Moyamoya DiseaseNCT03882060
Effect of Recombinant Human EPO on the Postoperative Neurologic Outcome in Pediatric Moyamoya Patients
A study testing erythropoietin and Normal saline in people with Moyamoya Disease and Pediatrics, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study evaluates the effect of recombinant human erythropoietin (rHuEPO) on the neovascularization of pediatric moyamoya disease patients. rHuEPO will be administrated during perioperative period of the first revascularization surgery. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Moyamoya Disease, Pediatrics, Cerebrovascular Disorders
- What is being tested?
- erythropoietin and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Apr 2019to 31 Dec 2023
- Phase
- Interventional
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric Moyamoya patients scheduled for the first revascularization surgery
Who cannot join
- Hypersensitivity or contraindication to rHuEPO
- History of Unstable hypertension, Hypertensive encephalopathy, Thrombosis
- Primary intracerebral hemorrhage (ICH), Subarachnoid hemorrhage (SAH), Arterio-venous malformation (AVM), Cerebral aneurysm, or cerebral neoplasm
- History of seizure
- Hemoglobin >16 mg/dl
- Prolonged PT (PT > 15.5 seconds, PT INR > 1.2) or Prolonged aPTT (> 40 seconds)
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- Thrombocytopenia (platelet count < 100,000/microL), Thrombocytosis (platelet count > 400,000/microL), Neutropenia (absolute neutrophil count (ANC) < 1500/microL)
- Abnormal kidney function (Creatinine> 2.0 mg/dl, History of dialysis)
- Abnormal hepatic function (aspartate transaminase> 80 unit/L, alanine aminotransferase> 80 unit/L)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Recombinant Human Erythropoietin on the Postoperative Neurologic Outcome in Pediatric Moyamoya Disease Patients - A Double Blind Randomized Controlled Trial
This study evaluates the effect of recombinant human erythropoietin (rHuEPO) on the neovascularization of pediatric moyamoya disease patients. rHuEPO will be administrated during perioperative period of the first revascularization surgery. Primary outcome (Incidence of Good postoperative MCA territory revascularization by cerebral angiography) will be evaluated after 3-6 month of revascularization surgery.
- Conditions
- Moyamoya Disease, Pediatrics, Cerebrovascular Disorders
- Being tested
- erythropoietin, Normal saline
- Medical subject headings
- Moyamoya Disease, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erythropoietinDrug
Also called rHuEPO
Recombinant human erythropoietin (500 U/kg IVS x 3 times) is administrated to increase the neovascularization after revascularization surgery.
Normal salineDrug
Also called Control
Control group, no intervention.
| Study group | Role | What they receive |
|---|---|---|
| rHuEPO | Experimental | recombinant human erythropoietin 500 U/kg IVS x 3 times Preoperative day (12-24 hour before surgery) During surgery Postoperative day (12-24 hour after surgery) Receives: Drug: erythropoietin |
| Control | Placebo comparator | Normal saline 50mL x 3 times Preoperative day (12-24 hour before surgery) During surgery Postoperative day (12-24 hour after surgery) Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative <12 month Angiogenesis
Incidence of Good postoperative MCA territory revascularization by cerebral angiography or MRI (3 grade: good, fair, poor)
Measured: <12 month after revascularization operation
Secondary outcomes (17)
Short-term postoperative outcome: Incidence and number of the postoperative transient ischemic attack (TIA) within 1 week
Incidence and number of the postoperative transient ischemic attack (TIA) within 1 week (yes or no)
Measured: up to 1 week
Short-term postoperative outcome: Adverse neurologic event
seizure, increased intracranial pressure, cerebral infarct, hematoma, reoperation (yes or no)
Measured: within the 1st postoperative hospital stay, up to 1 year
