TraumaPhase 2NCT01973504
Phase 2c Dose Comparison Study of MP4OX in Trauma
A Phase 2 study testing MP4OX in people with Trauma and Hemorrhagic Shock, run by Sangart at 31 sites in 11 countries.
Trial summary
MP4OX is being developed as an ischemic rescue therapy to perfuse and oxygenate tissues at risk during hemorrhagic shock. MP4OX is a pegylated hemoglobin-based colloid designed to improve perfusion and target delivery of oxygen to ischemic tissues. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma, Hemorrhagic Shock, Lactic Acidosis
- What is being tested?
- MP4OX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 31 sitesin 11 countries
- Study dates
- Dec 2013to Mar 2016
- Phase
- Phase 2
- 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
- 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)
Who cannot join
- Massive injury incompatible with life
- Normalization of lactate prior to dosing (≤ 2.2 mmol/L)
- Evidence of severe traumatic brain injury (TBI) as defined by ANY one of the following: Known non-survivable head injury or open brain injury; Known AIS (head region) ≥ 4 by an appropriate imaging methodology; Contemplated CNS surgery; Abnormal physical exam indicative of severe CNS or any spinal cord injury above T5 level; or Glasgow Coma Score (GCS) = 3, 4 or 5.
- Cardiac arrest prior to randomization
- Known age below the legal age for consenting
- Estimated time from injury to randomization > 4 hours
Show all 12Show fewer
- 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
Trial locations and contacts
31 sites in 11 countries.
31 sites in 11 countries
France6 sites
Hôpital Beaujon
Clichy
Hôpital du Kremlin Bicêtre
Le Kremlin-Bicêtre
Hôpital Roger Salengro, CHRU Lille
Lille
CHU Dupuytren
Limoges
Hôpital Edouard Herriot
Lyon
Hôpital Pitié-Salpêtrière
Paris
Germany5 sites
Universitätsklinikum der Rheinisch-Westfälische Technische Hochschule Aachen
Aachen
Campus Virchow Klinikum Charité Berlin
Berlin
Kliniken der Stadt Köln gGmbH Krankenhaus Merheim
Cologne
Klinikum der J.-W.-Goethe-Universität Frankfurt a.M.
Franfurt
BG Klinik Ludwigshafen
Ludwigshafen
South Africa5 sites
Netcare Union Hospital
Alberton
Vincent Palotti Dr Christiaan Barnard Memorial Hospital
Cape Town
Charlotte Maxeke Johannesburg Academic Hospita
Johannesburg
Netcare Milpark Hospital
Johannesburg
Chris Hani Baragwanath Hospital
Soweto
Brazil3 sites
Faculdade de Medicina de S. J. Do Rio Preto
São José do Rio Preto
Hopital Universitário, Centro de Estudos em Emergências em Saúde, USP Ribeirão Preto
São Paulo
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo - FMUSP
São Paulo
Israel3 sites
Soroka University Medical Center
Beersheba
Rambam Health Care Campus
Haifa
Hadassah Medical Organization, Hadassah University Hospital, Ein-Karem
Jerusalem
Belgium2 sites
Erasme University Hospital
Brussels
University Hospital Antwerpen
Edegem
About this study
Official title: A Multi-center, Multinational, Randomized, Double-blind, Controlled, Dose Comparison Study to Evaluate Safety and Efficacy of MP4OX Plus Standard Treatment, in Severely Injured Trauma Subjects With Lactic Acidosis Due to Hemorrhagic Shock
MP4OX is being developed as an ischemic rescue therapy to perfuse and oxygenate tissues at risk during hemorrhagic shock. MP4OX is a pegylated hemoglobin-based colloid designed to improve perfusion and target delivery of oxygen to ischemic tissues. This study will evaluate safety and efficacy of MP4OX treatment, in addition to standard therapy, in trauma patients suffering from lactic acidosis due to severe hemorrhagic shock.
Read the detailed description
Acute trauma, including both blunt and penetrating injury, is often associated with uncontrolled bleeding that leads to hemorrhagic shock. During shock, inadequate blood flow results in local ischemia and tissue hypoxia (insufficient oxygenation) of critical organs with resulting lactic acidosis. More than 10% of trauma victims who reach hospital alive will die, and many will suffer from organ failure. The primary goal when treating traumatic hemorrhage is to control blood loss, support ventilation and oxygenation, and maintain cardiovascular function to maintain organ perfusion.
Despite optimal care, organ dysfunction is present in many patients as evidenced by persistent lactic acidosis. Blood transfusions are intended to improve circulation of oxygen-carrying red blood cells, but are frequently insufficient, even when the hemoglobin level is optimized. The severity of lactic acidosis in trauma victims has also been shown to correlate with worse outcome.
