Non-interventional Trial About Treatment of Haemorrhages... | NCT00546169

Studies
Non-interventional Trial About Treatment of Haemorrhages in Cholecystectomy With TachoSil (TC-027-DE)

NCT00546169

Sponsor

Nycomed

Status

Completed

Last Update Posted

May 7, 2012Estimated

Enrollment

500Estimated

Phase

Not provided

Conditions

Hemorrhage

Interventions

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

Countries

Denmark

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

Aug 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2007

Primary Completion Date

Jun 2008Actual

Completion Date

Jul 2008Actual

First Submitted Date

Oct 17, 2007

First Submission Date that Met QC Criteria

Oct 17, 2007

First Posted Date

Oct 18, 2007Estimated

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

May 4, 2012

Last Update Posted Date

May 7, 2012Estimated

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

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.

Detailed Description

Not provided

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

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A			Drug: Fibrinogen (human) + thrombin (human) (TachoSil)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fibrinogen (human) + thrombin (human) (TachoSil)	Drug	haemorrhages in cholecystectomy	A

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

care clinic

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nycomed Clinical Trial Operations	Headquaters	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nycomed		Roskilde		4000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D006470	Hemorrhage

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005340	Fibrinogen
D013917	Thrombin
C518955	TachoSil

Ancestor Terms

ID	Term
D000209	Acute-Phase Proteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins

Browse Leaves

Not provided

Browse Branches

Not provided