Short-term postoperative outcome: Other postoperative complications
e.g. Circulatory failure/arrest, Respiratory failure/arrest, Infection (yes or no)
Measured: within the 1st postoperative hospital stay, up to 1 year
Short-term postoperative outcome: ICU stay (days)
ICU stay (discharge criteria: Stable V/S + Consciousness)
Measured: within the 1st postoperative hospital stay, up to 1 year
Short-term postoperative outcome: Total hospital stay (days)
Total hospital stay (discharge criteria: Stable V/S + no progressive Sx)
Measured: within the 1st postoperative hospital stay, up to 1 year
Effect of rHuEPO on perioperative erythropoiesis: Total intraoperative and perioperative transfusion requirements (mL/kg)
Total intraoperative and perioperative transfusion requirements (mL/kg)
Measured: within the 1st postoperative hospital stay, up to 1 year
Effect of rHuEPO on perioperative erythropoiesis: Perioperative Hemoglobin, Hematocrit, serum EPO level
Perioperative Hemoglobin, Hematocrit, serum EPO level
Measured: within the 1st postoperative hospital stay, up to 1 year
Effect of rHuEPO on perioperative erythropoiesis: GFR, BUN, Creatinine
GFR, BUN, Creatinine level
Measured: within the 1st postoperative hospital stay, up to 1 year
Postoperative <12 month neurologic outcome: Clinical outcomes (4 grade): Excellent, Good, Fair, Poor
Clinical outcomes (4 grade): Excellent, Good, Fair, Poor
Measured: Outpatient clinical visit, Usually Postoperative 3~6 month, up to 1 year
Postoperative <12 month neurologic outcome: Brain Perfusion MRI (2 grade): Favorable, Unfavorable
Brain Perfusion MRI (2 grade): Favorable, Unfavorable
Measured: Outpatient clinical visit, Usually Postoperative 3~6 month, up to 1 year
Long-term neurologic outcome: Clinical outcomes (4 grade): Excellent, Good, Fair, Poor
Clinical outcomes (4 grade): Excellent, Good, Fair, Poor
Measured: Outpatient clinical visit, Usually Postoperative 12~18 month, up to 2 years
Long-term neurologic outcome: Brain MRI/A or Brain perfusion MRI
Brain MRI/A or Brain perfusion MRI (2 grade): Favorable, Unfavorable
Measured: Outpatient clinical visit, Usually Postoperative 12~18 month, up to 2 years
Long-term neurologic outcome: Cognitive function assessed by Korean Wechsler Intelligence Scale for Children-Ⅳ (K-WISC-Ⅳ)
Cognitive function assessed by Korean Wechsler Intelligence Scale for Children-Ⅳ (K-WISC-Ⅳ, has 4 domaines: Verbal Comprehension Index, Perceptual Reasoning Index, Working Memory Index, Processing Speed Index > final score is calculated from T-score)
Measured: Outpatient clinical visit, Usually Postoperative 12~18 month, up to 2 years
Preoperative Cerebral angiography: Suzuki grade, Bilateral involvement
Cerebral angiography: Suzuki grade(1-6), Bilateral involvement (yes/no)
Measured: Before up to 1 year
Preoperative Brain MRI/A or Brain Perfusion MRI
Brain MRI/A or Brain Perfusion MRI (2 grade): Favorable, Unfavorable
Measured: If the preoperative w/u is not completed before recruitment, up to 1 week
Preoperative Hemoglobin, Hematocrit, serum EPO level
Preoperative Hemoglobin, Hematocrit, serum EPO level
Measured: If the preoperative w/u is not completed before recruitment, up to 1 week
Preoperative information: Homozygous RNF213
Homozygous RNF213
Measured: If the preoperative w/u is not completed before recruitment, up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start8 Apr 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Moyamoya DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03882060
- Sponsor's protocol ID
- H-1812-165-999
- Status last verified
- Nov 2023
- First submitted
- 12 Mar 2019
- Last updated
- 22 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hong JM, Lee SJ, Lee JS, Choi MH, Lee SE, Choi JW, Lim YC. Feasibility of Multiple Burr Hole With Erythropoietin in Acute Moyamoya Patients. Stroke. 2018 May;49(5):1290-1295. doi: 10.1161/STROKEAHA.117.020566. Epub 2018 Apr 6.
