NCT01227005

Brief Summary

The proposal will assess if patients who require massive transfusion can be accurately predicted early after emergency department arrival and assess if the use of stored whole blood during initial resuscitation will reduce transfusion needs compared to transfusion with component therapy and thus improve outcome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
107

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2011

Geographic Reach
1 country

1 active site

Status
completed

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 20, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 22, 2010

Completed
6 months until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

May 28, 2015

Completed
Last Updated

June 4, 2018

Status Verified

May 1, 2018

Enrollment Period

1.3 years

First QC Date

October 20, 2010

Results QC Date

May 19, 2014

Last Update Submit

May 1, 2018

Conditions

Trauma/Injury Problem

Keywords

TransfusionWhole BloodTraumaCoagulopathyComponent TherapyCivilianMilitary

Outcome Measures

Primary Outcomes (1)

  • Units of Blood Products Required During the First 24 Hours After Emergency Department Admission

    Compare the ability of whole blood to reduce initial 24-hour transfusion requirements as compared to component therapy (red blood cells, plasma, and platelet units)

    first 24 hours after ED admission

Secondary Outcomes (2)

  • 24-hour Mortality

    First 24 hours after ED admission

  • 30-day Mortality

    first 30 days after ED admission

Study Arms (2)

Whole Blood

ACTIVE COMPARATOR

Whole Blood plus pooled platelets

Biological: Transfusion of blood products

Component Therapy

ACTIVE COMPARATOR

Red blood cells, plasma, platelets

Biological: Transfusion of blood products

Interventions

Transfusion of blood productsBIOLOGICAL

The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets).

Component TherapyWhole Blood

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older.
  • Meet Code 3 status; Code 3 is determined by the following criteria (Patients must meet at least one of the following physiologic and/or anatomic criteria):
  • Physiologic criteria indicating high risk or life threatening injuries
  • GCS \<10 (Glasgow Coma Scale)
  • SBP \<90 (Systolic blood pressure)
  • RR \<10 or \>29 (Respiratory rate)
  • HR \>120 (Heart rate)
  • intubated
  • Base Deficit \> 6
  • Anatomic criteria indicating high risk or life threatening injuries
  • Any penetrating injury to torso, groin, or neck
  • Amputation proximal to the ankle or wrist
  • Uncontrolled external hemorrhage
  • Two or more long bone fractures
  • Pelvic fracture
  • +3 more criteria

You may not qualify if:

  • Death thought to be imminent, suggesting a futile resuscitation effort
  • Known or assumed religious objection to blood products
  • Do not resuscitate order in place
  • Women who present to the ED who are obviously pregnant.
  • Patients who appear to the ED wearing the -opt-out‖ bracelet provided at the community consultation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Hermann Hospital - Texas Medical Center

Houston, Texas, 77030, United States

Location

Related Publications (6)

  • Erber WN, Tan J, Grey D, Lown JA. Use of unrefrigerated fresh whole blood in massive transfusion. Med J Aust. 1996 Jul 1;165(1):11-3. doi: 10.5694/j.1326-5377.1996.tb124809.x.

    PMID: 8676771BACKGROUND

  • Mohr R, Martinowitz U, Lavee J, Amroch D, Ramot B, Goor DA. The hemostatic effect of transfusing fresh whole blood versus platelet concentrates after cardiac operations. J Thorac Cardiovasc Surg. 1988 Oct;96(4):530-4.

    PMID: 3172799BACKGROUND

  • Oberman HA. The indications for transfusion of freshly drawn blood. JAMA. 1967 Jan 9;199(2):93-7. No abstract available.

    PMID: 5333702BACKGROUND

  • Grosso SM, Keenan JO. Whole blood transfusion for exsanguinating coagulopathy in a US field surgical hospital in postwar Kosovo. J Trauma. 2000 Jul;49(1):145-8. doi: 10.1097/00005373-200007000-00022.

    PMID: 10912871BACKGROUND

  • Ledgerwood AM, Lucas CE. A review of studies on the effects of hemorrhagic shock and resuscitation on the coagulation profile. J Trauma. 2003 May;54(5 Suppl):S68-74. doi: 10.1097/01.TA.0000064513.59253.70.

    PMID: 12768106BACKGROUND

  • Cotton BA, Podbielski J, Camp E, Welch T, del Junco D, Bai Y, Hobbs R, Scroggins J, Hartwell B, Kozar RA, Wade CE, Holcomb JB; Early Whole Blood Investigators. A randomized controlled pilot trial of modified whole blood versus component therapy in severely injured patients requiring large volume transfusions. Ann Surg. 2013 Oct;258(4):527-32; discussion 532-3. doi: 10.1097/SLA.0b013e3182a4ffa0.

    PMID: 23979267DERIVED

MeSH Terms

Conditions

Accidental InjuriesWounds and InjuriesHemostatic Disorders

Interventions

Blood Transfusion

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Limitations and Caveats

First, we failed to specifically exclude patients with severe TBI from our initial protocol. Finally, we did not use an objective scoring system to randomize patients and, therefore, did not always include patients who would have received an MT.

Results Point of Contact

Title
Bryan A. Cotton, MD, MPH
Organization
University of Texas Health Science Center-Houston
bryan.a.cotton@uth.tmc.edu
713-500-7354

Study Officials

  • Bryan Cotton, MD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Surgery

Study Record Dates

First Submitted

October 20, 2010

First Posted

October 22, 2010

Study Start

May 1, 2011

Primary Completion

August 1, 2012

Study Completion

December 1, 2012

Last Updated

June 4, 2018

Results First Posted

May 28, 2015

Record last verified: 2018-05

Locations

US(1)