Acute Respiratory Distress SyndromeNCT05857891
The Effect of Erythropoietin on Alveolar Fluid Clearance in Patients With Acute Respiratory Distress Syndrome
A study testing Human erythropoietin injection and 0.9%NaCl in people with Acute Respiratory Distress Syndrome, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
Acute respiratory distress syndrome (ARDS) is a common acute and critical disease in clinic. The clinical mortality is as high as 30%-40%. At present, there is no specific treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- Human erythropoietin injection and 0.9%NaCl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2023to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age≥18 years;
- Meeting diagnostic criteria for sepsis 3.0;
- Tracheal intubation and mechanical ventilation;
- Meeting the diagnostic criteria of ARDS Berlin;
- Willing to accept treatment and sign an informed consent form;
Who cannot join
- Age <18 years;
- Pregnancy or lactation;
- Patients with malignant tumors;
- Recombinant human erythropoietin (rhEPO) allergic patients;
- Hemoglobin (Hb) ≥120g/L;
- have recently taken rhEPO (within 3 months) or participated in other clinical trials;
- History of thromboembolic disease (pulmonary embolism, heart attack, cerebral infarction, arteriovenous thrombosis);
- Inability or unwillingness to provide informed consent or to comply with the requirements of the study;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Acute respiratory distress syndrome (ARDS) is a common acute and critical disease in clinic. The clinical mortality is as high as 30%-40%. At present, there is no specific treatment. Erythropoietin (EPO), also known as erythrocyte- stimulating factor, erythropoietin, has a certain amount in normal human body, mainly synthesized by liver in infants and kidneys in adults, which can stimulate erythropoiesis. In recent years, more and more studies have shown that high-dose exogenous EPO administration has benefit effects on multi-organ protection. Therefore, we designed this prospective, double-blind, placebo-controlled trial for defecting EPO on the alveolar fluid clearance of ARDS. The study mainly answers the following questions: Does human erythropoietin accelerate the resolution of alveolar edema in ARDS? Is there any effect on hospital survival? The study will draw conclusions by comparing the control group with the experimental group.
Read the detailed description
This study was designed as a double-blind, randomized controlled trial. Neither the subject nor the investigator knew the allocation of treatment drugs. Subjects signed the informed consent form, completed all screening assessments, and were randomized in the order of screening eligibility after screening eligibility. The investigator or designee generated the corresponding case number and drug number using a simple randomization method. Information about the subject's trial product allocation was placed in an emergency envelope and retained by the investigator for use in an emergency. Randomised subjects who withdraw from the clinical trial for any reason, regardless of whether they have taken the trial medication, will retain their case number and medication number and will not be allowed to re-enter the trial.
The investigator participating in this trial is a clinician with appropriate experience, who can make treatment decision based on the clinical response and laboratory test results of the subject. The specific process of the study is as follows:
- The subjects of this study were patients with ARDS admitted to ICU.
- After signing the informed consent form, complete medical history collection, vital signs and detailed physical examination will be performed. Patients meeting the inclusion criteria but not meeting the exclusion criteria will be randomized into the study.
- Patients with ARDS who met the inclusion criteria were connected to PiCCO, randomly assigned to the following two groups, and monitored continuously for 3 days. Group A: Erythropoietin, 40000 IU, single intravenous injection. Group B: 0.9%NaCl group, with the same volume as group A, single intravenous injection.
