Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01262196




Registration number
NCT01262196
Ethics application status
Date submitted
15/12/2010
Date registered
17/12/2010
Date last updated
22/08/2013

Titles & IDs
Public title
Phase IIb Study of MP4OX in Traumatic Hemorrhagic Shock Patients
Scientific title
A Multi-center, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of MP4OX Treatment, in Addition to Standard Treatment, in Severely Injured Trauma Patients With Lactic Acidosis Due to Hemorrhagic Shock
Secondary ID [1] 0 0
TRA-205
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shock, Hemorrhagic 0 0
Shock, Traumatic 0 0
Acidosis, Lactic 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Renal and Urogenital 0 0 0 0
Kidney disease
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Blood 0 0 0 0
Other blood disorders
Injuries and Accidents 0 0 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - MP4OX
Treatment: Drugs - Saline

Experimental: MP4OX - 250-mL dose

Placebo comparator: Control - 250-mL of normal saline solution


Treatment: Drugs: MP4OX
4.3 g/dL pegylated hemoglobin in balanced lactate-electrolyte solution

Treatment: Drugs: Saline
Normal saline (0.9%) solution
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of patients discharged from hospital through day 28 and alive at the Day 28 follow-up visit
Timepoint [1] 0 0
28 days
Secondary outcome [1] 0 0
Hospital-free, ICU-free, and ventilator-free days
Timepoint [1] 0 0
Through 28 days
Secondary outcome [2] 0 0
Composite endpoint of Time to Complete Organ Failure Resolution (CTCOFR)
Timepoint [2] 0 0
At 14 and 21 days
Secondary outcome [3] 0 0
Proportion of patients who normalize (= 2.2 mmol/L) lactate levels
Timepoint [3] 0 0
2, 4, 6, 8 and 12 hours
Secondary outcome [4] 0 0
Proportion of patients remaining: (1) in hospital, (2) in ICU, and (3) on ventilator through Day 28
Timepoint [4] 0 0
28 days
Secondary outcome [5] 0 0
Number of days: (1) in hospital, (2) in ICU, and (3) on the ventilator
Timepoint [5] 0 0
Through 28 days
Secondary outcome [6] 0 0
All-cause mortality
Timepoint [6] 0 0
At 48 hours and at 28 days
Secondary outcome [7] 0 0
Time (days) from randomization to: (1) death, (2) discharge from hospital, (3) discharge from ICU, and (4) liberation from mechanical ventilation
Timepoint [7] 0 0
Through 28 days
Secondary outcome [8] 0 0
Sequential organ failure assessment (SOFA score)
Timepoint [8] 0 0
Daily
Secondary outcome [9] 0 0
Modified Denver score
Timepoint [9] 0 0
Daily

Eligibility
Key inclusion criteria
* Adult male or female (surgically sterile or post-menopausal or confirmed not to be pregnant)
* Trauma injury (blunt and/or penetrating) resulting in lactic acidosis due to hemorrhagic shock
* Acidosis (blood lactate level = 5 mmol/L; equivalent to 45 mg/dL) arterial or venous
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Massive injury incompatible with life
* Normalization of lactate prior to dosing (= 2.2 mmol/L)
* Patients with evidence of severe traumatic brain injury as defined by ANY one of the following: Known non-survivable head injury or open brain injury; Glasgow Coma Score (GCS) = 3, 4 or 5; Known AIS (head region) = 4 shown by an appropriate imaging methodology; Contemplated CNS surgery; or Abnormal physical exam indicative of severe CNS or any spinal cord injury above T5 level
* Cardiac arrest prior to randomization
* Age below the legal age for consenting
* Estimated time from injury to randomization> 4 hours
* Estimated time from hospital admission to randomization > 2 hours
* Known pregnancy
* Use of any oxygen carrier other than RBCs
* Known previous participation in this study
* Professional or ancillary personnel involved with this study
* Known receipt of any investigational drug(s) within 30 days prior to study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2012
Sample size
Target
Accrual to date
Final
348
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Liverpoool Hospital NSW - Liverpool
Recruitment hospital [2] 0 0
John Hunter Hospital - Newcastle
Recruitment postcode(s) [1] 0 0
- Liverpool
Recruitment postcode(s) [2] 0 0
- Newcastle
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Gratz
Country [2] 0 0
Brazil
State/province [2] 0 0
Sao Paolo
Country [3] 0 0
Brazil
State/province [3] 0 0
São José do Rio Preto
Country [4] 0 0
Colombia
State/province [4] 0 0
Cali
Country [5] 0 0
France
State/province [5] 0 0
Clichy
Country [6] 0 0
France
State/province [6] 0 0
Grenoble
Country [7] 0 0
France
State/province [7] 0 0
Le Kremlin Bicetre
Country [8] 0 0
France
State/province [8] 0 0
Lille
Country [9] 0 0
France
State/province [9] 0 0
Limoges
Country [10] 0 0
France
State/province [10] 0 0
Lyon
Country [11] 0 0
France
State/province [11] 0 0
Paris
Country [12] 0 0
Germany
State/province [12] 0 0
Aachen
Country [13] 0 0
Germany
State/province [13] 0 0
Berlin
Country [14] 0 0
Germany
State/province [14] 0 0
Cologne
Country [15] 0 0
Germany
State/province [15] 0 0
Frankfurt
Country [16] 0 0
Germany
State/province [16] 0 0
Ludwigshafen
Country [17] 0 0
Israel
State/province [17] 0 0
Beersheba
Country [18] 0 0
Israel
State/province [18] 0 0
Haifa
Country [19] 0 0
Israel
State/province [19] 0 0
Jerusalem
Country [20] 0 0
New Zealand
State/province [20] 0 0
Auckland
Country [21] 0 0
Norway
State/province [21] 0 0
Oslo
Country [22] 0 0
Singapore
State/province [22] 0 0
Singapore
Country [23] 0 0
South Africa
State/province [23] 0 0
Alberton
Country [24] 0 0
South Africa
State/province [24] 0 0
Cape Town
Country [25] 0 0
South Africa
State/province [25] 0 0
Centurion
Country [26] 0 0
South Africa
State/province [26] 0 0
Johannesburg
Country [27] 0 0
South Africa
State/province [27] 0 0
Soweto
Country [28] 0 0
Spain
State/province [28] 0 0
Madrid
Country [29] 0 0
Switzerland
State/province [29] 0 0
Lausanne
Country [30] 0 0
Switzerland
State/province [30] 0 0
Zurich
Country [31] 0 0
United Kingdom
State/province [31] 0 0
London
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sangart
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Karim Brohi, MD
Address 0 0
The Royal London Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01262196