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Prognosis Association of Hypocalcemia on Moderate-severe TBI, COHORTE STUDY

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2010 by Universidad Autonoma de San Luis Potosí.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01236911
First Posted: November 9, 2010
Last Update Posted: November 9, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Universidad Autonoma de San Luis Potosí
  Purpose
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?

Condition Intervention
Calcium , Prognosis in Patients Other: Calcium Measurement

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Universidad Autonoma de San Luis Potosí:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Identify the more relevant prognosis factors [ Time Frame: 2 years ]

Estimated Enrollment: 20
Study Start Date: October 2010
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Other: Calcium Measurement
after moderate-severe TBI (less as 24 hrs)

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

  • Man - woman between 16-65 years old with moderate -severe TBI less as 24 hrs,Count with tomographic study

Exclusion Criteria:

  • Use of steroids, use of statins, Administration of Tromethamine, calcium antagonists, fibrates, niacin, cyclosporine, macrolides.
  • Unclassifiable lesions in brainstem
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01236911


Contacts
Contact: Juan manuel Viñas, M.D. 0052 44 48 262344 ext 519 weinweg21@hotmail.com

Locations
Mexico
Juan Manuel Viñas Rios Recruiting
San Luis Potosi, Mexico, 78210
Contact: Juan Manuel Viñas, M.D.    0052 44 48 26 23 44 ext 519    weinweg21@hotmail.com   
Sponsors and Collaborators
Universidad Autonoma de San Luis Potosí
  More Information

Responsible Party: Juan Manuel Viñas Rios, UASLP fACULTY OF MEDICINE
ClinicalTrials.gov Identifier: NCT01236911     History of Changes
Other Study ID Numbers: NCT071110
First Submitted: November 8, 2010
First Posted: November 9, 2010
Last Update Posted: November 9, 2010
Last Verified: November 2010

Keywords provided by Universidad Autonoma de San Luis Potosí:
Calcium , TBI,complications, days in hospital

Additional relevant MeSH terms:
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs