NCT04610814

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 2, 2020

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

September 1, 2021

Status Verified

August 1, 2021

Enrollment Period

5.1 years

First QC Date

October 26, 2020

Last Update Submit

August 30, 2021

Conditions

Hemorrhagic Shock

Keywords

Blood transfusionPre-hospital care

Outcome Measures

Primary Outcomes (1)

  • 30-day mortality

    30-day all cause mortality

    30 days

Study Arms (2)

Blood products during transport

Administration of appropriate blood products during transport

Standard of Care

Receiving standard prehospital air medical care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any patient being transported by Boston MedFlight with hemorrhagic shock

You may qualify if:

  • 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.

You may not qualify if:

  • Age \< 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Shock, Hemorrhagic

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Susan R Wilcox, MD

    Massachusetts General Hospital and Boston MedFlight

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Angela Renne

CONTACT

617-643-2440ARENNE@MGH.HARVARD.EDU

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Division of Critical Care, Department of Emergency Medicine

Study Record Dates

First Submitted

October 26, 2020

First Posted

November 2, 2020

Study Start

November 1, 2019

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

September 1, 2021

Record last verified: 2021-08

Locations

US(1)