Shock, TraumaticPhase 3NCT00316017

Hypertonic Resuscitation Following Traumatic Injury

A Phase 3 study testing 7.5% hypertonic saline/6% Dextran-70 (HSD), 7.5% hypertonic saline (HS) and 0.9% normal saline in people with Shock, Traumatic, run by University of Washington at 10 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study is to determine if hypertonic saline with and without dextran can improve overall survival in victims of trauma with shock. Injury and lost blood from trauma can cause your body to be in shock (low blood pressure related to blood loss). This decreased blood flow can lead to organ damage. Read more about this study

Who is it for?: Ages 15 years and older
Conditions the study is for: Shock, Traumatic
What is being tested?: 7.5% hypertonic saline/6% Dextran-70 (HSD), 7.5% hypertonic saline (HS) and 0.9% normal saline
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 895 participants
Where: 10 sitesin 2 countries
Study dates: May 2006to Aug 2009
Phase: Phase 3
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 15 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Blunt or penetrating trauma
Prehospital Systolic Blood Pressure (SBP) <= 70;OR
Prehospital SBP 71-90 AND Hear Rate (HR) ≥108
15 years of age or older, or 50kg or more if age unknown

Who cannot join

Known or suspected pregnancy
Age younger than 15 or less than 50kg if age unknown
Ongoing prehospital cardiopulmonary resuscitation (CPR)
Administration of more than 2000cc crystalloid or any colloid or blood products
Severe hypothermia (suspected Temperature less than 28 degrees celsius)
Drowning or asphyxia due to hanging

Show all 11Show fewer

Burns Total Body Surface Area (TBSA) more than 20%
Isolated penetrating injury to the head
Inability to obtain prehospital intravenous access
Time of call received at dispatch to study intervention greater than four hours
Known prisoners

Trial locations and contacts

10 sites in 2 countries.

Country

City, postcode or hospital

10 sites in 2 countries

United States8 sites

Alabama Resuscitaion Center, University of Alabama
Birmingham, Alabama, 35249
Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Iowa Resuscitation Network, University of Iowa Carver College of Medicine
Iowa City, Iowa, 52242
Milwaukee Resuscitation Network, Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
The Pittsburgh Resuscitation Network, University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Portland Resuscitation Outcomes Consortium, Oregon Health & Sciences University
Portland, Oregon, 97239
UCSD-San Diego Resuscitation Research Center
San Diego, California, 92103
Seattle-King County Center For Resuscitation Research, University of Washington
Seattle, Washington, 98195

Other trials in United States

Canada2 sites

University of Ottawa/University of British Columbia Collaborative RCC, Ottawa Health Research Institute
Ottawa, Ontario, K1Y4E9
Toronto Regional Resuscitation Research Out-of-Hospital Network, University of Toronto
Toronto, Ontario, M5B1W8

Other trials in Canada

About this study

Official title: Phase 3 Study of Hypertonic Resuscitation Following Traumatic Injury With Hypovolemic Shock

The purpose of this study is to determine if hypertonic saline with and without dextran can improve overall survival in victims of trauma with shock.

Injury and lost blood from trauma can cause your body to be in shock (low blood pressure related to blood loss). This decreased blood flow can lead to organ damage. In order to restore the blood pressure and blood flow, the medics give fluids into the patients' veins as soon as possible. This is called "resuscitation." The resuscitation fluid most commonly used is "isotonic" or one that is the same concentration as the blood. The investigators are trying to determine if infusing a "hypertonic" fluid (or one more concentrated than the blood) can increase the blood pressure and restore blood flow more efficiently. The hypertonic fluids the investigators are using are called hypertonic saline with dextran (HSD) and hypertonic saline (no dextran). Hypertonic saline is a salt solution that is slightly more concentrated than your blood. Dextran is a sugar solution.

Read the detailed description

Specific Aim: To determine if prehospital administration of 7.5% hypertonic saline /6% Dextran-70 (HSD) OR 7.5% hypertonic saline alone (HS), compared to current standard therapy with normal saline (NS), as an initial resuscitation fluid, affects survival following traumatic injury with hypovolemic shock.

