Prognosis Association of Hypocalcemia on Moderate-severe TBI, COHORTE STUDY
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Universidad Autonoma de San Luis Potosí.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Universidad Autonoma de San Luis Potosí
Information provided by:
Universidad Autonoma de San Luis Potosí
ClinicalTrials.gov Identifier:
NCT01236911
First received: November 8, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | November 8, 2010 | ||||
| Last Updated Date | November 8, 2010 | ||||
| Start Date ICMJE | October 2010 | ||||
| Estimated Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
Identify the more relevant prognosis factors [ Time Frame: 2 years ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Prognosis Association of Hypocalcemia on Moderate-severe TBI, COHORTE STUDY | ||||
| Official Title ICMJE | Not Provided | ||||
| Brief 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? |
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| 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 |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients bettween 16 and 65 years old with moderate -severe TBI with less as 24 hours , without administration of steroids or statins |
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| Condition ICMJE | Calcium , Prognosis in Patients | ||||
| Intervention ICMJE | Other: Calcium Measurement
after moderate-severe TBI (less as 24 hrs) |
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| Study Group/Cohort (s) | 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
Intervention: Other: Calcium Measurement |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 20 | ||||
| Estimated Completion Date | November 2012 | ||||
| Estimated Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 16 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Mexico | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01236911 | ||||
| Other Study ID Numbers ICMJE | NCT071110 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Juan Manuel Viñas Rios, UASLP fACULTY OF MEDICINE | ||||
| Study Sponsor ICMJE | Universidad Autonoma de San Luis Potosí | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Universidad Autonoma de San Luis Potosí | ||||
| Verification Date | November 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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