NCT01838863

Brief Summary

Bleeding is the most avoidable cause of death in trauma patients. Up to one-third of severely injured trauma patients are found to be coagulopathic and forty percent of the mortality following severe injury is due to uncontrollable hemorrhage in the setting of coagulopathy. It has been established that early administration of fresh frozen plasma decreases mortality following severe injury, replacing lost coagulation factors, improving the coagulopathy and restoring blood volume. This study will determine if giving plasma to severely injured trauma patients during ambulance transport versus after arrival to the hospital will help reduce hemorrhage, thus decreasing both total blood product administration and mortality.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
144

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2014

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

April 22, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 24, 2013

Completed
12 months until next milestone

Study Start

First participant enrolled

April 7, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2017

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

July 18, 2018

Completed
Last Updated

January 8, 2019

Status Verified

December 1, 2018

Enrollment Period

3 years

First QC Date

April 22, 2013

Results QC Date

March 22, 2018

Last Update Submit

December 15, 2018

Conditions

TraumaHemorrhagic Shock

Keywords

coagulopathyhemorrhagic shockplasmablood product transfusion

Outcome Measures

Primary Outcomes (1)

  • Number of Participants That Died Within 28 Days Post Injury

    death within 28 days post injury (death of any cause except for death due to a second, clearly unrelated traumatic injury suffered after discharge)

    28 days

Secondary Outcomes (8)

  • Composite Outcome of 28-day In-hospital Mortality and Postinjury Multiple Organ Failure (MOF) Incidence

    28 days

  • Admission Coagulopathy

    within 30 minutes of Emergency Department (ED) arrival

  • Number of Participants With Admission Severe Coagulopathy

    within 30 minutes of Emergency Department (ED) arrival

  • Admission Clot Strength

    within 30 minutes of ED arrival

  • Admission Acidosis

    within 30 minutes of ED arrival

  • +3 more secondary outcomes

Other Outcomes (22)

  • Baseline (Field) Coagulation Factor Levels

    after injury and prior to hospital arrival, at about 15 minutes after injury

  • Number of Participants With Abnormal Baseline (Field) Coagulation Factor XIII Level

    after injury prior to hospital arrival

  • Admission (First Arrival) Coagulation Factor Levels

    after injury prior to hospital arrival

  • +19 more other outcomes

Study Arms (2)

Plasma

EXPERIMENTAL

If the patient is randomized to experimental arm, 2 units of frozen type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the type AB plasma is ready, and will continue during transport to the emergency department (ED). After infusion of 2 units of type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by the hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.

Biological: Type AB plasma

Standard

ACTIVE COMPARATOR

If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute packed red blood cells pRBC administration determined by the hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.

Drug: Crystalloid fluid (standard of care for resuscitation)

Interventions

Type AB plasmaBIOLOGICAL

The plasma is thawed and administered to subjects in the experimental (plasma) arm.

Also known as: Plasma frozen within 24 hours (FP24, PF24)
Plasma
Crystalloid fluid (standard of care for resuscitation)DRUG

Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid

Also known as: Normal saline
Standard

Eligibility Criteria

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

You may qualify if:

  • Age\>=18 years
  • Acutely injured
  • SBP\<70 mmHg or SBP 71-90 mmHg with heart rate (HR)\>108 beats per minute.

You may not qualify if:

  • Visibly or verbally reported pregnant women
  • known prisoners
  • unsalvageable injuries (defined as asystolic or cardiopulmonary resuscitation prior to randomization)
  • known objection to blood products
  • the patient has an opt-out bracelet or, necklace or wallet card
  • a family member present at the scene objects to the patient's enrollment in research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Denver Health Medical Center

Denver, Colorado, 80204, United States

Location

Related Publications (5)

  • DeBot M, Erickson C, Schaid T, LaCroix I, Moore EE, Silliman C, Cohen MJ, D'Alessandro A, Hansen KC. Trauma-induced dysfibrinogenemia: the von Clauss assay does not accurately measure fibrinogen levels after injury. Blood Vessel Thromb Hemost. 2024 Jul 16;1(3):100017. doi: 10.1016/j.bvth.2024.100017. eCollection 2024 Sep.

    PMID: 40766812DERIVED

  • Pusateri AE, Moore EE, Moore HB, Le TD, Guyette FX, Chapman MP, Sauaia A, Ghasabyan A, Chandler J, McVaney K, Brown JB, Daley BJ, Miller RS, Harbrecht BG, Claridge JA, Phelan HA, Witham WR, Putnam AT, Sperry JL. Association of Prehospital Plasma Transfusion With Survival in Trauma Patients With Hemorrhagic Shock When Transport Times Are Longer Than 20 Minutes: A Post Hoc Analysis of the PAMPer and COMBAT Clinical Trials. JAMA Surg. 2020 Feb 1;155(2):e195085. doi: 10.1001/jamasurg.2019.5085. Epub 2020 Feb 19.

    PMID: 31851290DERIVED

  • Moore HB, Moore EE, Chapman MP, McVaney K, Bryskiewicz G, Blechar R, Chin T, Burlew CC, Pieracci F, West FB, Fleming CD, Ghasabyan A, Chandler J, Silliman CC, Banerjee A, Sauaia A. Plasma-first resuscitation to treat haemorrhagic shock during emergency ground transportation in an urban area: a randomised trial. Lancet. 2018 Jul 28;392(10144):283-291. doi: 10.1016/S0140-6736(18)31553-8. Epub 2018 Jul 20.

    PMID: 30032977DERIVED

  • 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

  • Chapman MP, Moore EE, Chin TL, Ghasabyan A, Chandler J, Stringham J, Gonzalez E, Moore HB, Banerjee A, Silliman CC, Sauaia A. Combat: Initial Experience with a Randomized Clinical Trial of Plasma-Based Resuscitation in the Field for Traumatic Hemorrhagic Shock. Shock. 2015 Aug;44 Suppl 1(0 1):63-70. doi: 10.1097/SHK.0000000000000376.

    PMID: 25784527DERIVED

MeSH Terms

Conditions

Wounds and InjuriesShock, HemorrhagicHemostatic Disorders

Interventions

Standard of CareResuscitationSaline Solution

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsShockVascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and EvaluationEmergency TreatmentTherapeuticsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Results Point of Contact

Title
Dr. Ernest E. Moore
Organization
Denver Health Medical Center
Ernest.Moore@dhha.org
303.602.1820

Study Officials

  • Ernest E Moore, MD

    Denver Health Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Vice Chair, Department of Surgery

Study Record Dates

First Submitted

April 22, 2013

First Posted

April 24, 2013

Study Start

April 7, 2014

Primary Completion

April 3, 2017

Study Completion

April 3, 2017

Last Updated

January 8, 2019

Results First Posted

July 18, 2018

Record last verified: 2018-12

Locations

US(1)