Traumatic Brain InjurySTBINCT06199778
Effect of Intermittent Oro-esophageal Tube Feeding on Severe Traumatic Brain Injury Patients With Tracheostomy
A study testing Rehabilitation therapy, Intermittent Oro-esophageal Tube Feeding and Nasogastric tube feeding in people with Traumatic Brain Injury, run by Zeng Changhao at 1 site in China.
Trial summary
This was a multicenter randomized controlled study of 98 severe Traumatic Brain Injury patients with tracheostomy. Patients enrolled were divided randomly into the observation group with Intermittent Oro-esophageal Tube Feeding (n=50) or the control group with Nasogastric tube feeding (n=48) for enteral nutrition… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Rehabilitation therapy, Intermittent Oro-esophageal Tube Feeding and Nasogastric tube feeding
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 15 Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 18 years, meeting the diagnosis of severe Traumatic Brain Injury, confirmed through MRI
- score of Glasgow Coma Scale (GCS) <8;
- presence of no contraindication for enteral nutrition;
- with stable vital signs and no severe liver or kidney dysfunction, metabolic disorders, cardiovascular diseases, or multiple complications;
- informed consent form was obtained from the patient\'s family members, indicating their full understanding of the study and agreement to participate.
Who cannot join
- unable to cooperate in completing treatment and assessment due to personal reasons or other disorders;
- complicated with other intracranial lesions, such as stroke;
- with severe consciousness disorders caused by other diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Study to Explore the Effect of Intermittent Oro-esophageal Tube Feeding on Severe Traumatic Brain Injury Patients With Tracheostomy
This was a multicenter randomized controlled study of 98 severe Traumatic Brain Injury patients with tracheostomy. Patients enrolled were divided randomly into the observation group with Intermittent Oro-esophageal Tube Feeding (n=50) or the control group with Nasogastric tube feeding (n=48) for enteral nutrition support, respectively. Nutritional status, complications, decannulation of tracheostomy tubes and level of consciousness on day 1 and day 28 were recorded and compared.
Read the detailed description
The safe and effective nutrition support for severe traumatic brain injury patients with tracheostomy continues to be a challenge. Nasogastric tube feeding has been the mainstream choice in China but with the risk of complications. Intermittent Oro-esophageal Tube Feeding is an established modality of enteral nutrition support that can be used with routine treatment. This study reports the clinical outcomes of Intermittent Oro-esophageal Tube Feeding vs. nasogastric tube feeding, in patients receiving routine treatment. This was a multicenter randomized controlled study of 98 severe traumatic brain injury patients with tracheostomy. Patients enrolled were divided randomly into the observation group with Intermittent Oro-esophageal Tube Feeding (n=50) or the control group with Nasogastric tube feeding (n=48) for enteral nutrition support, respectively. Nutritional status, complications, decannulation of tracheostomy tubes and level of consciousness on day 1 and day 28 were recorded and compared.
- Conditions
- Traumatic Brain Injury
- Being tested
- Rehabilitation therapy, Intermittent Oro-esophageal Tube Feeding, Nasogastric tube feeding, Reserpine, Levofloxacin
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation therapyBehavioural
- Acupuncture: Regular acupuncture treatment that can prevent muscle atrophy, improve circulation, and have a stimulating effect.
- Exercise therapy: Training that focused on limb movements or joint mobilization to prevent muscle contracture, reduce joint mobility, improve spasms, and promote blood circulation.
- Others: Regular turning, back patting, and position changes performed by caregivers.
Intermittent Oro-esophageal Tube FeedingDevice
Based on this, the patients in the observation group were given nutrition support with Intermittent Oro-esophageal Tube Feeding (Medical Device No. 20010234, developed by the Swallowing Disorders Research Institute of Zhengzhou University). The entire feeding process strictly followed the standard procedure of Intermittent Oro-esophageal Tube Feeding(18). During the feeding process, patients were maintained in a semi-recumbent position with their head elevated, facilitating the placement of the tube into the oral cavity along one side, with the chin brought close to the manubrium sterni.
Nasogastric tube feedingDevice
The patients in the control group were provided nutrition support with Nasogastric tube feeding, while the feeding process strictly followed the relevant guideline. During the treatment, the patients remained in a continuous state of tube indwelling, receiving feeding every 2-3 hours with a maximum feeding volume of 200ml, of which the contents were consistent with the observation group. The entire feeding process was conducted by trained nursing staff. Besides, the tube was replaced by a new one every 5-7 days.
