Clinical trial NCT02303964: Pre-Hospital Use of Plasma for Traumatic Hemorrhage
Official title: Pre-Hospital Use of Plasma for Traumatic Hemorrhage
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Shock, Hemorrhagic
Keywords: Trauma
Hemorrhage
Plasma
Shock
Polytrauma
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2014-12-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Mortality
timeFrame: 30 day
Secondary outcomes:
measure: Coagulation function (thromboelastography, RoTEM, Hemodyne, fibrinogen, D-dimer, PFA-100, platelet count, flow cytometry)
timeFrame: 24 hours
measure: Vital signs (blood pressure, pulse, temperature)
timeFrame: 24 hours
measure: Blood product utilization (number of red blood cell units, number of plasma units, number of platelet units cryoprecipitate doses)
timeFrame: 30 days
measure: Lipidomic profiles (arachidonic acid, eicosinoid expression, prostacyclin expression)
timeFrame: 24 hours
measure: Blood biochemistry (pH, bicarbonate, lactate)
timeFrame: 24 hours
measure: Hematology (Hemoglobin, hematocrit)
timeFrame: 24 hours
measure: 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)
timeFrame: 30 days
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: VCU
name: Bruce D Spiess, MD, FAHA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.