Prognosis Association of Hypocalcemia on Moderate-severe... | NCT01236911

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

NCT01236911

Sponsor

Universidad Autonoma de San Luis Potosí

Status

Unknown status

Last Update Posted

Nov 9, 2010Estimated

Enrollment

20Estimated

Phase

Not provided

Conditions

Calcium , Prognosis in Patients

Interventions

Calcium Measurement

Countries

Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Sep 2012Estimated

Completion Date

Nov 2012Estimated

First Submitted Date

Nov 8, 2010

First Submission Date that Met QC Criteria

Nov 8, 2010

First Posted Date

Nov 9, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 8, 2010

Last Update Posted Date

Nov 9, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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?

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Calcium Measurement	Other	after moderate-severe TBI (less as 24 hrs)	Calcium after moderate-severe TBI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Identify the more relevant prognosis factors		2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder 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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Juan manuel Viñas, M.D.	Contact	0052 44 48 262344	519	weinweg21@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Juan Manuel Viñas Rios	Recruiting	San Luis Potosí City	San Luis Potosí	78210	Mexico