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Pre-Hospital Use of Plasma for Traumatic Hemorrhage (PUPTH)

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ClinicalTrials.gov Identifier: NCT02303964
Recruitment Status : Withdrawn (Low patient enrollment is the primary reason)
First Posted : December 1, 2014
Last Update Posted : February 23, 2016
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Virginia Commonwealth University

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.


Condition or disease Intervention/treatment Phase
Shock, Hemorrhagic Biological: Plasma Drug: Normal saline Phase 2 Phase 3

Detailed Description:

INVESTIGATIONAL PLAN This will be an open-label, non-blinded, randomized clinical trial to investigate mortality (30 days) and morbidity of Type A thawed Plasma (TP) versus NS infusion at earliest contact, administered by Emergency Medical Service (EMS) supervisors to subjects who have sustained severe Polytrauma / Major hemorrhage (PTr / MH). The total study is expected to last 2 years with 210 patients enrolled.

The two EMS agencies involved in the study will each have one EMS supervisor quick-response vehicle (QRV) equipped with an approved, validated refrigeration unit for TP transport. EMS personnel trained in plasma administration and recognition of reactions may administer up to 2 units of TP to subjects approved for study enrollment. Blood samples for coagulation and lipid testing will be drawn prior to TP administration by EMS personnel,and repeated by hospital personnel at 30 minutes, 8 hours, and 24 hours post-injury.

This study is approved for "Exception from Informed Consent" (EFIC). Once the patient has reached VCUMC and has been entered into the VCUMC health care system, the treating team will advise the Study Coordinator (SC) whether or not a subject is able to consent. As the plasma administration will occur in the field prior to arrival to VCUMC, the SC will make every effort possible to obtain consent from the subject or legally authorized representative (LAR) for continued study participation before the next intervention (8 hour blood specimen collection). The attempts to contact the LAR will be documented in detail. If a subject lacks the ability to provide his/her own consent by the end of day 30, the consent signed by the LAR will be the consent document in force at the subject's completion of the study and no further consent will be sought.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pre-Hospital Use of Plasma for Traumatic Hemorrhage
Study Start Date : November 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Type A Thawed Plasma

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
Type A thawed plasma (up to 2 units) will be administered to polytrauma subjects randomized to plasma arm of study
Other Name: Thawed Plasma

Placebo Comparator: Normal saline
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
Normal saline will be administered to polytrauma subjects randomized to normal saline arm of study
Other Name: 0.9% Normal Saline




Primary Outcome Measures :
  1. Mortality [ Time Frame: 30 day ]
    all cause mortality


Secondary Outcome Measures :
  1. Coagulation function (thromboelastography, RoTEM, Hemodyne, fibrinogen, D-dimer, PFA-100, platelet count, flow cytometry) [ Time Frame: 24 hours ]
    thromboelastography, RoTEM, Hemodyne, fibrinogen, D-dimer, PFA-100, platelet count, flow cytometry

  2. Vital signs (blood pressure, pulse, temperature) [ Time Frame: 24 hours ]
    blood pressure, pulse, temperature

  3. Blood product utilization (number of red blood cell units, number of plasma units, number of platelet units cryoprecipitate doses) [ Time Frame: 30 days ]
    number of red blood cell units, number of plasma units, number of platelet units cryoprecipitate doses

  4. Lipidomic profiles (arachidonic acid, eicosinoid expression, prostacyclin expression) [ Time Frame: 24 hours ]
    arachidonic acid, eicosinoid expression, prostacyclin expression

  5. Blood biochemistry (pH, bicarbonate, lactate) [ Time Frame: 24 hours ]
    pH, bicarbonate, lactate

  6. Hematology (Hemoglobin, hematocrit) [ Time Frame: 24 hours ]
    Hemoglobin, hematocrit

  7. Hospital outcomes (number of cases of multi-system organ failure (MSOF), renal failure, length of hospital stay, length of ICU stay, number of days on a ventilator, number of surgeries, number of infections) [ Time Frame: 30 days ]
    number of cases of multi-system organ failure (MSOF), renal failure, length of hospital stay, length of ICU stay, number of days on a ventilator, number of surgeries, number of infections



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02303964


Locations
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United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
United States Department of Defense
Investigators
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Principal Investigator: Bruce D Spiess, MD, FAHA VCU
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT02303964    
Other Study ID Numbers: HM14813
IND #15910 ( Registry Identifier: FDA )
W81XWH-12-2-0022 ( Other Grant/Funding Number: Department of Defense )
First Posted: December 1, 2014    Key Record Dates
Last Update Posted: February 23, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no data to share.
Keywords provided by Virginia Commonwealth University:
Trauma
Hemorrhage
Plasma
Shock
Polytrauma
Additional relevant MeSH terms:
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Hemorrhage
Shock, Hemorrhagic
Pathologic Processes
Shock