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NCT04610814 Clinical Trial

Blood Transfusion by Boston MedFlight Registry

Hemorrhagic Shock Clinical Trial

Official title:
Blood Transfusion by Boston MedFlight Registry

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04610814
Other study ID # 2019P003733
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2019
Est. completion date December 2024

Study information
Verified date August 2021
Source Massachusetts General Hospital
Contact Angela Renne
Phone 617-643-2440
Email ARENNE@MGH.HARVARD.EDU
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (6)
Lead Sponsor Collaborator
Massachusetts General Hospital Beth Israel Deaconess Medical Center, Boston MedFlight, Boston Medical Center, Lahey Clinic, Tufts Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 30-day mortality 30-day all cause mortality 30 days
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