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Shock, HemorrhagicPhase 2/3PUPTHNCT02303964

Pre-Hospital Use of Plasma for Traumatic Hemorrhage

A Phase 2/3 study testing Plasma and Normal saline in people with Shock, Hemorrhagic, run by Virginia Commonwealth University at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Shock, Hemorrhagic
What is being tested?
Plasma and Normal saline
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteUnited States
Study dates
Nov 2014to Jan 2016
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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,
Show all 11Show fewer
  • Cardiac arrest or Cardio-Pulmonary Resuscitation (CPR) prior to randomization
  • Penetrating head trauma,
  • Known / obvious pregnancy,
  • Prisoner,
  • Burns > 20% of body surface

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

Other trials in United States

About this study

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.

Read the 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.

Being tested
Plasma, Normal saline
Keywords
Trauma, Hemorrhage, Plasma, Shock, Polytrauma
Medical subject headings
Shock, Hemorrhagic, Wounds and Injuries, Hemorrhage, Shock, Multiple Trauma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlasmaBiological

    Also called Thawed Plasma

    Type A thawed plasma (up to 2 units) will be administered to polytrauma subjects randomized to plasma arm of study

  • Normal salineDrug

    Also called 0.9% Normal Saline

    Normal saline will be administered to polytrauma subjects randomized to normal saline arm of study

Study groups in NCT02303964
Study groupRoleWhat they receive
Type A Thawed PlasmaActive comparatorEligible 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.
Receives: Biological: Plasma
Normal salinePlacebo comparatorEligible 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
Receives: Drug: Normal saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality

    all cause mortality

    Measured: 30 day

Secondary outcomes (7)

  1. Coagulation function (thromboelastography, RoTEM, Hemodyne, fibrinogen, D-dimer, PFA-100, platelet count, flow cytometry)

    thromboelastography, RoTEM, Hemodyne, fibrinogen, D-dimer, PFA-100, platelet count, flow cytometry

    Measured: 24 hours

  2. Vital signs (blood pressure, pulse, temperature)

    blood pressure, pulse, temperature

    Measured: 24 hours

  3. Blood product utilization (number of red blood cell units, number of plasma units, number of platelet units cryoprecipitate doses)

    number of red blood cell units, number of plasma units, number of platelet units cryoprecipitate doses

    Measured: 30 days

  4. Lipidomic profiles (arachidonic acid, eicosinoid expression, prostacyclin expression)

    arachidonic acid, eicosinoid expression, prostacyclin expression

    Measured: 24 hours

  5. Blood biochemistry (pH, bicarbonate, lactate)

    pH, bicarbonate, lactate

    Measured: 24 hours

  6. Hematology (Hemoglobin, hematocrit)

    Hemoglobin, hematocrit

    Measured: 24 hours

  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)

    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

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2014 (estimated)
  2. Study startNov 2014
  3. Primary completionJan 2016
  4. Study completionJan 2016

Why it stopped: Low patient enrollment is the primary reason

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02303964
Sponsor's protocol ID
HM14813
Other IDs
IND #15910, W81XWH-12-2-0022
Acronym
PUPTH
Status last verified
Feb 2016
First submitted
6 Oct 2014
Last updated
23 Feb 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No: There is no data to share.

Publications

  • 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.

    PubMed 28183347

  • 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.

    PubMed 26220293

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Plasma and Normal saline in people with Shock, Hemorrhagic, run by Virginia Commonwealth University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 23 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality (time frame: 30 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02303964, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2016.

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