ReserpineDrug
Also called neurotrophic drugs
Reserpine was administered to patients to nourish their nerves, with frequency based on their condition.
LevofloxacinDrug
Also called antibiotic
The levofloxacin was administered to patients as antibiotic treatment, with frequency based on their condition.
| Study group | Role | What they receive |
|---|---|---|
| the observation group | Experimental | Both groups of patients were provided with routine treatments, including pharmacological treatment, rehabilitation therapy.Based on this, the patients in the observation group were given enteral nutrition support with Intermittent Oro-esophageal Tube Feeding (Medical Device No. 20010234, developed by the Swallowing Disorders Research Institute of Zhengzhou University). Receives: Behavioral: Rehabilitation therapy; Device: Intermittent Oro-esophageal Tube Feeding; Drug: Reserpine; Drug: Levofloxacin |
| the control group | Active comparator | Both groups of patients were provided with routine treatments, including pharmacological treatment, rehabilitation therapy. The patients in the control group were provided nutrition support with Nasogastric tube feeding , while the feeding process strictly followed the relevant guideline Receives: Behavioral: Rehabilitation therapy; Device: Nasogastric tube feeding; Drug: Reserpine; Drug: Levofloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of hemoglobin
hemoglobin was tested with blood routine test
Measured: day 1 and day 28
Concentration of albumin
albumin was tested with blood routine test
Measured: day 1 and day 28
Concentration of prealbumin
prealbumin was tested with blood routine test
Measured: day 1 and day 28
Nutritional status-body mass index
body mass index was tested with body weight and height. Combination was calculated as: body weight (kg) / height (m)^2.
Measured: day 1 and day 28
Secondary outcomes (9)
Complications-Pulmonary Infections
During the treatment, the occurrence of complications was recorded for both groups(24). These complications included but were not limited to: 1) Pulmonary Infections: Monitoring for the development of respiratory infections such as pneumonia or bronchitis.
Measured: Day 1 and day 28
Complications-Gastroesophageal Reflux
Gastroesophageal Reflux: Assessing the occurrence of reflux from the stomach into the esophagus, which can cause symptoms like heartburn and regurgitation.
Measured: up to 28 days
Complications- Gastrointestinal Bleeding
Observing for any signs of bleeding within the digestive tract, which may manifest as blood in the stool or vomiting of blood.
Measured: up to 28 days
Complications-Gastric Retention
Evaluating whether there was delayed emptying of the stomach contents, leading to symptoms such as bloating, nausea, and vomiting.
Measured: up to 28 days
Complications-Diarrhea
Monitoring for loose or watery stools, which may indicate gastrointestinal disturbances or medication side effects.
Measured: up to 28 days
Complications-Constipation
Assessing the occurrence of infrequent bowel movements or difficulty passing stools.
Measured: up to 28 days
Decannulation of tracheostomy tube-placement duration
The duration of tracheostomy tube retention and the outcomes of decannulation were recorded for two groups during the treatment. The criteria for tracheostomy tube removal were as follows: patients should exhibit no significant pulmonary complications (including the progressive decline in blood oxygen, carbon dioxide retention, pneumonia, etc.) during the capping trial, and should exhibit stable, regular breath and not require reintubation or tracheostomy within 72 hours after tube removal.
Measured: up to 28 days
Decannulation of tracheostomy tube-Successful removal
The duration of tracheostomy tube retention and the outcomes of decannulation were recorded for two groups during the treatment. The criteria for tracheostomy tube removal were as follows: patients should exhibit no significant pulmonary complications (including the progressive decline in blood oxygen, carbon dioxide retention, pneumonia, etc.) during the capping trial, and should exhibit stable, regular breath and not require reintubation or tracheostomy within 72 hours after tube removal
Measured: up to 28 days
Level of consciousness
The Glasgow Coma Scale was used to assess the level of consciousness in patients. A score of 15 indicates normal consciousness, a score of 13-14 indicates mild consciousness impairment, a score of 9-12 indicates moderate consciousness impairment, and a score less than 8 indicates severe consciousness impairment.