Trauma is the leading cause of death among North Americans between the ages of 1 and 44 years. The majority of these deaths result from hypovolemic shock or severe brain injury. Patients in hypovolemic shock develop a state of systemic tissue ischemia then a subsequent reperfusion injury at the time of fluid resuscitation. Conventional resuscitation involves the IV administration of a large volume of isotonic or slightly hypotonic (lactated ringers, LR) solutions beginning in the prehospital setting. Although not conclusive, prior studies have suggested that alternative resuscitation with hypertonic saline (7.5%) solutions may reduce morbidity or mortality in these patients. Furthermore, hypertonic fluids may have specific advantages in the brain-injured patient, as they may aid in the rapid restoration of cerebral perfusion and prevent extravascular fluid sequestration, thereby limiting secondary brain injury. In addition, recent studies have demonstrated that hypertonicity significantly alters the activation of inflammatory cells, an effect that may reduce subsequent organ injury from ischemia-reperfusion and decrease nosocomial infection. The majority of previous clinical trials have focused on the use of HSD. The potential for 7.5% saline alone (HS) to have similar effects has not been well studied. Removal of the dextran component may enhance the anti-inflammatory effects of this solution, which could improve secondary outcomes such as acute respiratory distress syndrome (ARDS), multiple organ failure syndrome (MOFS) and rates of nosocomial infections.

This study is a randomized, double-blind, three-arm placebo controlled trial designed to evaluate the clinical outcome of trauma patients with hypovolemic shock, as manifested by prehospital hypotension. Patients will be randomized to a single 250cc IV dose of 7.5% saline in 6% Dextran-70 (HSD), 7.5% saline (HS) or normal saline as the initial fluid for prehospital resuscitation. No additional interventions will occur once the patient is admitted to the hospital. In hospital data collection will last up to 28 days.

Conditions: Shock, Traumatic
Being tested: 7.5% hypertonic saline/6% Dextran-70 (HSD), 7.5% hypertonic saline (HS), 0.9% normal saline
Keywords: Trauma, Shock
Medical subject headings: Shock, Traumatic, Wounds and Injuries, Shock

What participants receive

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

7.5% hypertonic saline/6% Dextran-70 (HSD)Drug
Also called RescueFlo
250 cc dose given as a one-time intravenous (IV) bolus in the pre-hospital setting.
7.5% hypertonic saline (HS)Drug
250 cc dose given as a one-time IV bolus in the pre-hospital setting.
0.9% normal salineDrug
250 cc dose given as a one-time IV bolus in the pre-hospital setting.

Study groups in NCT00316017
Study group	Role	What they receive
1	Experimental	7.5% hypertonic saline/6% Dextran-70 (HSD) Receives: Drug: 7.5% hypertonic saline/6% Dextran-70 (HSD)
2	Experimental	7.5% hypertonic saline (HS) Receives: Drug: 7.5% hypertonic saline (HS)
3	Placebo comparator	0.9% normal saline Receives: Drug: 0.9% normal saline

What is being measured

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

28 Day Survival
The day of episode is counted as "Day 0". So for measures using a 28 day period, the maximum value is 29 (i.e. days 0 through 28).
Measured: 28 days from time of Emergency Department (ED) arrival

Secondary outcomes (21)

