Recruiting

Observational Study

Sponsor:

Massachusetts General Hospital

Code:

NCT04610814

Conditions

Hemorrhagic Shock

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Hemorrhagic Shock

Study ID

NCT04610814

Start date

Nov 1, 2019

Status verified date

Aug, 2021

Completion date

Dec, 2024

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Blood products during transport

Administration of appropriate blood products during transport

Standard of Care

Receiving standard prehospital air medical care

Primary outcome measure

  • 30-day mortality [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Angela Renne

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

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Susan R Wilcox, MD

617-724-1973SWILCOX1@PARTNERS.ORG

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Sep 1, 2021

Last verified

Aug, 2021

Keywords

  • Blood transfusion
  • Pre-hospital care

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2021-09-01.