Trial Outcomes & Findings for Non-Interventional Study About Treatment of Hemorrhages in Thyroid Surgery With TachoSil® (NCT NCT00700141)
NCT ID: NCT00700141
Last Updated: 2012-05-08
Results Overview
Handling (1= very good to 10= very poor) Satisfaction (1= very satisfied to 10= totally unsatisfied) Utility (1= very useful to 10= completely useless)
COMPLETED
482 participants
after surgery
2012-05-08
Participant Flow
Participant milestones
| Measure |
TachoSil® Application
Patients with application of at least one fleece of TachoSil® during thyroid surgery
|
|---|---|
|
Overall Study
STARTED
|
482
|
|
Overall Study
COMPLETED
|
482
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Non-Interventional Study About Treatment of Hemorrhages in Thyroid Surgery With TachoSil®
Baseline characteristics by cohort
| Measure |
TachoSil® Application
n=482 Participants
Patients with application of at least one fleece of TachoSil® during thyroid surgery
|
|---|---|
|
Age Continuous
between 15 and 91 years
|
53.33 years
STANDARD_DEVIATION 14.39 • n=99 Participants
|
|
Sex: Female, Male
Female
|
343 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
139 Participants
n=99 Participants
|
|
Number of Participants with the Indicated Hemorrhagic Risk Present
Application of medicines affecting coagulation
|
96 participants
n=99 Participants
|
|
Number of Participants with the Indicated Hemorrhagic Risk Present
Hereditary coagulation disorders
|
4 participants
n=99 Participants
|
|
Number of Participants with the Indicated Hemorrhagic Risk Present
Liver function disorders
|
3 participants
n=99 Participants
|
|
Number of Participants with the Indicated Hemorrhagic Risk Present
Disturbance of the thrombocyte hemostasis
|
9 participants
n=99 Participants
|
|
Number of Participants with the Indicated Hemorrhagic Risk Present
Other risks (M.Basedow, thyroiditis, tumor)
|
47 participants
n=99 Participants
|
|
Number of Participants with the Indicated Hemorrhagic Risk Present
Hyperparathyroidism
|
80 participants
n=99 Participants
|
|
Type of surgery
Enuc
|
5 participants
n=99 Participants
|
|
Type of surgery
1-ST
|
25 participants
n=99 Participants
|
|
Type of surgery
HT
|
83 participants
n=99 Participants
|
|
Type of surgery
2-ST
|
82 participants
n=99 Participants
|
|
Type of surgery
HT+ST
|
70 participants
n=99 Participants
|
|
Type of surgery
TE
|
217 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: after surgeryPopulation: 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)
Handling (1= very good to 10= very poor) Satisfaction (1= very satisfied to 10= totally unsatisfied) Utility (1= very useful to 10= completely useless)
Outcome measures
| Measure |
TachoSil® Application
n=481 Participants
Patients with application of at least one fleece of TachoSil® during thyroid surgery
|
|---|---|
|
Assessment of TachoSil® by the Surgeon With Respect to Handling, Utility and Satisfaction in the Operation, Documented Using 10 Point Numerical Rating Scales
Handling
|
2.54 Units on a scale
Standard Deviation 1.52
|
|
Assessment of TachoSil® by the Surgeon With Respect to Handling, Utility and Satisfaction in the Operation, Documented Using 10 Point Numerical Rating Scales
Satisfaction
|
2.25 Units on a scale
Standard Deviation 1.80
|
|
Assessment of TachoSil® by the Surgeon With Respect to Handling, Utility and Satisfaction in the Operation, Documented Using 10 Point Numerical Rating Scales
Utility
|
2.42 Units on a scale
Standard Deviation 1.63
|
SECONDARY outcome
Timeframe: peri- and post-surgery until hospital dischargePopulation: All 482 patients included and treated with TachoSil®, missing values not imputed. Multiple answers possible.
Question: What benefits resulted from the application of TachoSil® during this operation? (different categories to be answered with yes/no)
Outcome measures
| Measure |
TachoSil® Application
n=482 Participants
Patients with application of at least one fleece of TachoSil® during thyroid surgery
|
|---|---|
|
Pharmacoeconomic Benefits as Assessed by the Surgeon
Nerve sparing through atraumatic procedure
|
355 participants
|
|
Pharmacoeconomic Benefits as Assessed by the Surgeon
Saving/Shortening of operation time
|
286 participants
|
|
Pharmacoeconomic Benefits as Assessed by the Surgeon
Reduced probability of postoperative complications
|
277 participants
|
|
Pharmacoeconomic Benefits as Assessed by the Surgeon
Reduced time in overall length of hospital stay
|
83 participants
|
|
Pharmacoeconomic Benefits as Assessed by the Surgeon
Saving of erythrocyte concentrates
|
44 participants
|
|
Pharmacoeconomic Benefits as Assessed by the Surgeon
Saving of thrombocyte concentrates
|
30 participants
|
|
Pharmacoeconomic Benefits as Assessed by the Surgeon
Reduced time in intensive care unit
|
27 participants
|
|
Pharmacoeconomic Benefits as Assessed by the Surgeon
Saving of Fresh Frozen Plasma (FFP)
|
26 participants
|
Adverse Events
TachoSil® Application
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place