Adult Respiratory Distress Syndrome(ARDS)-Free Survival Through Day 28
Absence of diagnosis of Adult Respiratory Distress Syndrome and alive through day 28
Measured: 28 days from time of ED arrival
Worst Multiple Organ Dysfunction Score (MODS) Mean Through Day 28
Multiple Organ Dysfunction Score is described as:
Six organ systems were chosen, and a score of 0-4 allotted for each organ according to function (0 being normal function through to 4 for most severe dysfunction) with a maximum score of 24. The worst score based on available data (missing values were assumed normal) in each 24-hour period is taken for calculation of the aggregate score.
Measured: 28 days from time of ED arrival
Presence of Nosocomial Infection Through Day 28
Includes one or more nosocomial infections from the following list: pneumonia, blood stream infection, urinary tract infection and wound infection
Measured: Within 28 days of injury, while hospitalized
Packed Red Blood Cells (PRBC) First 24 Hours
The numbers of units of packed red blood cells transfused in the first 24 hours
Measured: First 24 hours from the time of 911 call
Total Fluids First 24 Hours
The total amount of IV fluids given in the pre-hospital setting and the hospital setting in the first 24 hours following the time of 911 call
Measured: First 24 hours from the time of of 911 call
Ventilator-free Days Through Day 28
The number of days beginning with the day of 911 call counted as "Day O" through day 28 that the patient did not require mechanical ventilation
Measured: Duration of hospital stay through day 28
Days Alive Out of the Intensive Care Unit (ICU) Through Day 28
The number of days the patient is alive and not being cared for in the intensive care unit
Measured: First 28 days from the time of 911 call
Days Alive Out of the Hospital Through Day 28
The number of days the patient is alive and no longer an inpatient in the hospital through day 28
Measured: First 28 days from the time of 911 call
Survival at Hospital Discharge
Alive at the time of discharge from the Level One or Two trauma hospital. This did not include disposition from rehabilitation facilities.
Measured: Duration of hospital stay through to discharge
Zero Units PRBC in First 24 Hours
This is the total number of subjects who received no blood products in the first 24 hours from the time of the 911 call.
Measured: From the time dispatch received the 911 call to the end of the first 24 hours
Zero Units PRBC and Died in Field or Emergency Department (ED)
This is the total number of subjects who died in the field or the ED from the set of subjects who received no blood products.
Measured: From the time dispatch received 911 call to the time of death in the field or ED
Zero Units PRBC and Died Within 6 Hours of Admission to the Hospital
This is the total number of subjects who died within the first 6 hours from the time of admission to the hospital among the patients who received no blood products.
Measured: The first 6 hours from the time of admission to the hospital
Zero Units PRBC and Died Within 28 Days From the Time of the 911 Call
This is the total number of subjects who died within 28 days from the time of the 911 call among the patients who received no units of PRBC.
Measured: From the time dispatch received the 911 call to 28 days
1-9 Units PRBC in First 24 Hours
This is the total number of subjects who received 1 to 9 units of packed red blood cells (PRBC) in the first 24 hours from the time of the 911 call.
Measured: From the time dispatch received the 911 call to the end of the first 24 hours
1-9 Units PRBC and Died in Field or ED
This is the total number of subjects who received 1 to 9 units of packed red blood cells (PRBC) among the patients who died in the field or the ED.
Measured: From the time dispatch received 911 call to the time of death in the field or ED
1-9 Units PRBC and Died Within 6 Hours of Admission to the Hospital
This is the total number of subjects who died within the first 6 hours from the time of admission to the hospital among the patients who received 1 to 9 units of packed red blood cells (PRBC).
Measured: The first 6 hours from the time of admission to the hospital
1-9 Units PRBC and Died Within 28 Days From the Time of the 911 Call
This is the total number of subjects who died within 28 days from the time of the 911 call among the patients who received 1 to 9 units of packed red blood cells (PRBC).
Measured: From the time dispatch received the 911 call to 28 days
Greater Than 10 Units PRBC in First 24 Hours
This is the total number of subjects who received greater than 10 units of packed red blood cells (PRBC) in the first 24 hours from the time of the 911 call.
Measured: From the time dispatch received the 911 call to the end of the first 24 hours
Greater Than 10 Units PRBC and Died in Field or ED
This is the total number of subjects who died in the field or the ED among the patients who received greater than 10 units of packed red blood cells (PRBC).
Measured: From the time dispatch received 911 call to the time of death in the field or ED
Greater Than 10 Units PRBC and Died Within 6 Hours of Admission to the Hospital
This is the total number of subjects who died within the first 6 hours from the time of admission to the hospital among the patients who received greater than 10 units of packed red blood cells (PRBC).
Measured: The first 6 hours from the time of admission to the hospital
Greater Than 10 Units PRBC and Died Within 28 Days From the Time of the 911 Call
This is the total number of subjects who died within 28 days from the time of the 911 call among the patients who received greater than 10 units of packed red blood cells (PRBC).
Measured: From the time dispatch received the 911 call to 28 days

Timeline

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

May 2006Aug 2009

First posted19 Apr 2006 (estimated)
Study startMay 2006
Primary completionAug 2009
Study completionAug 2009

Why it stopped: Futility \& potential safety concern (increased early mortality in the HS/HSD arms for those with no PRBC in 1st 24 hr, post-randomization subgp)

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 (2)Papers the sponsor has linked to this study.
Other trials for Shock, TraumaticStudies of the same condition, open and under way.
More trials run by University of WashingtonThe 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 895 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00316017
Sponsor's protocol ID: 28226-A - IND 12506
Other IDs: 5U01HL077863-05, IND #12506 (shock cohort)
Status last verified: Feb 2011
First submitted: 17 Apr 2006
Last updated: 1 Mar 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Bulger EM, May S, Kerby JD, Emerson S, Stiell IG, Schreiber MA, Brasel KJ, Tisherman SA, Coimbra R, Rizoli S, Minei JP, Hata JS, Sopko G, Evans DC, Hoyt DB; ROC investigators. Out-of-hospital hypertonic resuscitation after traumatic hypovolemic shock: a randomized, placebo controlled trial. Ann Surg. 2011 Mar;253(3):431-41. doi: 10.1097/SLA.0b013e3181fcdb22.
PubMed 21178763
Tisherman SA, Schmicker RH, Brasel KJ, Bulger EM, Kerby JD, Minei JP, Powell JL, Reiff DA, Rizoli SB, Schreiber MA. Detailed description of all deaths in both the shock and traumatic brain injury hypertonic saline trials of the Resuscitation Outcomes Consortium. Ann Surg. 2015 Mar;261(3):586-90. doi: 10.1097/SLA.0000000000000837.
PubMed 25072443