Support for the proposed application for MP4OX as a therapeutic adjunct to standard treatment of severe hemorrhage shock, is based on multiple preclinical studies in different animal models of hemorrhagic shock resuscitation. These preclinical studies demonstrated that survival was greater and restoration of acid-base status and hemodynamics were improved with MP4OX. The benefits of MP4OX in animals were observed with or without co-administration of autologous blood, demonstrating that red cell transfusion alone was insufficient, and that the effects of MP4OX were additive.
The hypothesis for the current study is that MP4OX will enhance perfusion and oxygenation of ischemic organs and thereby prevent and reduce the duration of organ failure and improve morbidity and mortality outcome measures.
- Conditions
- Trauma, Hemorrhagic Shock, Lactic Acidosis
- Being tested
- MP4OX, Control
- Keywords
- Trauma, Hemorrhagic shock, Hemorrhage, Lactic acidosis, Oxygen therapeutics, Oxygen carriers, Ischemic rescue therapy, Hemoglobin solutions, PEGylated hemoglobin
- Medical subject headings
- Wounds and Injuries, Shock, Hemorrhagic, Acidosis, Lactic, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MP4OXDrug
Also called Hemoglobin pegylated, MalPEG-Hb, MP4, PEG-Hb
4.3 g/dL pegylated hemoglobin in balanced lactate-electrolyte solution
ControlDrug
Also called Keep vein open (KVO) infusion, Sham infusion
Crystalloid solution IV infusion drip to keep vein open
| Study group | Role | What they receive |
|---|---|---|
| MP4OX 500-mL | Experimental | 500-mL dose of MP4OX Receives: Drug: MP4OX |
| MP4OX 750-mL | Experimental | 750-mL dose of MP4OX Receives: Drug: MP4OX |
| Control | Sham comparator | Standard crystalloid Keep Vein Open (KVO) infusion Receives: Drug: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects discharged from hospital through Day 28 and alive at the Day 28 Follow up visit
Measured: 28 days
Secondary outcomes (6)
Hospital-free, ICU-free, and Ventilator-free days
Measured: Through 28 and 60 days
Proportion of subjects remaining in hospital, ICU or on ventilator
Measured: Through 28 and 60 days
Days in hospital, in ICU, or on Ventilator
Measured: Through 28 and 60 days
All-cause Mortality
Measured: At 48 hours and 28 or 60 days
Time to discharge from ICU, hospital discharge, or liberation from ventilation
Measured: Through 28 or 60 days
Composite of Time to Complete Organ Failure Resolution (CTCOFR)
Measured: Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2015 (estimated)
- Study completionMar 2016 (estimated)
Why it stopped: Sangart ceased operations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for TraumaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sangart
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karim Brohi, MD, Principal investigator, The Royal London HospitalFrank V. Booth, BCh, FACS, Study chair, Sangart, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01973504
- Sponsor's protocol ID
- TRA-207
- Status last verified
- Oct 2013
- First submitted
- 20 Aug 2013
- Last updated
- 31 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cole RH, Vandegriff KD. MP4, a vasodilatory PEGylated hemoglobin. Adv Exp Med Biol. 2011;701:85-90. doi: 10.1007/978-1-4419-7756-4_12.
PubMed 21445773Young MA, Lohman J, Malavalli A, Vandegriff KD, Winslow RM. Hemospan improves outcome in a model of perioperative hemodilution and blood loss in the rat: comparison with hydroxyethyl starch. J Cardiothorac Vasc Anesth. 2009 Jun;23(3):339-47. doi: 10.1053/j.jvca.2008.08.006. Epub 2008 Oct 22.
PubMed 18948027Vandegriff KD, Winslow RM. Hemospan: design principles for a new class of oxygen therapeutic. Artif Organs. 2009 Feb;33(2):133-8. doi: 10.1111/j.1525-1594.2008.00697.x.
PubMed 19178457Vandegriff KD, Malavalli A, Mkrtchyan GM, Spann SN, Baker DA, Winslow RM. Sites of modification of hemospan, a poly(ethylene glycol)-modified human hemoglobin for use as an oxygen therapeutic. Bioconjug Chem. 2008 Nov 19;19(11):2163-70. doi: 10.1021/bc8002666.
PubMed 18837531Svergun DI, Ekstrom F, Vandegriff KD, Malavalli A, Baker DA, Nilsson C, Winslow RM. Solution structure of poly(ethylene) glycol-conjugated hemoglobin revealed by small-angle X-ray scattering: implications for a new oxygen therapeutic. Biophys J. 2008 Jan 1;94(1):173-81. doi: 10.1529/biophysj.107.114314. Epub 2007 Sep 7.
