Brain InjuryNCT02428790
Gastrointestinal Transit Time in Patients With Severe Acquired Brain Injury
An observational study of Brain Injury and Constipation, run by University of Aarhus.
Trial summary
Empirically patients with acquired brain injury (ABI) are often constipated. This is a major clinical issue. Nevertheless, this has only been sparsely studied. The investigators will measure gastrointestinal transit time (GITT) in 30 patients with ABI, and compare this to healthy controls. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Brain Injury, Constipation
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Nov 2015
- Phase
- Observational
- 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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients at Hammel Neurocenter and University Clinic, during rehabilitation after aquired brain injury
Who may be able to join
- ABI:
- Moderate to severe traumatic brain injury (TBI) (Glasgow Coma Scale (GCS) score 3-12 at admission)
- or Stroke
- or Anoxic brain injury
- Ability to swallow the capsules used to assess GITT
- Ability to give meaningful informed consent to participate in the study
Who cannot join
- Major abdominal disorders
- Severe acute comorbidity
- Known cancer
- Pregnancy
- Known autonomic neuropathy
- Other known neurological disorder
About this study
Empirically patients with acquired brain injury (ABI) are often constipated. This is a major clinical issue. Nevertheless, this has only been sparsely studied.
The investigators will measure gastrointestinal transit time (GITT) in 30 patients with ABI, and compare this to healthy controls. Secondly heart rate variability (HRV) is measured in these patients, and associations between HRV and GITT are investigated.
- Conditions
- Brain Injury, Constipation
- Medical subject headings
- Brain Injuries, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ABI Patients | Patients with acquired brain injury. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal transit time (GITT) [in days]
Measured: During rehabilitation, when the patient meet the inclusion criteria. This is expected to be between 2 weeks and 4 months after the primary injury.
Secondary outcomes (1)
Association between heart rate variability (HRV) and GITT
Linear regression with GITT as dependent variable, and high frequency power sepectral density analysis of the heart rate (HF) as the independent variable.
Measured: During rehabilitation, when the patient meet the inclusion criteria. This is expected to be between 2 weeks and 4 months after the primary injury.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Regionshospitalet Hammel Neurocenter
- Responsible party
- Sponsor
- Investigators
- Henning Andersen, Professor, Dr. med. PhD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02428790
- Sponsor's protocol ID
- ABITransitTimeHammel
- Status last verified
- Jan 2015
- First submitted
- 17 Apr 2015
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastrointestinal Transit Time in Patients With Severe Acquired Brain Injury
- ClinicalTrials.gov ID
- NCT02428790
- Acronym / sponsor ID
- ABITransitTimeHammel
- Conditions
- Brain Injury, Constipation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Regionshospitalet Hammel Neurocenter
- Study start
- May 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 29 Apr 2015 (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.
Empirically patients with acquired brain injury (ABI) are often constipated. This is a major clinical issue. Nevertheless, this has only been sparsely studied.
The investigators will measure gastrointestinal transit time (GITT) in 30 patients with ABI, and compare this to healthy controls. Secondly heart rate variability (HRV) is measured in these patients, and associations between HRV and GITT are investigated.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ABI Patients | – | –Patients with acquired brain injury. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at Hammel Neurocenter and University Clinic, during rehabilitation after aquired brain injury
Key inclusion criteria (6 listed)
- ABI:
- Moderate to severe traumatic brain injury (TBI) (Glasgow Coma Scale (GCS) score 3-12 at admission)
- or Stroke
- or Anoxic brain injury
- Ability to swallow the capsules used to assess GITT
Key exclusion criteria (6 listed)
- Major abdominal disorders
- Severe acute comorbidity
- Known cancer
- Pregnancy
- Known autonomic neuropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gastrointestinal transit time (GITT) [in days]
Time frame: During rehabilitation, when the patient meet the inclusion criteria. This is expected to be between 2 weeks and 4 months after the primary injury.
1 secondary outcome
Association between heart rate variability (HRV) and GITT
Time frame: During rehabilitation, when the patient meet the inclusion criteria. This is expected to be between 2 weeks and 4 months after the primary injury.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
Related trials for Brain Injury
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Recruiting
Telerehabilitation Compared With Clinic-Based Physiotherapy in Children With Spastic Cerebral Palsy
Spastic Cerebral Palsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
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.
Henning Andersen, Professor, Dr. med. PhD principal investigator
Aarhus University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injury and Constipation, run by University of Aarhus.
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 6 inclusion and 6 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: finished, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Gastrointestinal transit time (GITT) [in days] (time frame: During rehabilitation, when the patient meet the inclusion criteria. This is expected to be between 2 weeks and 4 months after the primary injury.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2015.