PubMed 29626135Malla RR, Asimi R, Teli MA, Shaheen F, Bhat MA. Erythropoietin monotherapy in perinatal asphyxia with moderate to severe encephalopathy: a randomized placebo-controlled trial. J Perinatol. 2017 May;37(5):596-601. doi: 10.1038/jp.2017.17. Epub 2017 Mar 9.
PubMed 28277490Kimakova P, Solar P, Solarova Z, Komel R, Debeljak N. Erythropoietin and Its Angiogenic Activity. Int J Mol Sci. 2017 Jul 13;18(7):1519. doi: 10.3390/ijms18071519.
PubMed 28703764Aljaaly HA, Aldekhayel SA, Diaz-Abele J, Karunanayka M, Gilardino MS. Effect of Erythropoietin on Transfusion Requirements for Craniosynostosis Surgery in Children. J Craniofac Surg. 2017 Jul;28(5):1315-1319. doi: 10.1097/SCS.0000000000003717.
PubMed 28582302Wu YW, Mathur AM, Chang T, McKinstry RC, Mulkey SB, Mayock DE, Van Meurs KP, Rogers EE, Gonzalez FF, Comstock BA, Juul SE, Msall ME, Bonifacio SL, Glass HC, Massaro AN, Dong L, Tan KW, Heagerty PJ, Ballard RA. High-Dose Erythropoietin and Hypothermia for Hypoxic-Ischemic Encephalopathy: A Phase II Trial. Pediatrics. 2016 Jun;137(6):e20160191. doi: 10.1542/peds.2016-0191. Epub 2016 May 2.
PubMed 27244862Bang OY, Fujimura M, Kim SK. The Pathophysiology of Moyamoya Disease: An Update. J Stroke. 2016 Jan;18(1):12-20. doi: 10.5853/jos.2015.01760. Epub 2016 Jan 29.
PubMed 26846756Kim T, Oh CW, Bang JS, Kim JE, Cho WS. Moyamoya Disease: Treatment and Outcomes. J Stroke. 2016 Jan;18(1):21-30. doi: 10.5853/jos.2015.01739. Epub 2016 Jan 29.
PubMed 26846757Yoo YC, Shim JK, Kim JC, Jo YY, Lee JH, Kwak YL. Effect of single recombinant human erythropoietin injection on transfusion requirements in preoperatively anemic patients undergoing valvular heart surgery. Anesthesiology. 2011 Nov;115(5):929-37. doi: 10.1097/ALN.0b013e318232004b.
PubMed 22027622Kim SK, Cho BK, Phi JH, Lee JY, Chae JH, Kim KJ, Hwang YS, Kim IO, Lee DS, Lee J, Wang KC. Pediatric moyamoya disease: An analysis of 410 consecutive cases. Ann Neurol. 2010 Jul;68(1):92-101. doi: 10.1002/ana.21981.
PubMed 20582955Kim JH, Jung JH, Phi JH, Kang HS, Kim JE, Chae JH, Kim SJ, Kim YH, Kim YY, Cho BK, Wang KC, Kim SK. Decreased level and defective function of circulating endothelial progenitor cells in children with moyamoya disease. J Neurosci Res. 2010 Feb 15;88(3):510-8. doi: 10.1002/jnr.22228.
PubMed 19774676Heeschen 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 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Recombinant Human Erythropoietin on the Postoperative Neurologic Outcome in Pediatric Moyamoya Disease Patients - A Double Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03882060
- Acronym / sponsor ID
- H-1812-165-999
- Conditions
- Moyamoya Disease, Pediatrics, Cerebrovascular Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 20 Mar 2019 (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.
This study evaluates the effect of recombinant human erythropoietin (rHuEPO) on the neovascularization of pediatric moyamoya disease patients. rHuEPO will be administrated during perioperative period of the first revascularization surgery. Primary outcome (Incidence of Good postoperative MCA territory revascularization by cerebral angiography) will be evaluated after 3-6 month of revascularization surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rHuEPO | Experimental | Drug: erythropoietinrecombinant human erythropoietin 500 U/kg IVS x 3 times Preoperative day (12-24 hour before surgery) During surgery Postoperative day (12-24 hour after surgery) |
| Control | Placebo comparator | Drug: Normal salineNormal saline 50mL x 3 times Preoperative day (12-24 hour before surgery) During surgery Postoperative day (12-24 hour after surgery) |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Pediatric Moyamoya patients scheduled for the first revascularization surgery
Key exclusion criteria (9 listed)
- Hypersensitivity or contraindication to rHuEPO
- History of Unstable hypertension, Hypertensive encephalopathy, Thrombosis
- Primary intracerebral hemorrhage (ICH), Subarachnoid hemorrhage (SAH), Arterio-venous malformation (AVM), Cerebral aneurysm, or cerebral neoplasm
- History of seizure
- Hemoglobin >16 mg/dl
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 |
|---|---|---|
| erythropoietinAlso: rHuEPORecombinant human erythropoietin (500 U/kg IVS x 3 times) is administrated to increase the neovascularization after revascularization surgery. | Drug | rHuEPO |
| Normal salineAlso: ControlControl group, no intervention. | Drug | Control |
Primary outcome
postoperative <12 month Angiogenesis
Time frame: <12 month after revascularization operation
Incidence of Good postoperative MCA territory revascularization by cerebral angiography or MRI (3 grade: good, fair, poor)
17 secondary outcomes
Short-term postoperative outcome: Incidence and number of the postoperative transient ischemic attack (TIA) within 1 week
Time frame: up to 1 week
Short-term postoperative outcome: Adverse neurologic event
Time frame: within the 1st postoperative hospital stay, up to 1 year
Short-term postoperative outcome: Other postoperative complications
Time frame: within the 1st postoperative hospital stay, up to 1 year
Short-term postoperative outcome: ICU stay (days)
Time frame: within the 1st postoperative hospital stay, up to 1 year
Short-term postoperative outcome: Total hospital stay (days)
Time frame: within the 1st postoperative hospital stay, up to 1 year
Effect of rHuEPO on perioperative erythropoiesis: Total intraoperative and perioperative transfusion requirements (mL/kg)
Time frame: within the 1st postoperative hospital stay, up to 1 year
Effect of rHuEPO on perioperative erythropoiesis: Perioperative Hemoglobin, Hematocrit, serum EPO level
Time frame: within the 1st postoperative hospital stay, up to 1 year
Effect of rHuEPO on perioperative erythropoiesis: GFR, BUN, Creatinine
Time frame: within the 1st postoperative hospital stay, up to 1 year
Postoperative <12 month neurologic outcome: Clinical outcomes (4 grade): Excellent, Good, Fair, Poor
Time frame: Outpatient clinical visit, Usually Postoperative 3~6 month, up to 1 year
Postoperative <12 month neurologic outcome: Brain Perfusion MRI (2 grade): Favorable, Unfavorable
Time frame: Outpatient clinical visit, Usually Postoperative 3~6 month, up to 1 year
Long-term neurologic outcome: Clinical outcomes (4 grade): Excellent, Good, Fair, Poor
Time frame: Outpatient clinical visit, Usually Postoperative 12~18 month, up to 2 years
Long-term neurologic outcome: Brain MRI/A or Brain perfusion MRI
Time frame: Outpatient clinical visit, Usually Postoperative 12~18 month, up to 2 years
Long-term neurologic outcome: Cognitive function assessed by Korean Wechsler Intelligence Scale for Children-Ⅳ (K-WISC-Ⅳ)
Time frame: Outpatient clinical visit, Usually Postoperative 12~18 month, up to 2 years
Preoperative Cerebral angiography: Suzuki grade, Bilateral involvement
Time frame: Before up to 1 year
Preoperative Brain MRI/A or Brain Perfusion MRI
Time frame: If the preoperative w/u is not completed before recruitment, up to 1 week
Preoperative Hemoglobin, Hematocrit, serum EPO level
Time frame: If the preoperative w/u is not completed before recruitment, up to 1 week
Preoperative information: Homozygous RNF213
Time frame: If the preoperative w/u is not completed before recruitment, up to 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Background: PubMed 29626135Hong JM, Lee SJ, Lee JS, Choi MH, Lee SE, Choi JW, Lim YC. Feasibility of Multiple Burr Hole With Erythropoietin in Acute Moyamoya Patients. Stroke. 2018 May;49(5):1290-1295. doi: 10.1161/STROKEAHA.117.020566. Epub 2018 Apr 6.
