Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07223853

AI-driven Clinical Decision Support for Perioperative Blood Orders

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University / Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location status: Recruiting

Location contact

Sunny S Lou, MD, PhD

CONTACT

[email protected]

314-362-5000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

S-PATH clinical decision support system

Other

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

Usual Care

Other

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

Primary outcomes

  1. 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

    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.

Secondary outcomes

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

    Time frame: Start of surgery (1 hour after Anesthesia Start)

    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.

  2. Frequency of red cell transfusion during surgery

    Time frame: 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.

  3. Frequency of emergency release blood use during surgery

    Time frame: 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.

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

    Time frame: 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. 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

  5. Frequency of transfusion reaction

    Time frame: From time of surgery to hospital discharge or 30 days after 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. 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.

Other outcomes

  1. Viewing S-PATH predictions (Implementation outcome)

    Time frame: Through study completion, an average of 1 year

    Clinician-level measure of the frequency of viewing S-PATH predictions, retrieved from EHR audit log data

  2. Acceptance of S-PATH recommendation (Implementation outcome)

    Time frame: Through study completion, an average of 1 year

    Clinician-level measure of the frequency of the clinician's blood order during the preoperative clinic visit (1' outcome) matching S-PATH's recommendation

  3. Cost assessment

    Time frame: Through study completion, an average of 1 year

    Estimate of the cost savings associated with S-PATH use

Study contacts

Contact information is provided by the study sponsor or research team.

Sunny S Lou, MD, PhD

CONTACT

[email protected]

314-362-5000

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Acronym: SPATH

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 3, 2025
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.