NCT00546169

Brief Summary

  • Effectiveness and reliability of TachoSil in cholecystectomy (elective and acute)
  • Evaluation of TachoSil in laparoscopic cholecystectomy
  • Risk profile of patient under anticoagulant therapy undergoing acute cholecystectomy
  • Pharmaco-economic evaluation
  • Recording of AE's/SAE's Considering the total number of cholecystectomies in Germany (170.000 cases/y), out of them about 75% laparoscopic and 10.000 conversions totally it seems urgent to record data about usage of TachoSil in such procedures. For the time being TachoSil is applied in about 2% of the gall bladder procedures. Aim is to evaluate a possible patient and procedure profile where TachoSil is most beneficial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2007

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

June 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 18, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

May 7, 2012

Status Verified

August 1, 2008

Enrollment Period

1 year

First QC Date

October 17, 2007

Last Update Submit

May 4, 2012

Conditions

Hemorrhage

Keywords

Patients undergoing elective or acute cholecystectomy

Study Arms (1)

A

Drug: Fibrinogen (human) + thrombin (human) (TachoSil)

Interventions

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

haemorrhages in cholecystectomy

A

Eligibility Criteria

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

care clinic

You may qualify if:

  • Patients undergoing elective or acute cholecystectomy
  • The only restrictions of use will be those resulting from the contraindications (see section 4.3 of the Summary of Product Characteristics)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nycomed

Roskilde, 4000, Denmark

Location

MeSH Terms

Conditions

Hemorrhage

Interventions

FibrinogenThrombinTachoSil

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

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

    Headquaters

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

October 17, 2007

First Posted

October 18, 2007

Study Start

June 1, 2007

Primary Completion

June 1, 2008

Study Completion

July 1, 2008

Last Updated

May 7, 2012

Record last verified: 2008-08

Locations

DK(1)