NCT01236911

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?

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 9, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

November 9, 2010

Status Verified

November 1, 2010

Enrollment Period

1.9 years

First QC Date

November 8, 2010

Last Update Submit

November 8, 2010

Conditions

Calcium , Prognosis in Patients

Keywords

Calcium , TBI,complications, days in hospital

Outcome Measures

Primary Outcomes (1)

  • Establishment an association between the patients that developed Hypocalcemia less 24 hrs after moderate-severe TBI with patients that did not develop this condition

    2 years

Secondary Outcomes (1)

  • Identify the more relevant prognosis factors

    2 years

Study Arms (1)

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

Interventions

Calcium MeasurementOTHER

after moderate-severe TBI (less as 24 hrs)

Calcium after moderate-severe TBI

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • Use of steroids, use of statins, Administration of Tromethamine, calcium antagonists, fibrates, niacin, cyclosporine, macrolides.
  • Unclassifiable lesions in brainstem

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Juan Manuel Viñas Rios

San Luis Potosí City, San Luis Potosí, 78210, Mexico

RECRUITING

Central Study Contacts

Juan manuel Viñas, M.D.

CONTACT

0052 44 48 262344weinweg21@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 8, 2010

First Posted

November 9, 2010

Study Start

October 1, 2010

Primary Completion

September 1, 2012

Study Completion

November 1, 2012

Last Updated

November 9, 2010

Record last verified: 2010-11

Locations

ME(1)