- Background: PubMed 28277490Malla RR, Asimi R, Teli MA, Shaheen F, Bhat MA. Erythropoietin monotherapy in perinatal asphyxia with moderate to severe encephalopathy: a randomized placebo-controlled trial. J Perinatol. 2017 May;37(5):596-601. doi: 10.1038/jp.2017.17. Epub 2017 Mar 9.
- Background: PubMed 28703764Kimakova P, Solar P, Solarova Z, Komel R, Debeljak N. Erythropoietin and Its Angiogenic Activity. Int J Mol Sci. 2017 Jul 13;18(7):1519. doi: 10.3390/ijms18071519.
- Background: PubMed 28582302Aljaaly HA, Aldekhayel SA, Diaz-Abele J, Karunanayka M, Gilardino MS. Effect of Erythropoietin on Transfusion Requirements for Craniosynostosis Surgery in Children. J Craniofac Surg. 2017 Jul;28(5):1315-1319. doi: 10.1097/SCS.0000000000003717.
- Background: PubMed 27244862Wu YW, Mathur AM, Chang T, McKinstry RC, Mulkey SB, Mayock DE, Van Meurs KP, Rogers EE, Gonzalez FF, Comstock BA, Juul SE, Msall ME, Bonifacio SL, Glass HC, Massaro AN, Dong L, Tan KW, Heagerty PJ, Ballard RA. High-Dose Erythropoietin and Hypothermia for Hypoxic-Ischemic Encephalopathy: A Phase II Trial. Pediatrics. 2016 Jun;137(6):e20160191. doi: 10.1542/peds.2016-0191. Epub 2016 May 2.
- Background: PubMed 26846756Bang OY, Fujimura M, Kim SK. The Pathophysiology of Moyamoya Disease: An Update. J Stroke. 2016 Jan;18(1):12-20. doi: 10.5853/jos.2015.01760. Epub 2016 Jan 29.
- Background: PubMed 26846757Kim T, Oh CW, Bang JS, Kim JE, Cho WS. Moyamoya Disease: Treatment and Outcomes. J Stroke. 2016 Jan;18(1):21-30. doi: 10.5853/jos.2015.01739. Epub 2016 Jan 29.
- Background: PubMed 22027622Yoo YC, Shim JK, Kim JC, Jo YY, Lee JH, Kwak YL. Effect of single recombinant human erythropoietin injection on transfusion requirements in preoperatively anemic patients undergoing valvular heart surgery. Anesthesiology. 2011 Nov;115(5):929-37. doi: 10.1097/ALN.0b013e318232004b.
- Background: PubMed 20582955Kim SK, Cho BK, Phi JH, Lee JY, Chae JH, Kim KJ, Hwang YS, Kim IO, Lee DS, Lee J, Wang KC. Pediatric moyamoya disease: An analysis of 410 consecutive cases. Ann Neurol. 2010 Jul;68(1):92-101. doi: 10.1002/ana.21981.
- Background: PubMed 19774676Kim JH, Jung JH, Phi JH, Kang HS, Kim JE, Chae JH, Kim SJ, Kim YH, Kim YY, Cho BK, Wang KC, Kim SK. Decreased level and defective function of circulating endothelial progenitor cells in children with moyamoya disease. J Neurosci Res. 2010 Feb 15;88(3):510-8. doi: 10.1002/jnr.22228.
- Background: PubMed 12702503Heeschen 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.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing erythropoietin and Normal saline in people with Moyamoya Disease and Pediatrics, run by Seoul National University Hospital at 1 site in South Korea.
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 1 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 22 Nov 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 South Korea. 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?
Results are not available in the source record.
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?
postoperative <12 month Angiogenesis (time frame: <12 month after revascularization operation). 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 NCT03882060, which also lists 11 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 22 Nov 2023.