NCT00622934

Brief Summary

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

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 phase_2

Timeline
Completed

Started Jul 2007

Shorter than P25 for phase_2

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

July 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 25, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

November 18, 2010

Status Verified

November 1, 2010

Enrollment Period

10 months

First QC Date

February 13, 2008

Last Update Submit

November 17, 2010

Conditions

Multiple Trauma

Keywords

multiple trauma

Outcome Measures

Primary Outcomes (1)

  • apachi 2 saps 30 days mortality

    untill discharge

Secondary Outcomes (1)

  • 30 days mortality

    30 days

Study Arms (2)

1

ACTIVE COMPARATOR
Drug: erythropoietin

2

PLACEBO COMPARATOR
Drug: placebo

Interventions

erythropoietinDRUG

300mg/kg erythropoietin 3 times on the first week of admission

Also known as: EPREX
1
placeboDRUG

placebo

2

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All multiple trauma patients\>16 years with informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sina Hospital

Tehran, Iran

RECRUITING

MeSH Terms

Conditions

Multiple Trauma

Interventions

ErythropoietinEpoetin Alfa

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • MOJTABA MOJTAHEDZADE

    TUMS

    STUDY CHAIR

  • MOSTAFA MOHAMMADY

    TUMS

    PRINCIPAL INVESTIGATOR

  • MOJTABA MOJTAHED

    TUMS

    STUDY DIRECTOR

Central Study Contacts

mojtaba mojtahedzade

CONTACT

0982166701041Mojtahed@sina.tums.ac.ir

mostafa mohammady

CONTACT

0982166735017mohammady_m2007@yahoo.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 13, 2008

First Posted

February 25, 2008

Study Start

July 1, 2007

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

November 18, 2010

Record last verified: 2010-11

Locations

IR(1)