NCT02303964

Brief Summary

Type A Thawed Plasma (TP) will be compared in polytrauma patients who receive only Normal Saline (NS) (standard of care) before arrival at the hospital. The purpose of this study is to determine if prehospital administration of thawed plasma can reduce mortality of patients who have lost a large amount of blood due to their injuries, compared to those receiving standard of care.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

October 6, 2014

Completed
26 days until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

February 23, 2016

Status Verified

February 1, 2016

Enrollment Period

1.2 years

First QC Date

October 6, 2014

Last Update Submit

February 19, 2016

Conditions

Shock, Hemorrhagic

Keywords

TraumaHemorrhagePlasmaShockPolytrauma

Outcome Measures

Primary Outcomes (1)

  • Mortality

    all cause mortality

    30 day

Secondary Outcomes (7)

  • Coagulation function (thromboelastography, RoTEM, Hemodyne, fibrinogen, D-dimer, PFA-100, platelet count, flow cytometry)

    24 hours

  • Vital signs (blood pressure, pulse, temperature)

    24 hours

  • Blood product utilization (number of red blood cell units, number of plasma units, number of platelet units cryoprecipitate doses)

    30 days

  • Lipidomic profiles (arachidonic acid, eicosinoid expression, prostacyclin expression)

    24 hours

  • Blood biochemistry (pH, bicarbonate, lactate)

    24 hours

  • +2 more secondary outcomes

Study Arms (2)

Type A Thawed Plasma

ACTIVE COMPARATOR

Eligible subjects with polytrauma (PT) and major hemorrhage (MH) will be randomized to receive 2 units of thawed Type A plasma in the pre-hospital setting administered by EMS first responders. An exception from informed consent under 21CFR 50.24 is required since enrollment will occur (for the majority of subjects) before consent can be obtained.

Biological: Plasma

Normal saline

PLACEBO COMPARATOR

Eligible subjects with polytrauma (PT) and major hemorrhage (MH) will be randomized to receive normal saline in the pre-hospital setting administered by EMS first responders. Normal saline is standard of care

Drug: Normal saline

Interventions

PlasmaBIOLOGICAL

Type A thawed plasma (up to 2 units) will be administered to polytrauma subjects randomized to plasma arm of study

Also known as: Thawed Plasma
Type A Thawed Plasma
Normal salineDRUG

Normal saline will be administered to polytrauma subjects randomized to normal saline arm of study

Also known as: 0.9% Normal Saline
Normal saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Blunt or penetrating trauma,
  • Blood Pressure (BP) systolic \<70 mmHg or BP 70-90 mmHg with Heart Rate (HR) \> 108 Beats Per Minute (BPM),
  • Ongoing hemorrhage with unstable vital signs

You may not qualify if:

  • Wearing opt-out wrist band,
  • Wearing medical alert jewelry / bracelet, etc. indicating Jehovah Witness or similar with objections to blood transfusions,
  • Refusal to participate (by subject or LAR),
  • Communication barrier at the time of eliciting refusal (non-English speaking or non-Spanish speaking),
  • Not expected to survive transport to Virginia Commonwealth University Medical Center (VCUMC),
  • Documented Do Not Resuscitate (DNR) order found,
  • Cardiac arrest or Cardio-Pulmonary Resuscitation (CPR) prior to randomization
  • Penetrating head trauma,
  • Known / obvious pregnancy,
  • Prisoner,
  • Burns \> 20% of body surface

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (2)

  • Reynolds PS, Michael MJ, Spiess BD. Application of Incident Command Structure to clinical trial management in the academic setting: principles and lessons learned. Trials. 2017 Feb 9;18(1):62. doi: 10.1186/s13063-016-1755-9.

    PMID: 28183347DERIVED

  • Reynolds PS, Michael MJ, Cochran ED, Wegelin JA, Spiess BD. Prehospital use of plasma in traumatic hemorrhage (The PUPTH Trial): study protocol for a randomised controlled trial. Trials. 2015 Jul 30;16:321. doi: 10.1186/s13063-015-0844-5.

    PMID: 26220293DERIVED

MeSH Terms

Conditions

Shock, HemorrhagicWounds and InjuriesHemorrhageShockMultiple Trauma

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Bruce D Spiess, MD, FAHA

    VCU

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2014

First Posted

December 1, 2014

Study Start

November 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

February 23, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

There is no data to share.

Locations

US(1)