Blood Transfusion by Boston MedFlight Registry

NCT ID: NCT04610814

Last Updated: 2021-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-01

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hemorrhagic Shock

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Blood products during transport

Administration of appropriate blood products during transport

No interventions assigned to this group

Standard of Care

Receiving standard prehospital air medical care

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston MedFlight

UNKNOWN

Sponsor Role collaborator

Boston Medical Center

OTHER

Sponsor Role collaborator

Tufts Medical Center

OTHER

Sponsor Role collaborator

Lahey Clinic

OTHER

Sponsor Role collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Susan Renee Wilcox

Chief, Division of Critical Care, Department of Emergency Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Susan R Wilcox, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital and Boston MedFlight

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Angela Renne

Role: CONTACT

617-643-2440

Facility Contacts

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Susan R Wilcox, MD

Role: primary

617-724-1973

Other Identifiers

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2019P003733

Identifier Type: -

Identifier Source: org_study_id

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