Non-Interventional Study About Treatment of Hemorrhages i... | NCT00700141

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assessment of TachoSil® by the Surgeon With Respect to Handling, Utility and Satisfaction in the Operation, Documented Using 10 Point Numerical Rating Scales	Handling (1= very good to 10= very poor) Satisfaction (1= very satisfied to 10= totally unsatisfied) Utility (1= very useful to 10= completely useless)	after surgery

Secondary Outcomes

Measure	Description	Time Frame
Pharmacoeconomic Benefits as Assessed by the Surgeon	Question: What benefits resulted from the application of TachoSil® during this operation? (different categories to be answered with yes/no)	peri- and post-surgery until hospital discharge

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Dr. Thomas D. Bethke, MD, MBA	Nycomed Deutschland GmbH, 78467 Konstanz, Germany	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Nycomed Deutschland GmbH		Aschaffenburg		63739	Germany
Nycomed Deutschland GmbH

Results Section

Participant Flow Module

ID	Title	Description
FG000	TachoSil® Application	Patients with application of at least one fleece of TachoSil® during thyroid surgery

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age Continuous

The measured value is related to the number of 465 subjects. This number differs from the overall number of baseline participants due to non-availability of this information for 17 subjects.

Mean

Standard Deviation

years

Title

Denominators

Categories

between 15 and 91 years

Title	Measurements
	BG00053.33± 14.39

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000343
Male	BG000139

Number of Participants with the Indicated Hemorrhagic Risk Present

Multiple risks are possible for 184 participants (out of a total of 482 participants) who are affected by preoperative hemorrhagic risk according to surgeon assessment

Number

participants

Title

Denominators

Categories

Application of medicines affecting coagulation

Title	Measurements
	BG00096

Hereditary coagulation disorders

Title	Measurements

Type of surgery

Enuc = Enucleation in one or both sides of the thyroid gland
1-ST = Subtotal or near-total resection of one side of the thyroid gland
HT = Total resection of one side of the thyroid gland= hemithyroidectomy
2-ST = Subtotal or near-total resection of both sides of the thyroid gland
HT+ST = Total resection of one side=hemithyroidectomy and subtotal or neartotal resection of the contralateral side
TE = Total resection of both lobes of the thyroid gland=thyroidectomy

Number

participants

Title

Denominators

Categories

Enuc

Title	Measurements
	BG0005

1-ST

Title	Measurements

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Assessment of TachoSil® by the Surgeon With Respect to Handling, Utility and Satisfaction in the Operation, Documented Using 10 Point Numerical Rating Scales

Handling (1= very good to 10= very poor) Satisfaction (1= very satisfied to 10= totally unsatisfied) Utility (1= very useful to 10= completely useless)

All 482 patients included and treated with TachoSil® [= Intention to Treat population (ITT)], missing values not imputed.

For one patient missing information in all three scales (Handling, Utility and Satisfaction in the Operation)

Posted

Mean

Standard Deviation

Units on a scale

after surgery

ID	Title	Description
OG000	TachoSil® Application	Patients with application of at least one fleece of TachoSil® during thyroid surgery

Units	Counts
Participants	OG000481

Title

Denominators

Categories

Handling

Title	Measurements
	OG0002.54± 1.52

Satisfaction

Title	Measurements
	OG0002.25± 1.80

Utility

Secondary

Pharmacoeconomic Benefits as Assessed by the Surgeon

Question: What benefits resulted from the application of TachoSil® during this operation? (different categories to be answered with yes/no)

All 482 patients included and treated with TachoSil®, missing values not imputed.

Multiple answers possible.

Posted

Number

participants

peri- and post-surgery until hospital discharge

ID	Title	Description
OG000	TachoSil® Application	Patients with application of at least one fleece of TachoSil® during thyroid surgery

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	TachoSil® Application	Patients with application of at least one fleece of TachoSil® during thyroid surgery			0	482	0	482

ID	Term
D006470	Hemorrhage
D013959	Thyroid Diseases

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D004700	Endocrine System Diseases