PubMed 17827244Cole RH, Vandegriff KD, Szeri AJ, Savas O, Baker DA, Winslow RM. A quantitative framework for the design of acellular hemoglobins as blood substitutes: implications of dynamic flow conditions. Biophys Chem. 2007 Jun;128(1):63-74. doi: 10.1016/j.bpc.2007.03.004. Epub 2007 Mar 13.
PubMed 17418478Young MA, Riddez L, Kjellstrom BT, Bursell J, Winslow F, Lohman J, Winslow RM. MalPEG-hemoglobin (MP4) improves hemodynamics, acid-base status, and survival after uncontrolled hemorrhage in anesthetized swine. Crit Care Med. 2005 Aug;33(8):1794-804. doi: 10.1097/01.ccm.0000172648.55309.13.
PubMed 16096458Drobin D, Kjellstrom BT, Malm E, Malavalli A, Lohman J, Vandegriff KD, Young MA, Winslow RM. Hemodynamic response and oxygen transport in pigs resuscitated with maleimide-polyethylene glycol-modified hemoglobin (MP4). J Appl Physiol (1985). 2004 May;96(5):1843-53. doi: 10.1152/japplphysiol.00530.2003. Epub 2004 Jan 16.
PubMed 14729723Winslow RM, Lohman J, Malavalli A, Vandegriff KD. Comparison of PEG-modified albumin and hemoglobin in extreme hemodilution in the rat. J Appl Physiol (1985). 2004 Oct;97(4):1527-34. doi: 10.1152/japplphysiol.00404.2004. Epub 2004 Jun 18.
PubMed 15208289Vandegriff KD, Bellelli A, Samaja M, Malavalli A, Brunori M, Winslow RM. Kinetics of NO and O2 binding to a maleimide poly(ethylene glycol)-conjugated human haemoglobin. Biochem J. 2004 Aug 15;382(Pt 1):183-9. doi: 10.1042/BJ20040156.
PubMed 15175010Tsai AG, Vandegriff KD, Intaglietta M, Winslow RM. Targeted O2 delivery by low-P50 hemoglobin: a new basis for O2 therapeutics. Am J Physiol Heart Circ Physiol. 2003 Oct;285(4):H1411-9. doi: 10.1152/ajpheart.00307.2003. Epub 2003 Jun 12.
PubMed 12805024Vandegriff KD, Malavalli A, Wooldridge J, Lohman J, Winslow RM. MP4, a new nonvasoactive PEG-Hb conjugate. Transfusion. 2003 Apr;43(4):509-16. doi: 10.1046/j.1537-2995.2003.00341.x.
PubMed 12662285McCarthy MR, Vandegriff KD, Winslow RM. The role of facilitated diffusion in oxygen transport by cell-free hemoglobins: implications for the design of hemoglobin-based oxygen carriers. Biophys Chem. 2001 Aug 30;92(1-2):103-17. doi: 10.1016/s0301-4622(01)00194-6.
PubMed 11527583Young MA, Riddez L, Kjellstrom BT, Winslow RM. Effect of maleimide-polyethylene glycol hemoglobin (MP4) on hemodynamics and acid-base status after uncontrolled hemorrhage in anesthetized swine: comparison with crystalloid and blood. J Trauma. 2007 Dec;63(6):1234-44. doi: 10.1097/TA.0b013e31815bd7b0.
PubMed 18212644Wettstein R, Tsai AG, Erni D, Winslow RM, Intaglietta M. Resuscitation with polyethylene glycol-modified human hemoglobin improves microcirculatory blood flow and tissue oxygenation after hemorrhagic shock in awake hamsters. Crit Care Med. 2003 Jun;31(6):1824-30. doi: 10.1097/01.CCM.0000069340.16319.F2.
PubMed 12794426
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Multinational, Randomized, Double-blind, Controlled, Dose Comparison Study to Evaluate Safety and Efficacy of MP4OX Plus Standard Treatment, in Severely Injured Trauma Subjects With Lactic Acidosis Due to Hemorrhagic Shock
- ClinicalTrials.gov ID
- NCT01973504
- Acronym / sponsor ID
- TRA-207
- Conditions
- Trauma, Hemorrhagic Shock, Lactic Acidosis
- Keywords
- Trauma, Hemorrhagic shock, Hemorrhage, Lactic acidosis, Oxygen therapeutics, Oxygen carriers, Ischemic rescue therapy, Hemoglobin solutions
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sangart ceased operations
- Enrolment
- 0 participants (actual)
- Lead sponsor
- SangartIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 31 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
MP4OX is being developed as an ischemic rescue therapy to perfuse and oxygenate tissues at risk during hemorrhagic shock. MP4OX is a pegylated hemoglobin-based colloid designed to improve perfusion and target delivery of oxygen to ischemic tissues. This study will evaluate safety and efficacy of MP4OX treatment, in addition to standard therapy, in trauma patients suffering from lactic acidosis due to severe hemorrhagic shock.