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Shock, Traumatic trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 3 Study of Hypertonic Resuscitation Following Traumatic Injury With Hypovolemic Shock
ClinicalTrials.gov ID: NCT00316017
Acronym / sponsor ID: 28226-A - IND 12506
Conditions: Shock, Traumatic
Keywords: Trauma, Shock
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Futility \& potential safety concern (increased early mortality in the HS/HSD arms for those with no PRBC in 1st 24 hr, post-randomization subgp)
Enrolment: 895 participants (actual)
Lead sponsor: University of WashingtonUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI), National Institute of Neurological Disorders and Stroke (NINDS), The Institute of Circulatory and Respiratory Health (ICRH), Defence Research and Development Canada
Study start: May 2006
Primary completion: Aug 2009 (actual)
Study completion: Aug 2009 (actual)
First posted: 19 Apr 2006 (estimated)
Results: Posted 11 Nov 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to determine if hypertonic saline with and without dextran can improve overall survival in victims of trauma with shock.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
1	Experimental	Drug: 7.5% hypertonic saline/6% Dextran-70 (HSD)7.5% hypertonic saline/6% Dextran-70 (HSD)
2	Experimental	Drug: 7.5% hypertonic saline (HS)7.5% hypertonic saline (HS)
3	Placebo comparator	Drug: 0.9% normal saline0.9% normal saline

Who may qualify

Ages: 15 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

Blunt or penetrating trauma
Prehospital Systolic Blood Pressure (SBP) <= 70;OR
Prehospital SBP 71-90 AND Hear Rate (HR) ≥108
15 years of age or older, or 50kg or more if age unknown

Key exclusion criteria (11 listed)

Known or suspected pregnancy
Age younger than 15 or less than 50kg if age unknown
Ongoing prehospital cardiopulmonary resuscitation (CPR)
Administration of more than 2000cc crystalloid or any colloid or blood products
Severe hypothermia (suspected Temperature less than 28 degrees celsius)

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
7.5% hypertonic saline/6% Dextran-70 (HSD)Also: RescueFlo250 cc dose given as a one-time intravenous (IV) bolus in the pre-hospital setting.	Drug	1
7.5% hypertonic saline (HS)250 cc dose given as a one-time IV bolus in the pre-hospital setting.	Drug	2
0.9% normal saline250 cc dose given as a one-time IV bolus in the pre-hospital setting.	Drug	3

Primary outcome

28 Day Survival
Time frame: 28 days from time of Emergency Department (ED) arrival
The day of episode is counted as "Day 0". So for measures using a 28 day period, the maximum value is 29 (i.e. days 0 through 28).

