Blood Transfusion by Boston MedFlight Registry

The primary aim of this observational registry is to study the outcomes of patients with hemorrhagic shock transported by Boston MedFlight receiving blood products during transport.

Study Overview

• Status: Recruiting
• Conditions: Hemorrhagic Shock

Detailed Description

Boston MedFlight, a critical care transport organization, based on a consortium of the academic medical centers in Boston, will begin carrying PRBC in 2019. The program is intended to provide BMF clinicians with 24-hour immediate access to appropriate blood products to be utilized if needed for patients following life-threatening illness or injury. The four fundamental goals of this program are: save lives' ensure transfusion safety; minimize blood product waste; and conduct continuous quality assurance. Our goal is to observationally evaluate this new protocol of administering blood products in the pre-hospital setting. We will collect data on patients with hemorrhagic shock being transported by Boston MedFlight, who receive or would have been eligible to receive pre-hospital blood transfusion by the inclusion criteria.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Angela Renne; Phone Number: 617-643-2440; Email: ARENNE@MGH.HARVARD.EDU

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Susan R Wilcox, MD; Phone Number: 617-724-1973; Email: SWILCOX1@PARTNERS.ORG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Any patient being transported by Boston MedFlight with hemorrhagic shock

Description

Inclusion criteria:

• Adult patients who would be eligible to receive blood products;

  • systolic blood pressure <90 mmHg
  • a shock index of > 0.9
  • clinical signs of shock as determined by the transport clinicians.

Exclusion Criteria:

• Age < 18 years old

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Blood products during transport; Administration of appropriate blood products during transport
Standard of Care; Receiving standard prehospital air medical care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day mortality	30-day all cause mortality	30 days

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Beth Israel Deaconess Medical Center; Boston Medical Center; Tufts Medical Center; Lahey Clinic; Boston MedFlight
• Investigators: Principal Investigator: Susan R Wilcox, MD, Massachusetts General Hospital and Boston MedFlight

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: October 26, 2020
• First Submitted That Met QC Criteria: October 26, 2020
• First Posted (Actual): November 2, 2020

Study Record Updates

• Last Update Posted (Actual): September 1, 2021
• Last Update Submitted That Met QC Criteria: August 30, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Blood transfusion; Pre-hospital care
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Shock; Shock, Hemorrhagic
• Other Study ID Numbers: 2019P003733

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No