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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