PUPTH: Pre-Hospital Use of Plasma for Traumatic Hemorrhage

Sponsor

Virginia Commonwealth University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02303964

Collaborator

United States Department of Defense (U.S. Fed)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

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 :

Nov 1, 2014

Actual Primary Completion Date :

Jan 1, 2016

Actual Study Completion Date :

Jan 1, 2016

Arms and Interventions

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 Names: 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 Names: 0.9% Normal Saline

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 Names:

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 Names:

0.9% Normal Saline

Outcome Measures

Primary Outcome Measures

Mortality [30 day]
all cause mortality

Secondary Outcome Measures

Coagulation function (thromboelastography, RoTEM, Hemodyne, fibrinogen, D-dimer, PFA-100, platelet count, flow cytometry) [24 hours]
thromboelastography, RoTEM, Hemodyne, fibrinogen, D-dimer, PFA-100, platelet count, flow cytometry
Vital signs (blood pressure, pulse, temperature) [24 hours]
blood pressure, pulse, temperature
Blood product utilization (number of red blood cell units, number of plasma units, number of platelet units cryoprecipitate doses) [30 days]
number of red blood cell units, number of plasma units, number of platelet units cryoprecipitate doses
Lipidomic profiles (arachidonic acid, eicosinoid expression, prostacyclin expression) [24 hours]
arachidonic acid, eicosinoid expression, prostacyclin expression
Blood biochemistry (pH, bicarbonate, lactate) [24 hours]
pH, bicarbonate, lactate
Hematology (Hemoglobin, hematocrit) [24 hours]
Hemoglobin, hematocrit
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) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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