- The baseline values of extravascular lung water index (EVLWI) and pulmonary vascular permeability index (PVPI) were monitored by PiCCO after recording the general conditions of the subjects included in the study before intervention. After EPO or 0.9% NaCl intervention, EVLWI and PVPI at 0, 6, 12, 24, 48 and 72h after EPO or normal saline administration, and blood gas analysis, CRP, PCT, blood routine, inflammatory factors (TNF-a,IL-6,IL-8,IL-1β), endothelial cell injury marker (s-ICAM-1), alveolar epithelial cell injury marker (sRAGE,SP-D) and other laboratory indicators and clinical indicators such as peak airway pressure, mean airway pressure and positive end-expiratory pressure (PEEP) at 0, 1, 2 and 3 days after administration were recorded. The hospital survival rate and 28-day survival rate were compared between the experimental group and the control group.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- Human erythropoietin injection, 0.9%NaCl
- Keywords
- Erythropoietin, ARDS, Lung Water Clearance
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human erythropoietin injectionDrug
Also called Treatment measures taken according to the patient's condition
Each subject in the test group received 40000iu of human erythropoietin intravenously
0.9%NaClDrug
Also called Treatment measures taken according to the patient's condition
Each subject in the control group was injected with an equal volume of 0.9%NaCl
| Study group | Role | What they receive |
|---|---|---|
| Erythropoietin group | Experimental | intravenous injection of 40000iu of rhEPO Receives: Drug: Human erythropoietin injection |
| 0.9%NS | Placebo comparator | intravenous injection of the same volume of 0.9%NS as the test group Receives: Drug: 0.9%NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
EVLWI
extravascular lung water index
Measured: Changes of EVLWI at 0,6,12,24 ,48 and 72 hours after intervention
PVPI
pulmonary vascular permeability index
Measured: Changes of PVPI at 0,6,12,24 ,48 and 72 hours after intervention
Secondary outcomes (2)
Survival rate
28-day survival rate
Measured: 28-day hospital survival
Oxygenation index
PaO2/FiO2
Measured: Changes of oxygenation index at 0, 1, 2 and 3 days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start20 May 2023 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ye Gao, PhD, Study director, Second Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05857891
- Sponsor's protocol ID
- SAHoWMU-CR2018-11-134
- Status last verified
- May 2023
- First submitted
- 24 Apr 2023
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291.
PubMed 26903337Wiese L, Hempel C, Penkowa M, Kirkby N, Kurtzhals JA. Recombinant human erythropoietin increases survival and reduces neuronal apoptosis in a murine model of cerebral malaria. Malar J. 2008 Jan 7;7:3. doi: 10.1186/1475-2875-7-3.
PubMed 18179698Gantner DC, Bailey M, Presneill J, French CJ, Nichol A, Little L, Bellomo R; EPO-TBI Investigators; the ANZICS Clinical Trials Group. Erythropoietin to Reduce Mortality in Traumatic Brain Injury: A Post-hoc Dose-effect Analysis. Ann Surg. 2018 Mar;267(3):585-589. doi: 10.1097/SLA.0000000000002142.
PubMed 28151802Tsai TH, Lu CH, Wallace CG, Chang WN, Chen SF, Huang CR, Tsai NW, Lan MY, Sung PH, Liu CF, Yip HK. Erythropoietin improves long-term neurological outcome in acute ischemic stroke patients: a randomized, prospective, placebo-controlled clinical trial. Crit Care. 2015 Feb 25;19(1):49. doi: 10.1186/s13054-015-0761-8.
PubMed 25888250Yip HK, Tsai TH, Lin HS, Chen SF, Sun CK, Leu S, Yuen CM, Tan TY, Lan MY, Liou CW, Lu CH, Chang WN. Effect of erythropoietin on level of circulating endothelial progenitor cells and outcome in patients after acute ischemic stroke. Crit Care. 2011;15(1):R40. doi: 10.1186/cc10002. Epub 2011 Jan 26.
PubMed 21269484Ozawa T, Toba K, Suzuki H, Kato K, Iso Y, Akutsu Y, Kobayashi Y, Takeyama Y, Kobayashi N, Yoshimura N, Akazawa K, Aizawa Y; EPO/AMI-I Pilot Study Researchers. Single-dose intravenous administration of recombinant human erythropoietin is a promising treatment for patients with acute myocardial infarction - randomized controlled pilot trial of EPO/AMI-1 study -. Circ J. 2010 Jul;74(7):1415-23. doi: 10.1253/circj.cj-10-0109. Epub 2010 May 22.
PubMed 20501957Voors AA, Belonje AM, Zijlstra F, Hillege HL, Anker SD, Slart RH, Tio RA, van 't Hof A, Jukema JW, Peels HO, Henriques JP, Ten Berg JM, Vos J, van Gilst WH, van Veldhuisen DJ; HEBE III Investigators. A single dose of erythropoietin in ST-elevation myocardial infarction. Eur Heart J. 2010 Nov;31(21):2593-600. doi: 10.1093/eurheartj/ehq304. Epub 2010 Aug 29.
PubMed 20802250Tsai TH, Lu CH, Wallace CG, Chang WN, Chen SF, Huang CR, Tsai NW, Lan MY, Sung PH, Liu CF, Yip HK. Erratum to: Erythropoietin improves long-term neurological outcome in acute ischemic stroke patients: a randomized, prospective, placebo-controlled clinical trial. Crit Care. 2016 Mar 31;20:78. doi: 10.1186/s13054-016-1256-y. No abstract available.