Measured: day 1 and day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start1 Jun 2022
- Primary completion13 May 2023
- Study completion15 Jun 2023
Why it stopped: ethical issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This was a prospective multicenter randomized controlled study, including severe Traumatic Brain Injury patients with tracheostomy transferred to the department of rehabilitation medicine in 3 hospitals from intensive care unit in China between June 2022 and June 2023. Patients enrolled were firstly numbered and then randomly divided into the observation group and the control group. In addition to routine treatments, Intermittent Oro-esophageal Tube Feeding or Nasogastric tube feeding, as nutrition support, was given to patients based on their group. The study lasted 4 weeks for each patient.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeng Changhao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zeng Changhao, People's Hospital of Zhengzhou University
- Investigators
- Nieto Luis, Doctor, Principal investigator, Site Coordinator of United Medical Group located in Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06199778
- Sponsor's protocol ID
- 2022-KY-1333
- Acronym
- STBI
- Status last verified
- Mar 2024
- First submitted
- 15 Dec 2023
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data were not publicly accessed, but can be obtained under a reasonable request from The First Affiliated Hospital of Zhengzhou University
Publications
Langlois JA, Rutland-Brown W, Wald MM. The epidemiology and impact of traumatic brain injury: a brief overview. J Head Trauma Rehabil. 2006 Sep-Oct;21(5):375-8. doi: 10.1097/00001199-200609000-00001.
PubMed 16983222Maas AIR, Menon DK, Adelson PD, Andelic N, Bell MJ, Belli A, Bragge P, Brazinova A, Buki A, Chesnut RM, Citerio G, Coburn M, Cooper DJ, Crowder AT, Czeiter E, Czosnyka M, Diaz-Arrastia R, Dreier JP, Duhaime AC, Ercole A, van Essen TA, Feigin VL, Gao G, Giacino J, Gonzalez-Lara LE, Gruen RL, Gupta D, Hartings JA, Hill S, Jiang JY, Ketharanathan N, Kompanje EJO, Lanyon L, Laureys S, Lecky F, Levin H, Lingsma HF, Maegele M, Majdan M, Manley G, Marsteller J, Mascia L, McFadyen C, Mondello S, Newcombe V, Palotie A, Parizel PM, Peul W, Piercy J, Polinder S, Puybasset L, Rasmussen TE, Rossaint R, Smielewski P, Soderberg J, Stanworth SJ, Stein MB, von Steinbuchel N, Stewart W, Steyerberg EW, Stocchetti N, Synnot A, Te Ao B, Tenovuo O, Theadom A, Tibboel D, Videtta W, Wang KKW, Williams WH, Wilson L, Yaffe K; InTBIR Participants and Investigators. Traumatic brain injury: integrated approaches to improve prevention, clinical care, and research. Lancet Neurol. 2017 Dec;16(12):987-1048. doi: 10.1016/S1474-4422(17)30371-X. Epub 2017 Nov 6. No abstract available.
PubMed 29122524Hawryluk GWJ, Rubiano AM, Totten AM, O'Reilly C, Ullman JS, Bratton SL, Chesnut R, Harris OA, Kissoon N, Shutter L, Tasker RC, Vavilala MS, Wilberger J, Wright DW, Lumba-Brown A, Ghajar J. Guidelines for the Management of Severe Traumatic Brain Injury: 2020 Update of the Decompressive Craniectomy Recommendations. Neurosurgery. 2020 Sep 1;87(3):427-434. doi: 10.1093/neuros/nyaa278.
PubMed 32761068
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study to Explore the Effect of Intermittent Oro-esophageal Tube Feeding on Severe Traumatic Brain Injury Patients With Tracheostomy
- ClinicalTrials.gov ID
- NCT06199778
- Acronym / sponsor ID
- STBI / 2022-KY-1333
- Conditions
- Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: ethical issues
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Zeng ChanghaoUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 13 May 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 10 Jan 2024 (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 was a multicenter randomized controlled study of 98 severe Traumatic Brain Injury patients with tracheostomy. Patients enrolled were divided randomly into the observation group with Intermittent Oro-esophageal Tube Feeding (n=50) or the control group with Nasogastric tube feeding (n=48) for enteral nutrition support, respectively. Nutritional status, complications, decannulation of tracheostomy tubes and level of consciousness on day 1 and day 28 were recorded and compared.
