Calcium , Prognosis in PatientsNCT01236911
Prognosis Association of Hypocalcemia on Moderate-severe TBI, COHORTE STUDY
An observational study of Calcium , Prognosis in Patients, run by Universidad Autonoma de San Luis Potosí at 1 site in Mexico.
Trial summary
Will have bad prognosis the patients with low calcium (less of 24 hrs of te admission in hospital)after moderate - severe TBI that the patients that do not developed this condition? Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Calcium , Prognosis in Patients
- What is being tested?
- Calcium Measurement
- How many people
- 20 participants
- Where
- 1 siteMexico
- Study dates
- Oct 2010to Nov 2012
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients bettween 16 and 65 years old with moderate -severe TBI with less as 24 hours , without administration of steroids or statins
Who may be able to join
- Man - woman between 16-65 years old with moderate -severe TBI less as 24 hrs,Count with tomographic study
Who cannot join
- Use of steroids, use of statins, Administration of Tromethamine, calcium antagonists, fibrates, niacin, cyclosporine, macrolides.
- Unclassifiable lesions in brainstem
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Juan Manuel Viñas Rios
San Luis Potosí City, San Luis Potosí, 78210
Juan Manuel Viñas, M.D., 0052 44 48 26 23 44 ext. 519, weinweg21@hotmail.com
About this study
Will have bad prognosis the patients with low calcium (less of 24 hrs of te admission in hospital)after moderate - severe TBI that the patients that do not developed this condition?
Read the detailed description
Through the years the investigators have seen that the patients with low calcium after moderate-severe TBI had bad prognosis including more complications, and more days in hospital. The investigators want to make an association between the patients that developed this condition and the patients that do not developed this condition
- Conditions
- Calcium , Prognosis in Patients
- Being tested
- Calcium Measurement
- Keywords
- Calcium , TBI,complications, days in hospital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium MeasurementOther
after moderate-severe TBI (less as 24 hrs)
| Study group | Role | What they receive |
|---|---|---|
| Calcium after moderate-severe TBI | Patients with moderate -severe TBI with less as 24 hrs , admitted in emergency. We will measure seric calcium to compare the differences between both groups Receives: Other: Calcium Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establishment an association between the patients that developed Hypocalcemia less 24 hrs after moderate-severe TBI with patients that did not develop this condition
Measured: 2 years
Secondary outcomes (1)
Identify the more relevant prognosis factors
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionSep 2012 (estimated)
- Study completionNov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Calcium , Prognosis in PatientsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de San Luis Potosí
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01236911
- Sponsor's protocol ID
- NCT071110
- Status last verified
- Nov 2010
- First submitted
- 8 Nov 2010
- Last updated
- 9 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis Association of Hypocalcemia on Moderate-severe TBI, COHORTE STUDY
- ClinicalTrials.gov ID
- NCT01236911
- Acronym / sponsor ID
- NCT071110
- Conditions
- Calcium , Prognosis in Patients
- Keywords
- Calcium , TBI,complications, days in hospital
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universidad Autonoma de San Luis PotosíUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 9 Nov 2010 (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.
Will have bad prognosis the patients with low calcium (less of 24 hrs of te admission in hospital)after moderate - severe TBI that the patients that do not developed this condition?
Detailed description
Through the years the investigators have seen that the patients with low calcium after moderate-severe TBI had bad prognosis including more complications, and more days in hospital. The investigators want to make an association between the patients that developed this condition and the patients that do not developed this condition
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Calcium after moderate-severe TBI | – | Other: Calcium MeasurementPatients with moderate -severe TBI with less as 24 hrs , admitted in emergency. We will measure seric calcium to compare the differences between both groups |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients bettween 16 and 65 years old with moderate -severe TBI with less as 24 hours , without administration of steroids or statins
Key inclusion criteria (1 listed)
- Man - woman between 16-65 years old with moderate -severe TBI less as 24 hrs,Count with tomographic study
Key exclusion criteria (2 listed)
- Use of steroids, use of statins, Administration of Tromethamine, calcium antagonists, fibrates, niacin, cyclosporine, macrolides.
- Unclassifiable lesions in brainstem
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 |
|---|---|---|
| Calcium Measurementafter moderate-severe TBI (less as 24 hrs) | Other | Calcium after moderate-severe TBI |
Primary outcome
Establishment an association between the patients that developed Hypocalcemia less 24 hrs after moderate-severe TBI with patients that did not develop this condition
Time frame: 2 years
1 secondary outcome
Identify the more relevant prognosis factors
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2010.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Calcium , Prognosis in Patients, run by Universidad Autonoma de San Luis Potosí at 1 site in Mexico.
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 2 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 9 Nov 2010. 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 Mexico. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan manuel Viñas, M.D. (0052 44 48 262344 ext. 519, weinweg21@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establishment an association between the patients that developed Hypocalcemia less 24 hrs after moderate-severe TBI with patients that did not develop this condition (time frame: 2 years). 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 9 Nov 2010.