Detailed description
Acute trauma, including both blunt and penetrating injury, is often associated with uncontrolled bleeding that leads to hemorrhagic shock. During shock, inadequate blood flow results in local ischemia and tissue hypoxia (insufficient oxygenation) of critical organs with resulting lactic acidosis. More than 10% of trauma victims who reach hospital alive will die, and many will suffer from organ failure. The primary goal when treating traumatic hemorrhage is to control blood loss, support ventilation and oxygenation, and maintain cardiovascular function to maintain organ perfusion.
Despite optimal care, organ dysfunction is present in many patients as evidenced by persistent lactic acidosis. Blood transfusions are intended to improve circulation of oxygen-carrying red blood cells, but are frequently insufficient, even when the hemoglobin level is optimized. The severity of lactic acidosis in trauma victims has also been shown to correlate with worse outcome.
Support for the proposed application for MP4OX as a therapeutic adjunct to standard treatment of severe hemorrhage shock, is based on multiple preclinical studies in different animal models of hemorrhagic shock resuscitation. These preclinical studies demonstrated that survival was greater and restoration of acid-base status and hemodynamics were improved with MP4OX. The benefits of MP4OX in animals were observed with or without co-administration of autologous blood, demonstrating that red cell transfusion alone was insufficient, and that the effects of MP4OX were additive.
The hypothesis for the current study is that MP4OX will enhance perfusion and oxygenation of ischemic organs and thereby prevent and reduce the duration of organ failure and improve morbidity and mortality outcome measures.
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 |
|---|---|---|
| MP4OX 500-mL | Experimental | Drug: MP4OX500-mL dose of MP4OX |
| MP4OX 750-mL | Experimental | Drug: MP4OX750-mL dose of MP4OX |
| Control | Sham comparator | Drug: ControlStandard crystalloid Keep Vein Open (KVO) infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (12 listed)
- Massive injury incompatible with life
- Normalization of lactate prior to dosing (≤ 2.2 mmol/L)
- Evidence of severe traumatic brain injury (TBI) as defined by ANY one of the following: Known non-survivable head injury or open brain injury; Known AIS (head region) ≥ 4 by an appropriate imaging methodology; Contemplated CNS surgery; Abnormal physical exam indicative of severe CNS or any spinal cord injury above T5 level; or Glasgow Coma Score (GCS) = 3, 4 or 5.
- Cardiac arrest prior to randomization
- Known age below the legal age for consenting
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 |
|---|---|---|
| MP4OXAlso: Hemoglobin pegylated, MalPEG-Hb, MP4, PEG-Hb4.3 g/dL pegylated hemoglobin in balanced lactate-electrolyte solution | Drug | MP4OX 500-mL, MP4OX 750-mL |
| ControlAlso: Keep vein open (KVO) infusion, Sham infusionCrystalloid solution IV infusion drip to keep vein open | Drug | Control |
Primary outcome
Proportion of subjects discharged from hospital through Day 28 and alive at the Day 28 Follow up visit
Time frame: 28 days
6 secondary outcomes
Hospital-free, ICU-free, and Ventilator-free days
Time frame: Through 28 and 60 days
Proportion of subjects remaining in hospital, ICU or on ventilator
Time frame: Through 28 and 60 days
Days in hospital, in ICU, or on Ventilator
Time frame: Through 28 and 60 days
All-cause Mortality
Time frame: At 48 hours and 28 or 60 days
Time to discharge from ICU, hospital discharge, or liberation from ventilation
Time frame: Through 28 or 60 days
Composite of Time to Complete Organ Failure Resolution (CTCOFR)
Time frame: Day 21
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2013.
- Background: PubMed 21445773Cole RH, Vandegriff KD. MP4, a vasodilatory PEGylated hemoglobin. Adv Exp Med Biol. 2011;701:85-90. doi: 10.1007/978-1-4419-7756-4_12.
- Background: PubMed 18948027Young MA, Lohman J, Malavalli A, Vandegriff KD, Winslow RM. Hemospan improves outcome in a model of perioperative hemodilution and blood loss in the rat: comparison with hydroxyethyl starch. J Cardiothorac Vasc Anesth. 2009 Jun;23(3):339-47. doi: 10.1053/j.jvca.2008.08.006. Epub 2008 Oct 22.