Detailed description
The safe and effective nutrition support for severe traumatic brain injury patients with tracheostomy continues to be a challenge. Nasogastric tube feeding has been the mainstream choice in China but with the risk of complications. Intermittent Oro-esophageal Tube Feeding is an established modality of enteral nutrition support that can be used with routine treatment. This study reports the clinical outcomes of Intermittent Oro-esophageal Tube Feeding vs. nasogastric tube feeding, in patients receiving routine treatment. This was a multicenter randomized controlled study of 98 severe traumatic brain injury patients with tracheostomy. Patients enrolled were divided randomly into the observation group with Intermittent Oro-esophageal Tube Feeding (n=50) or the control group with Nasogastric tube feeding (n=48) for enteral nutrition support, respectively. Nutritional status, complications, decannulation of tracheostomy tubes and level of consciousness on day 1 and day 28 were recorded and compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This was a prospective multicenter randomized controlled study, including severe Traumatic Brain Injury patients with tracheostomy transferred to the department of rehabilitation medicine in 3 hospitals from intensive care unit in China between June 2022 and June 2023. Patients enrolled were firstly numbered and then randomly divided into the observation group and the control group. In addition to routine treatments, Intermittent Oro-esophageal Tube Feeding or Nasogastric tube feeding, as nutrition support, was given to patients based on their group. The study lasted 4 weeks for each patient.
| Arm | Type | Receives |
|---|---|---|
| the observation group | Experimental | Behavioral: Rehabilitation therapy, Device: Intermittent Oro-esophageal Tube Feeding, Drug: Reserpine, Drug: LevofloxacinBoth groups of patients were provided with routine treatments, including pharmacological treatment, rehabilitation therapy.Based on this, the patients in the observation group were given enteral nutrition support with Intermittent Oro-esophageal Tube Feeding (Medical Device No. 20010234, developed by the Swallowing Disorders Research Institute of Zhengzhou University). |
| the control group | Active comparator | Behavioral: Rehabilitation therapy, Device: Nasogastric tube feeding, Drug: Reserpine, Drug: LevofloxacinBoth groups of patients were provided with routine treatments, including pharmacological treatment, rehabilitation therapy. The patients in the control group were provided nutrition support with Nasogastric tube feeding , while the feeding process strictly followed the relevant guideline |
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 the diagnosis of severe Traumatic Brain Injury, confirmed through MRI
- score of Glasgow Coma Scale (GCS) <8;
- presence of no contraindication for enteral nutrition;
- with stable vital signs and no severe liver or kidney dysfunction, metabolic disorders, cardiovascular diseases, or multiple complications;
- informed consent form was obtained from the patient\'s family members, indicating their full understanding of the study and agreement to participate.
Key exclusion criteria (3 listed)
- unable to cooperate in completing treatment and assessment due to personal reasons or other disorders;
- complicated with other intracranial lesions, such as stroke;
- with severe consciousness disorders caused by other diseases.
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 |
|---|---|---|
| Rehabilitation therapy1. Acupuncture: Regular acupuncture treatment that can prevent muscle atrophy, improve circulation, and have a stimulating effect. 2. Exercise therapy: Training that focused on limb movements or joint mobilization to prevent muscle contracture, reduce joint mobility, improve spasms, and promote blood circulation. 3. Others: Regular turning, back patting, and position changes performed by caregivers. | Behavioural | the control group, the observation group |
| Intermittent Oro-esophageal Tube FeedingBased on this, the patients in the observation group were given nutrition support with Intermittent Oro-esophageal Tube Feeding (Medical Device No. 20010234, developed by the Swallowing Disorders Research Institute of Zhengzhou University). The entire feeding process strictly followed the standard procedure of Intermittent Oro-esophageal Tube Feeding(18). During the feeding process, patients were maintained in a semi-recumbent position with their head elevated, facilitating the placement of the tube into the oral cavity along one side, with the chin brought close to the manubrium sterni. | Device | the observation group |
| Nasogastric tube feedingThe patients in the control group were provided nutrition support with Nasogastric tube feeding, while the feeding process strictly followed the relevant guideline. During the treatment, the patients remained in a continuous state of tube indwelling, receiving feeding every 2-3 hours with a maximum feeding volume of 200ml, of which the contents were consistent with the observation group. The entire feeding process was conducted by trained nursing staff. Besides, the tube was replaced by a new one every 5-7 days. | Device | the control group |
| ReserpineAlso: neurotrophic drugsReserpine was administered to patients to nourish their nerves, with frequency based on their condition. | Drug | the control group, the observation group |
| LevofloxacinAlso: antibioticThe levofloxacin was administered to patients as antibiotic treatment, with frequency based on their condition. | Drug | the control group, the observation group |
Primary outcome
Concentration of hemoglobin
Time frame: day 1 and day 28
hemoglobin was tested with blood routine test
Concentration of albumin
Time frame: day 1 and day 28
albumin was tested with blood routine test
Concentration of prealbumin
Time frame: day 1 and day 28
prealbumin was tested with blood routine test
Nutritional status-body mass index
Time frame: day 1 and day 28
body mass index was tested with body weight and height. Combination was calculated as: body weight (kg) / height (m)^2.