PubMed 27037155Suhs KW, Hein K, Sattler MB, Gorlitz A, Ciupka C, Scholz K, Kasmann-Kellner B, Papanagiotou P, Schaffler N, Restemeyer C, Bittersohl D, Hassenstein A, Seitz B, Reith W, Fassbender K, Hilgers R, Heesen C, Bahr M, Diem R. A randomized, double-blind, phase 2 study of erythropoietin in optic neuritis. Ann Neurol. 2012 Aug;72(2):199-210. doi: 10.1002/ana.23573.
PubMed 22926853Corwin HL, Gettinger A, Fabian TC, May A, Pearl RG, Heard S, An R, Bowers PJ, Burton P, Klausner MA, Corwin MJ; EPO Critical Care Trials Group. Efficacy and safety of epoetin alfa in critically ill patients. N Engl J Med. 2007 Sep 6;357(10):965-76. doi: 10.1056/NEJMoa071533.
PubMed 17804841Kakavas S, Demestiha T, Vasileiou P, Xanthos T. Erythropoetin as a novel agent with pleiotropic effects against acute lung injury. Eur J Clin Pharmacol. 2011 Jan;67(1):1-9. doi: 10.1007/s00228-010-0938-7. Epub 2010 Nov 11.
PubMed 21069520Rocha J, Eduardo-Figueira M, Barateiro A, Fernandes A, Brites D, Pinto R, Freitas M, Fernandes E, Mota-Filipe H, Sepodes B. Erythropoietin reduces acute lung injury and multiple organ failure/dysfunction associated to a scald-burn inflammatory injury in the rat. Inflammation. 2015 Feb;38(1):312-26. doi: 10.1007/s10753-014-0035-7.
PubMed 25270658Tascilar O, Cakmak GK, Tekin IO, Emre AU, Ucan BH, Bahadir B, Acikgoz S, Irkorucu O, Karakaya K, Balbaloglu H, Kertis G, Ankarali H, Comert M. Protective effects of erythropoietin against acute lung injury in a rat model of acute necrotizing pancreatitis. World J Gastroenterol. 2007 Dec 14;13(46):6172-82. doi: 10.3748/wjg.v13.i46.6172.
PubMed 18069756MacRedmond R, Singhera GK, Dorscheid DR. Erythropoietin inhibits respiratory epithelial cell apoptosis in a model of acute lung injury. Eur Respir J. 2009 Jun;33(6):1403-14. doi: 10.1183/09031936.00084608. Epub 2009 Jan 22.
PubMed 19164355Heeschen C, Aicher A, Lehmann R, Fichtlscherer S, Vasa M, Urbich C, Mildner-Rihm C, Martin H, Zeiher AM, Dimmeler S. Erythropoietin is a potent physiologic stimulus for endothelial progenitor cell mobilization. Blood. 2003 Aug 15;102(4):1340-6. doi: 10.1182/blood-2003-01-0223. Epub 2003 Apr 17.
PubMed 12702503
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Erythropoietin on Alveolar Fluid Clearance in Patients With Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT05857891
- Acronym / sponsor ID
- SAHoWMU-CR2018-11-134
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- Erythropoietin, ARDS, Lung Water Clearance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 20 May 2023 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 15 May 2023 (actual)
- 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.
Acute respiratory distress syndrome (ARDS) is a common acute and critical disease in clinic. The clinical mortality is as high as 30%-40%. At present, there is no specific treatment. Erythropoietin (EPO), also known as erythrocyte- stimulating factor, erythropoietin, has a certain amount in normal human body, mainly synthesized by liver in infants and kidneys in adults, which can stimulate erythropoiesis. In recent years, more and more studies have shown that high-dose exogenous EPO administration has benefit effects on multi-organ protection. Therefore, we designed this prospective, double-blind, placebo-controlled trial for defecting EPO on the alveolar fluid clearance of ARDS. The study mainly answers the following questions: Does human erythropoietin accelerate the resolution of alveolar edema in ARDS? Is there any effect on hospital survival? The study will draw conclusions by comparing the control group with the experimental group.
Detailed description
This study was designed as a double-blind, randomized controlled trial. Neither the subject nor the investigator knew the allocation of treatment drugs. Subjects signed the informed consent form, completed all screening assessments, and were randomized in the order of screening eligibility after screening eligibility. The investigator or designee generated the corresponding case number and drug number using a simple randomization method. Information about the subject's trial product allocation was placed in an emergency envelope and retained by the investigator for use in an emergency. Randomised subjects who withdraw from the clinical trial for any reason, regardless of whether they have taken the trial medication, will retain their case number and medication number and will not be allowed to re-enter the trial.
