Relationship Between Erythropoietin Administration and St... | NCT00622934

Studies
Relationship Between Erythropoietin Administration and Stress Responses in Trauma Patients

NCT00622934

Sponsor

Tehran University of Medical Sciences

Status

Unknown status

Last Update Posted

Nov 18, 2010Estimated

Enrollment

20Estimated

Phase

Phase 2

Conditions

Multiple Trauma

Interventions

erythropoietin
placebo

Countries

Iran

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

Jul 2007

Primary Completion Date

May 2008Estimated

Completion Date

May 2008Estimated

First Submitted Date

Feb 13, 2008

First Submission Date that Met QC Criteria

Feb 21, 2008

First Posted Date

Feb 25, 2008Estimated

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 17, 2010

Last Update Posted Date

Nov 18, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The purpose of this study is to determine whether Erythropoietin decrease stress responses and inflammation in trauma patient.

Detailed Description

Transfusion of blood products has many disadvantages. Erythropoietin is used to increase red blood cells production and decrease such disadvantages.In some studies anti inflammatory effects is shown for Erythropoietin.

One of the most problems in the intensive care unit is stress response. we are going to evaluate effects of erythropoietin on oxidative stress and inflammation in trauma patient in intensive care unit.

Design Module

Study Type

Interventional

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator		Drug: erythropoietin
2	Placebo Comparator		Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
erythropoietin	Drug	300mg/kg erythropoietin 3 times on the first week of admission	1

Measure	Description	Time Frame
apachi 2 saps 30 days mortality		untill discharge

Measure	Description	Time Frame
30 days mortality		30 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All multiple trauma patients>16 years with informed consent

Exclusion Criteria:

Hypertension
Allergy
Erythroid leukemia
Pregnancy and breast feeding
Pre operative patient
Severe cardiovascular and cerebrovascular diseases
Thromboembolic disorders

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
mojtaba mojtahedzade	Contact	0982166701041		Mojtahed@sina.tums.ac.ir
mostafa mohammady	Contact	0982166735017		mohammady_m2007@yahoo.com

Overall Officials

Name	Affiliation	Role
MOJTABA MOJTAHEDZADE	TUMS	Study Chair
MOSTAFA MOHAMMADY	TUMS	Principal Investigator
MOJTABA MOJTAHED

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sina Hospital	Recruiting	Tehran			Iran

Condition Browse Module

MeSH Terms

ID	Term
D009104	Multiple Trauma

Ancestor Terms

ID	Term
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004921	Erythropoietin
D000068817	Epoetin Alfa

Ancestor Terms

ID	Term
D003115	Colony-Stimulating Factors
D006023	Glycoproteins
D006001	Glycoconjugates
D002241	Carbohydrates

Browse Leaves

Not provided

Browse Branches

Not provided