Trial Outcomes & Findings for Impact of SSKI Pre-Treatment on Blood Loss in Thyroidectomy for Graves Disease (NCT NCT00946296)
NCT ID: NCT00946296
Last Updated: 2015-12-15
Results Overview
Blood loss in milliliters during surgery.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
36 participants
Primary outcome timeframe
up to 162 minutes
Results posted on
2015-12-15
Participant Flow
Between October 2005 and April 2013, subjects who had been determined to undergo thyroidectomy for definitive management of Graves Disease, were approached for participation in the study. Recruitment occurred in the endocrine practices of the investigators.
Participant milestones
| Measure |
Potassium Iodide
8 drops of Potassium Iodide in a glass of water, by mouth, daily for 7 days prior to operation.
Potassium Iodide: 8 drops of Potassium Iodide in a glass of water taken daily for 7 days prior to thyroidectomy. This is the current standard of care.
|
No Treatment
The experimental group receives no treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
15
|
|
Overall Study
COMPLETED
|
18
|
15
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Potassium Iodide
8 drops of Potassium Iodide in a glass of water, by mouth, daily for 7 days prior to operation.
Potassium Iodide: 8 drops of Potassium Iodide in a glass of water taken daily for 7 days prior to thyroidectomy. This is the current standard of care.
|
No Treatment
The experimental group receives no treatment.
|
|---|---|---|
|
Overall Study
Physician Decision
|
3
|
0
|
Baseline Characteristics
Impact of SSKI Pre-Treatment on Blood Loss in Thyroidectomy for Graves Disease
Baseline characteristics by cohort
| Measure |
Potassium Iodide
n=21 Participants
8 drops of Potassium Iodide in a glass of water, by mouth, daily for 7 days prior to operation.
Potassium Iodide: 8 drops of Potassium Iodide in a glass of water taken daily for 7 days prior to thyroidectomy. This is the current standard of care.
|
No Treatment
n=15 Participants
The experimental group receives no treatment.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.44 years
STANDARD_DEVIATION 12.27 • n=5 Participants
|
41.07 years
STANDARD_DEVIATION 10.62 • n=7 Participants
|
40.25 years
STANDARD_DEVIATION 11.44 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 162 minutesBlood loss in milliliters during surgery.
Outcome measures
| Measure |
Potassium Iodide
n=18 Participants
8 drops of Potassium Iodide in a glass of water, by mouth, daily for 7 days prior to operation.
Potassium Iodide: 8 drops of Potassium Iodide in a glass of water taken daily for 7 days prior to thyroidectomy. This is the current standard of care.
|
No Treatment
n=15 Participants
The experimental group receives no treatment.
|
|---|---|---|
|
Blood Loss During Surgery
|
61.67 mL
Standard Deviation 49.97
|
161.67 mL
Standard Deviation 134.62
|
Adverse Events
Potassium Iodide
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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