
Randomised
Intervention model
Crossover
Model description
Stepped-wedge cluster randomized trial
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07223853
Sponsor's protocol ID
202506199
Other IDs
K23HL166880
Acronym
SPATH
Status last verified
Aug 2026
First submitted
28 Oct 2025
Last updated
27 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: For each clinician, the final dataset will include self-reported demographic information, exit interview transcripts, and behavioral and implementation outcomes relating to usage of the proposed clinical decision support (CDS) intervention. For each patient, the final dataset will include clinical and safety outcomes for the study. Trial materials, including consent forms, protocols, and code book for qualitative analysis will also be shared. To anonymize the data, all clinicians and patients will be assigned random identifiers to replace clinician names and patient medical record numbers. No dates for surgical encounters will be retained. All other incidental identifiers (such as mentions of care team member names, encounter numbers, or hospital units) will be stripped.

Publications

  • Yang P, Zijlstra EP, Hall BL, Gregory SH, Jackups R Jr, Li J, Abraham J, Lou SS. Challenges in reliable preoperative blood ordering: A qualitative interview study. Transfusion. 2024 Oct;64(10):1889-1898. doi: 10.1111/trf.18012. Epub 2024 Sep 16.

    PubMed 39279676

  • Lou SS, Liu H, Lu C, Wildes TS, Hall BL, Kannampallil T. Personalized Surgical Transfusion Risk Prediction Using Machine Learning to Guide Preoperative Type and Screen Orders. Anesthesiology. 2022 Jul 1;137(1):55-66. doi: 10.1097/ALN.0000000000004139.

    PubMed 35147666

  • Lou SS, Liu Y, Cohen ME, Ko CY, Hall BL, Kannampallil T. National Multi-Institutional Validation of a Surgical Transfusion Risk Prediction Model. J Am Coll Surg. 2024 Jan 1;238(1):99-105. doi: 10.1097/XCS.0000000000000874. Epub 2023 Sep 22.

    PubMed 37737660

  • Lou SS, Kumar S, Goss CW, Avidan MS, Kheterpal S, Kannampallil T; Multicenter Perioperative Outcomes Group. Multicenter Validation of a Machine Learning Model for Surgical Transfusion Risk at 45 US Hospitals. JAMA Netw Open. 2025 Jun 2;8(6):e2517760. doi: 10.1001/jamanetworkopen.2025.17760.

    PubMed 40577014

Questions about this trial

What is this clinical trial studying?

A study testing S-PATH clinical decision support system in people with Surgery, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: looking for participants now, as of the sponsor's last update on 27 Aug 2026. 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 United States. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sunny S Lou, MD, PhD (314-362-5000, slou@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of patients with a type and screen order placed during the preoperative clinic assessment visit (time frame: Decision made during the preoperative assessment clinic visit). 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 NCT07223853, which also lists 4 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 27 Aug 2026.

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