- Background: PubMed 19178457Vandegriff KD, Winslow RM. Hemospan: design principles for a new class of oxygen therapeutic. Artif Organs. 2009 Feb;33(2):133-8. doi: 10.1111/j.1525-1594.2008.00697.x.
- Background: PubMed 18837531Vandegriff KD, Malavalli A, Mkrtchyan GM, Spann SN, Baker DA, Winslow RM. Sites of modification of hemospan, a poly(ethylene glycol)-modified human hemoglobin for use as an oxygen therapeutic. Bioconjug Chem. 2008 Nov 19;19(11):2163-70. doi: 10.1021/bc8002666.
- Background: PubMed 17827244Svergun DI, Ekstrom F, Vandegriff KD, Malavalli A, Baker DA, Nilsson C, Winslow RM. Solution structure of poly(ethylene) glycol-conjugated hemoglobin revealed by small-angle X-ray scattering: implications for a new oxygen therapeutic. Biophys J. 2008 Jan 1;94(1):173-81. doi: 10.1529/biophysj.107.114314. Epub 2007 Sep 7.
- Background: PubMed 17418478Cole RH, Vandegriff KD, Szeri AJ, Savas O, Baker DA, Winslow RM. A quantitative framework for the design of acellular hemoglobins as blood substitutes: implications of dynamic flow conditions. Biophys Chem. 2007 Jun;128(1):63-74. doi: 10.1016/j.bpc.2007.03.004. Epub 2007 Mar 13.
- Background: PubMed 16096458Young MA, Riddez L, Kjellstrom BT, Bursell J, Winslow F, Lohman J, Winslow RM. MalPEG-hemoglobin (MP4) improves hemodynamics, acid-base status, and survival after uncontrolled hemorrhage in anesthetized swine. Crit Care Med. 2005 Aug;33(8):1794-804. doi: 10.1097/01.ccm.0000172648.55309.13.
- Background: PubMed 14729723Drobin D, Kjellstrom BT, Malm E, Malavalli A, Lohman J, Vandegriff KD, Young MA, Winslow RM. Hemodynamic response and oxygen transport in pigs resuscitated with maleimide-polyethylene glycol-modified hemoglobin (MP4). J Appl Physiol (1985). 2004 May;96(5):1843-53. doi: 10.1152/japplphysiol.00530.2003. Epub 2004 Jan 16.
- Background: PubMed 15208289Winslow RM, Lohman J, Malavalli A, Vandegriff KD. Comparison of PEG-modified albumin and hemoglobin in extreme hemodilution in the rat. J Appl Physiol (1985). 2004 Oct;97(4):1527-34. doi: 10.1152/japplphysiol.00404.2004. Epub 2004 Jun 18.
- Background: PubMed 15175010Vandegriff KD, Bellelli A, Samaja M, Malavalli A, Brunori M, Winslow RM. Kinetics of NO and O2 binding to a maleimide poly(ethylene glycol)-conjugated human haemoglobin. Biochem J. 2004 Aug 15;382(Pt 1):183-9. doi: 10.1042/BJ20040156.
- Background: PubMed 12805024Tsai AG, Vandegriff KD, Intaglietta M, Winslow RM. Targeted O2 delivery by low-P50 hemoglobin: a new basis for O2 therapeutics. Am J Physiol Heart Circ Physiol. 2003 Oct;285(4):H1411-9. doi: 10.1152/ajpheart.00307.2003. Epub 2003 Jun 12.
- Background: PubMed 12662285Vandegriff KD, Malavalli A, Wooldridge J, Lohman J, Winslow RM. MP4, a new nonvasoactive PEG-Hb conjugate. Transfusion. 2003 Apr;43(4):509-16. doi: 10.1046/j.1537-2995.2003.00341.x.
- Sangart Inc. (San Diego, CA) web site \[Study SPONSOR\]Link provided by the sponsor.
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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.
Karim Brohi, MD principal investigator
The Royal London Hospital
Frank V. Booth, BCh, FACS study chair
Sangart, Inc.
31 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MP4OX in people with Trauma and Hemorrhagic Shock, run by Sangart at 31 sites in 11 countries.
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 2 inclusion and 12 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 31 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in France, Germany, South Africa, Brazil, Israel and 6 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Proportion of subjects discharged from hospital through Day 28 and alive at the Day 28 Follow up visit (time frame: 28 days). 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 NCT01973504, which also lists 20 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 31 Oct 2013.