The investigator participating in this trial is a clinician with appropriate experience, who can make treatment decision based on the clinical response and laboratory test results of the subject. The specific process of the study is as follows:
- The subjects of this study were patients with ARDS admitted to ICU.
- After signing the informed consent form, complete medical history collection, vital signs and detailed physical examination will be performed. Patients meeting the inclusion criteria but not meeting the exclusion criteria will be randomized into the study.
- Patients with ARDS who met the inclusion criteria were connected to PiCCO, randomly assigned to the following two groups, and monitored continuously for 3 days. Group A: Erythropoietin, 40000 IU, single intravenous injection. Group B: 0.9%NaCl group, with the same volume as group A, single intravenous injection.
- The baseline values of extravascular lung water index (EVLWI) and pulmonary vascular permeability index (PVPI) were monitored by PiCCO after recording the general conditions of the subjects included in the study before intervention. After EPO or 0.9% NaCl intervention, EVLWI and PVPI at 0, 6, 12, 24, 48 and 72h after EPO or normal saline administration, and blood gas analysis, CRP, PCT, blood routine, inflammatory factors (TNF-a,IL-6,IL-8,IL-1β), endothelial cell injury marker (s-ICAM-1), alveolar epithelial cell injury marker (sRAGE,SP-D) and other laboratory indicators and clinical indicators such as peak airway pressure, mean airway pressure and positive end-expiratory pressure (PEEP) at 0, 1, 2 and 3 days after administration were recorded. The hospital survival rate and 28-day survival rate were compared between the experimental group and the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erythropoietin group | Experimental | Drug: Human erythropoietin injectionintravenous injection of 40000iu of rhEPO |
| 0.9%NS | Placebo comparator | Drug: 0.9%NaClintravenous injection of the same volume of 0.9%NS as the test group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age≥18 years;
- Meeting diagnostic criteria for sepsis 3.0;
- Tracheal intubation and mechanical ventilation;
- Meeting the diagnostic criteria of ARDS Berlin;
- Willing to accept treatment and sign an informed consent form;
Key exclusion criteria (8 listed)
- Age <18 years;
- Pregnancy or lactation;
- Patients with malignant tumors;
- Recombinant human erythropoietin (rhEPO) allergic patients;
- Hemoglobin (Hb) ≥120g/L;
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 |
|---|---|---|
| Human erythropoietin injectionAlso: Treatment measures taken according to the patient's conditionEach subject in the test group received 40000iu of human erythropoietin intravenously | Drug | Erythropoietin group |
| 0.9%NaClAlso: Treatment measures taken according to the patient's conditionEach subject in the control group was injected with an equal volume of 0.9%NaCl | Drug | 0.9%NS |
Primary outcome
EVLWI
Time frame: Changes of EVLWI at 0,6,12,24 ,48 and 72 hours after intervention
extravascular lung water index
PVPI
Time frame: Changes of PVPI at 0,6,12,24 ,48 and 72 hours after intervention
pulmonary vascular permeability index
2 secondary outcomes
Survival rate
Time frame: 28-day hospital survival
Oxygenation index
Time frame: Changes of oxygenation index at 0, 1, 2 and 3 days after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
- Results publication: PubMed 26903337Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291.
- Results publication: PubMed 18179698Wiese L, Hempel C, Penkowa M, Kirkby N, Kurtzhals JA. Recombinant human erythropoietin increases survival and reduces neuronal apoptosis in a murine model of cerebral malaria. Malar J. 2008 Jan 7;7:3. doi: 10.1186/1475-2875-7-3.
- Results publication: PubMed 28151802Gantner DC, Bailey M, Presneill J, French CJ, Nichol A, Little L, Bellomo R; EPO-TBI Investigators; the ANZICS Clinical Trials Group. Erythropoietin to Reduce Mortality in Traumatic Brain Injury: A Post-hoc Dose-effect Analysis. Ann Surg. 2018 Mar;267(3):585-589. doi: 10.1097/SLA.0000000000002142.
- Results publication: PubMed 25888250Tsai TH, Lu CH, Wallace CG, Chang WN, Chen SF, Huang CR, Tsai NW, Lan MY, Sung PH, Liu CF, Yip HK. Erythropoietin improves long-term neurological outcome in acute ischemic stroke patients: a randomized, prospective, placebo-controlled clinical trial. Crit Care. 2015 Feb 25;19(1):49. doi: 10.1186/s13054-015-0761-8.
