Impact of SSKI Pre-Treatment on Blood Loss in Thyroidectomy for Graves Disease
1 other identifier
interventional
36
1 country
1
Brief Summary
The purpose of this study is to determine whether a brief course of SSKI (saturated solution of potassium iodide) administered preoperatively provides any benefit in the surgical management of patients undergoing thyroidectomy as definitive management of their Graves Disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Apr 2005
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
July 22, 2009
CompletedFirst Posted
Study publicly available on registry
July 24, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedResults Posted
Study results publicly available
December 15, 2015
CompletedDecember 15, 2015
November 1, 2015
8 years
July 22, 2009
October 9, 2015
November 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blood Loss During Surgery
Blood loss in milliliters during surgery.
up to 162 minutes
Study Arms (2)
Potassium Iodide
ACTIVE COMPARATOR8 drops of Potassium Iodide in a glass of water, by mouth, daily for 7 days prior to operation.
No Treatment
NO INTERVENTIONThe experimental group receives no treatment.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Adult patients with a clinical diagnosis of Graves Disease
- Patients who have selected surgical resection as treatment of their Graves Disease
- Prior use of anti thyroid medication so that patient is clinically and biochemically euthyroid
You may not qualify if:
- Patients deemed unfit for surgery by operating surgeon or anesthesist
- Patients who are clinically hyperthyroid or have T3 or T4 levels 2X the upper limit of normal
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UMASS Memorial Health Care
Worcester, Massachusetts, 01655, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Difficulty in enrolling subjects related to national shortages of potassium iodine which limited drug availability and contributed to delayed accrual as did decreased eligible patients and waning interest over time.
Results Point of Contact
- Title
- Dr. Giles Whalen
- Organization
- UMass Medical School
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2009
First Posted
July 24, 2009
Study Start
April 1, 2005
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
December 15, 2015
Results First Posted
December 15, 2015
Record last verified: 2015-11