9 secondary outcomes
Complications-Pulmonary Infections
Time frame: Day 1 and day 28
Complications-Gastroesophageal Reflux
Time frame: up to 28 days
Complications- Gastrointestinal Bleeding
Time frame: up to 28 days
Complications-Gastric Retention
Time frame: up to 28 days
Complications-Diarrhea
Time frame: up to 28 days
Complications-Constipation
Time frame: up to 28 days
Decannulation of tracheostomy tube-placement duration
Time frame: up to 28 days
Decannulation of tracheostomy tube-Successful removal
Time frame: up to 28 days
Level of consciousness
Time frame: day 1 and day 28
Results and safety
The study was stopped early (reason given: ethical issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Background: PubMed 16983222Langlois JA, Rutland-Brown W, Wald MM. The epidemiology and impact of traumatic brain injury: a brief overview. J Head Trauma Rehabil. 2006 Sep-Oct;21(5):375-8. doi: 10.1097/00001199-200609000-00001.
- Background: PubMed 29122524Maas AIR, Menon DK, Adelson PD, Andelic N, Bell MJ, Belli A, Bragge P, Brazinova A, Buki A, Chesnut RM, Citerio G, Coburn M, Cooper DJ, Crowder AT, Czeiter E, Czosnyka M, Diaz-Arrastia R, Dreier JP, Duhaime AC, Ercole A, van Essen TA, Feigin VL, Gao G, Giacino J, Gonzalez-Lara LE, Gruen RL, Gupta D, Hartings JA, Hill S, Jiang JY, Ketharanathan N, Kompanje EJO, Lanyon L, Laureys S, Lecky F, Levin H, Lingsma HF, Maegele M, Majdan M, Manley G, Marsteller J, Mascia L, McFadyen C, Mondello S, Newcombe V, Palotie A, Parizel PM, Peul W, Piercy J, Polinder S, Puybasset L, Rasmussen TE, Rossaint R, Smielewski P, Soderberg J, Stanworth SJ, Stein MB, von Steinbuchel N, Stewart W, Steyerberg EW, Stocchetti N, Synnot A, Te Ao B, Tenovuo O, Theadom A, Tibboel D, Videtta W, Wang KKW, Williams WH, Wilson L, Yaffe K; InTBIR Participants and Investigators. Traumatic brain injury: integrated approaches to improve prevention, clinical care, and research. Lancet Neurol. 2017 Dec;16(12):987-1048. doi: 10.1016/S1474-4422(17)30371-X. Epub 2017 Nov 6. No abstract available.
- Background: PubMed 32761068Hawryluk GWJ, Rubiano AM, Totten AM, O'Reilly C, Ullman JS, Bratton SL, Chesnut R, Harris OA, Kissoon N, Shutter L, Tasker RC, Vavilala MS, Wilberger J, Wright DW, Lumba-Brown A, Ghajar J. Guidelines for the Management of Severe Traumatic Brain Injury: 2020 Update of the Decompressive Craniectomy Recommendations. Neurosurgery. 2020 Sep 1;87(3):427-434. doi: 10.1093/neuros/nyaa278.
- Individual participant dataSharing planned: No. Data were not publicly accessed, but can be obtained under a reasonable request from The First Affiliated Hospital of Zhengzhou University
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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.
Nieto Luis, Doctor principal investigator
Site Coordinator of United Medical Group located in Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation therapy, Intermittent Oro-esophageal Tube Feeding and Nasogastric tube feeding in people with Traumatic Brain Injury, run by Zeng Changhao 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 3 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: stopped early, as of the sponsor's last update on 5 Mar 2024. 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. 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?
The study was stopped early (reason given: ethical issues). 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?
Concentration of hemoglobin (time frame: day 1 and day 28). The study lists 4 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 NCT06199778, which also lists 3 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 5 Mar 2024.