- Results publication: PubMed 21269484Yip HK, Tsai TH, Lin HS, Chen SF, Sun CK, Leu S, Yuen CM, Tan TY, Lan MY, Liou CW, Lu CH, Chang WN. Effect of erythropoietin on level of circulating endothelial progenitor cells and outcome in patients after acute ischemic stroke. Crit Care. 2011;15(1):R40. doi: 10.1186/cc10002. Epub 2011 Jan 26.
- Results publication: PubMed 20501957Ozawa T, Toba K, Suzuki H, Kato K, Iso Y, Akutsu Y, Kobayashi Y, Takeyama Y, Kobayashi N, Yoshimura N, Akazawa K, Aizawa Y; EPO/AMI-I Pilot Study Researchers. Single-dose intravenous administration of recombinant human erythropoietin is a promising treatment for patients with acute myocardial infarction - randomized controlled pilot trial of EPO/AMI-1 study -. Circ J. 2010 Jul;74(7):1415-23. doi: 10.1253/circj.cj-10-0109. Epub 2010 May 22.
- Results publication: PubMed 20802250Voors AA, Belonje AM, Zijlstra F, Hillege HL, Anker SD, Slart RH, Tio RA, van 't Hof A, Jukema JW, Peels HO, Henriques JP, Ten Berg JM, Vos J, van Gilst WH, van Veldhuisen DJ; HEBE III Investigators. A single dose of erythropoietin in ST-elevation myocardial infarction. Eur Heart J. 2010 Nov;31(21):2593-600. doi: 10.1093/eurheartj/ehq304. Epub 2010 Aug 29.
- Results publication: PubMed 27037155Tsai TH, Lu CH, Wallace CG, Chang WN, Chen SF, Huang CR, Tsai NW, Lan MY, Sung PH, Liu CF, Yip HK. Erratum to: Erythropoietin improves long-term neurological outcome in acute ischemic stroke patients: a randomized, prospective, placebo-controlled clinical trial. Crit Care. 2016 Mar 31;20:78. doi: 10.1186/s13054-016-1256-y. No abstract available.
- Results publication: PubMed 22926853Suhs KW, Hein K, Sattler MB, Gorlitz A, Ciupka C, Scholz K, Kasmann-Kellner B, Papanagiotou P, Schaffler N, Restemeyer C, Bittersohl D, Hassenstein A, Seitz B, Reith W, Fassbender K, Hilgers R, Heesen C, Bahr M, Diem R. A randomized, double-blind, phase 2 study of erythropoietin in optic neuritis. Ann Neurol. 2012 Aug;72(2):199-210. doi: 10.1002/ana.23573.
- Results publication: PubMed 17804841Corwin HL, Gettinger A, Fabian TC, May A, Pearl RG, Heard S, An R, Bowers PJ, Burton P, Klausner MA, Corwin MJ; EPO Critical Care Trials Group. Efficacy and safety of epoetin alfa in critically ill patients. N Engl J Med. 2007 Sep 6;357(10):965-76. doi: 10.1056/NEJMoa071533.
- Results publication: PubMed 21069520Kakavas S, Demestiha T, Vasileiou P, Xanthos T. Erythropoetin as a novel agent with pleiotropic effects against acute lung injury. Eur J Clin Pharmacol. 2011 Jan;67(1):1-9. doi: 10.1007/s00228-010-0938-7. Epub 2010 Nov 11.
- Results publication: PubMed 25270658Rocha J, Eduardo-Figueira M, Barateiro A, Fernandes A, Brites D, Pinto R, Freitas M, Fernandes E, Mota-Filipe H, Sepodes B. Erythropoietin reduces acute lung injury and multiple organ failure/dysfunction associated to a scald-burn inflammatory injury in the rat. Inflammation. 2015 Feb;38(1):312-26. doi: 10.1007/s10753-014-0035-7.
- Individual participant dataSharing planned: No
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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.
Ye Gao, PhD study director
Second Affiliated Hospital of Wenzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Human erythropoietin injection and 0.9%NaCl in people with Acute Respiratory Distress Syndrome, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 15 May 2023. 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 China. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shengwei Jin, Professor (13616663961, jinshengwei69@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EVLWI (time frame: Changes of EVLWI at 0,6,12,24 ,48 and 72 hours after intervention). The study lists 2 primary outcomes in all. 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 NCT05857891, which also lists 18 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 15 May 2023.