NCT00279383

Brief Summary

OSHES (= Observational Study on Hemostasis in Surgery) is a non interventional register settled in Italy with the purpose of collecting data on 800 patients intra-operatively treated with hemostatic supporting agents/techniques in addition to the standard surgical procedures in 40 surgical wards. The availability of these data will allow for a better understanding of the therapeutic needs in the area of hemostatic supporting agents/techniques.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2005

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2006

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 19, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

May 7, 2012

Status Verified

January 1, 2009

Enrollment Period

2.7 years

First QC Date

January 12, 2006

Last Update Submit

May 4, 2012

Conditions

Blood Loss, SurgicalHemostasis

Keywords

Intra-operatively treated patients with hemostatic supporting agents/techniques in addition to the standard surgical procedures

Interventions

Fibrinogen (human) + thrombin (human) (TachoSil)DRUG

Intra-operatively treated patients with hemostatic supporting agents/techniques in addition to the standard surgical procedures

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who are candidates for a specific type of surgery where a supportive hemostyptic agent will be used and who issued an informed consent. A special procedure will be implemented for use in emergency situations.

You may qualify if:

  • Patients who are candidates for a specific type of surgery where a supportive hemostyptic agent will be used and who issued an informed consent. A special procedure will be implemented for use in emergency situations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nycomed

Roskilde, Denmark

Location

MeSH Terms

Conditions

Blood Loss, Surgical

Interventions

FibrinogenThrombinTachoSil

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsIntraoperative Complications

Intervention Hierarchy (Ancestors)

Acute-Phase ProteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsBlood Coagulation FactorsProtein PrecursorsBiological FactorsSerine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine Proteases

Study Officials

  • Nycomed Clinical Trial Operations

    Headquarters

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 12, 2006

First Posted

January 19, 2006

Study Start

August 1, 2005

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

May 7, 2012

Record last verified: 2009-01

Locations

DK(1)