Trauma/Injury ProblemPhase 4NCT01227005
Early Whole Blood in Patients Requiring Transfusion After Major Trauma
A Phase 4 study testing Transfusion of blood products in people with Trauma/Injury Problem, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Trauma/Injury Problem
- What is being tested?
- Transfusion of blood products
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Dec 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 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)
Show all 18Show fewer
- 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
- Paraplegia or quadriplegia
- Combination trauma with burns ≥ 20% BSA (body surface area)
- Demonstrate evidence of blood loss due to injury, requiring transfusion in the ED.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Hermann Hospital - Texas Medical Center
Houston, Texas, 77030
About this study
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.
Read the detailed description
Background: The acquired coagulopathy of trauma is responsible for a large percentage of early deaths in civilian trauma practice and is a major cause of battlefield mortality. Widespread recognition has provided a rationale for fundamental changes in the initial management of severely injured patients through prevention of hypothermia, damage control surgery, massive transfusion protocols and early triage to intensive care units for optimized resuscitation. Despite these major advances, hemorrhage remains a leading cause of early death in both civilian trauma and military combat casualty care. However, it is unclear how early whole blood will affect coagulopathy in this cohort of patients as compared to the current standard of care. Objective/Hypothesis: 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.
Study Design: As a first step in testing this hypothesis, we will test commonly utilized point of care analysis devices and determine their reliability in predicting transfusion requirements in severely injured trauma patients within 20 minutes after arrival in the emergency department. Furthermore, we will prospectively randomize severely injured patients who require a blood transfusion to receive either stored whole blood and pooled platelets or component therapy (packed red blood cells, fresh frozen plasma, and platelets, our current standard of care) and compare the ability of stored whole blood to reduce transfusion needs and improve clinical outcomes.
Relevance: Severe uncontrollable coagulopathy in major trauma patients continues to be a major determinant of trauma mortalities. The proposed effort aims to provide an early, coagulopathy-based prediction model to identify patients at risk for massive transfusion. Moreover, our proposal intends to evaluate early stored whole blood transfusion in this at risk patient population and determine stored whole blood's ability to prevent or control severe coagulopathy compared to standard transfusion care.
- Conditions
- Trauma/Injury Problem
- Being tested
- Transfusion of blood products
- Keywords
- Transfusion, Whole Blood, Trauma, Coagulopathy, Component Therapy, Civilian, Military
- Medical subject headings
- Accidental Injuries, Wounds and Injuries, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| Whole Blood | Active comparator | Whole Blood plus pooled platelets Receives: Biological: Transfusion of blood products |
| Component Therapy | Active comparator | Red blood cells, plasma, platelets Receives: Biological: Transfusion of blood products |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: first 24 hours after ED admission
Secondary outcomes (2)
24-hour Mortality
Mortality rate at 24 hours after arrival
Measured: First 24 hours after ED admission
30-day Mortality
Evaluate 30-day mortality among those receiving whole blood compared to those receiving component therapy
Measured: first 30 days after ED admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2010 (estimated)
- Study startMay 2011
- Primary completionAug 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Trauma/Injury ProblemStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Responsible party
- Principal investigator, Bryan Cotton, The University of Texas Health Science Center, Houston
- Investigators
- Bryan Cotton, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01227005
- Sponsor's protocol ID
- W81XWH-07-1-0229
- Status last verified
- May 2018
- First submitted
- 20 Oct 2010
- Last updated
- 4 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 8676771Mohr 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.
PubMed 3172799Oberman HA. The indications for transfusion of freshly drawn blood. JAMA. 1967 Jan 9;199(2):93-7. No abstract available.
PubMed 5333702Grosso 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.
PubMed 10912871Ledgerwood 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.
PubMed 12768106Cotton 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.
PubMed 23979267
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Whole Blood in Patients Requiring Transfusion After Major Trauma
- ClinicalTrials.gov ID
- NCT01227005
- Acronym / sponsor ID
- W81XWH-07-1-0229
- Conditions
- Trauma/Injury Problem
- Keywords
- Transfusion, Whole Blood, Trauma, Coagulopathy, Component Therapy, Civilian, Military
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Study start
- May 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 22 Oct 2010 (estimated)
- Results
- Posted 28 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: The acquired coagulopathy of trauma is responsible for a large percentage of early deaths in civilian trauma practice and is a major cause of battlefield mortality. Widespread recognition has provided a rationale for fundamental changes in the initial management of severely injured patients through prevention of hypothermia, damage control surgery, massive transfusion protocols and early triage to intensive care units for optimized resuscitation. Despite these major advances, hemorrhage remains a leading cause of early death in both civilian trauma and military combat casualty care. However, it is unclear how early whole blood will affect coagulopathy in this cohort of patients as compared to the current standard of care. Objective/Hypothesis: 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.
Study Design: As a first step in testing this hypothesis, we will test commonly utilized point of care analysis devices and determine their reliability in predicting transfusion requirements in severely injured trauma patients within 20 minutes after arrival in the emergency department. Furthermore, we will prospectively randomize severely injured patients who require a blood transfusion to receive either stored whole blood and pooled platelets or component therapy (packed red blood cells, fresh frozen plasma, and platelets, our current standard of care) and compare the ability of stored whole blood to reduce transfusion needs and improve clinical outcomes.
Relevance: Severe uncontrollable coagulopathy in major trauma patients continues to be a major determinant of trauma mortalities. The proposed effort aims to provide an early, coagulopathy-based prediction model to identify patients at risk for massive transfusion. Moreover, our proposal intends to evaluate early stored whole blood transfusion in this at risk patient population and determine stored whole blood's ability to prevent or control severe coagulopathy compared to standard transfusion care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole Blood | Active comparator | Biological: Transfusion of blood productsWhole Blood plus pooled platelets |
| Component Therapy | Active comparator | Biological: Transfusion of blood productsRed blood cells, plasma, platelets |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 18 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):
- Demonstrate evidence of blood loss due to injury, requiring transfusion in the ED.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transfusion of blood productsThe 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). | Biological | Component Therapy, Whole Blood |
Primary outcome
Units of Blood Products Required During the First 24 Hours After Emergency Department Admission
Time frame: first 24 hours after ED 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)
2 secondary outcomes
24-hour Mortality
Time frame: First 24 hours after ED admission
30-day Mortality
Time frame: first 30 days after ED admission
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 8676771Erber 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.
- Background: PubMed 3172799Mohr 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.
- Background: PubMed 5333702Oberman HA. The indications for transfusion of freshly drawn blood. JAMA. 1967 Jan 9;199(2):93-7. No abstract available.
- Background: PubMed 10912871Grosso 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.
- Background: PubMed 12768106Ledgerwood 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.
- Derived from this study: PubMed 23979267Cotton 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bryan Cotton, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Transfusion of blood products in people with Trauma/Injury Problem, run by The University of Texas Health Science Center, Houston 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 18 inclusion and 5 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: finished, as of the sponsor's last update on 4 Jun 2018. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Units of Blood Products Required During the First 24 Hours After Emergency Department Admission (time frame: first 24 hours after ED admission). 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 NCT01227005, which also lists 6 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 4 Jun 2018.