21 secondary outcomes

Adult Respiratory Distress Syndrome(ARDS)-Free Survival Through Day 28
Time frame: 28 days from time of ED arrival
Worst Multiple Organ Dysfunction Score (MODS) Mean Through Day 28
Time frame: 28 days from time of ED arrival
Presence of Nosocomial Infection Through Day 28
Time frame: Within 28 days of injury, while hospitalized
Packed Red Blood Cells (PRBC) First 24 Hours
Time frame: First 24 hours from the time of 911 call
Total Fluids First 24 Hours
Time frame: First 24 hours from the time of of 911 call
Ventilator-free Days Through Day 28
Time frame: Duration of hospital stay through day 28
Days Alive Out of the Intensive Care Unit (ICU) Through Day 28
Time frame: First 28 days from the time of 911 call
Days Alive Out of the Hospital Through Day 28
Time frame: First 28 days from the time of 911 call
Survival at Hospital Discharge
Time frame: Duration of hospital stay through to discharge
Zero Units PRBC in First 24 Hours
Time frame: From the time dispatch received the 911 call to the end of the first 24 hours
Zero Units PRBC and Died in Field or Emergency Department (ED)
Time frame: From the time dispatch received 911 call to the time of death in the field or ED
Zero Units PRBC and Died Within 6 Hours of Admission to the Hospital
Time frame: The first 6 hours from the time of admission to the hospital
Zero Units PRBC and Died Within 28 Days From the Time of the 911 Call
Time frame: From the time dispatch received the 911 call to 28 days
1-9 Units PRBC in First 24 Hours
Time frame: From the time dispatch received the 911 call to the end of the first 24 hours
1-9 Units PRBC and Died in Field or ED
Time frame: From the time dispatch received 911 call to the time of death in the field or ED
1-9 Units PRBC and Died Within 6 Hours of Admission to the Hospital
Time frame: The first 6 hours from the time of admission to the hospital
1-9 Units PRBC and Died Within 28 Days From the Time of the 911 Call
Time frame: From the time dispatch received the 911 call to 28 days
Greater Than 10 Units PRBC in First 24 Hours
Time frame: From the time dispatch received the 911 call to the end of the first 24 hours
Greater Than 10 Units PRBC and Died in Field or ED
Time frame: From the time dispatch received 911 call to the time of death in the field or ED
Greater Than 10 Units PRBC and Died Within 6 Hours of Admission to the Hospital
Time frame: The first 6 hours from the time of admission to the hospital
Greater Than 10 Units PRBC and Died Within 28 Days From the Time of the 911 Call
Time frame: From the time dispatch received the 911 call to 28 days

Results and safety

Results posted to the registry on 11 Nov 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
7.5% Hypertonic Saline/6% Dextran-70 (HSD)	231	220
7.5% Hypertonic Saline (HS)	269	256
0.9% Normal Saline	395	376

Primary outcome: 28 Day Survival

Time frame: 28 days from time of Emergency Department (ED) arrival. Number. Unit: participants

Measure	7.5% Hypertonic Saline/6% Dextran-70 (HSD) n = 220	7.5% Hypertonic Saline (HS) n = 256	0.9% Normal Saline n = 376
Value	164	187	279

7.5% Hypertonic Saline/6% Dextran-70 (HSD) vs 7.5% Hypertonic Saline (HS) vs 0.9% Normal Saline: p = 0.91, test for proportions

Population analysed: Per protocol, analysis was done on only those subjects who received the study fluid per randomization; this was defined as that the study fluid had been connected to the patient's IV.

21 secondary outcomes are reported in the full results.

Adverse events

Time frame: Between May 2006 and August 2009, which was 3 years and 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
7.5% Hypertonic Saline/6% Dextran-70 (HSD)	21 of 220 (9.5%)	1 of 220 (0.5%)	Not reported
7.5% Hypertonic Saline (HS)	25 of 256 (9.8%)	1 of 256 (0.4%)	Not reported
0.9% Normal Saline	21 of 376 (5.6%)	1 of 376 (0.3%)	Not reported

Limitations and caveats (from the sponsor): The trial was stopped early for futility in the presence of a potential safety concern regarding increased mortality among patients receiving hypertonic solutions and no blood transfusions. This was no longer evident 6 hr after hospital admission.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21178763Bulger EM, May S, Kerby JD, Emerson S, Stiell IG, Schreiber MA, Brasel KJ, Tisherman SA, Coimbra R, Rizoli S, Minei JP, Hata JS, Sopko G, Evans DC, Hoyt DB; ROC investigators. Out-of-hospital hypertonic resuscitation after traumatic hypovolemic shock: a randomized, placebo controlled trial. Ann Surg. 2011 Mar;253(3):431-41. doi: 10.1097/SLA.0b013e3181fcdb22.
Derived from this study: PubMed 25072443Tisherman SA, Schmicker RH, Brasel KJ, Bulger EM, Kerby JD, Minei JP, Powell JL, Reiff DA, Rizoli SB, Schreiber MA. Detailed description of all deaths in both the shock and traumatic brain injury hypertonic saline trials of the Resuscitation Outcomes Consortium. Ann Surg. 2015 Mar;261(3):586-90. doi: 10.1097/SLA.0000000000000837.

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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.

Myron L Weisfeldt, MD study chair

Resuscitation Outcomes Consortium

10 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 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: stopped early, as of the sponsor's last update on 1 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States, Canada. 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 phase mean?

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?

Yes. Results are posted in the registry (first posted 11 Nov 2010). 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?

28 Day Survival (time frame: 28 days from time of Emergency Department (ED) arrival). 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 NCT00316017, 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 1 Mar 2011.