Impact of SSKI Pre-Treatment on Blood Loss in Thyroidectomy for Graves Disease

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Giles Whalen, University of Massachusetts, Worcester

ClinicalTrials.gov Identifier:

NCT00946296

First received: July 22, 2009

Last updated: May 22, 2013

Last verified: May 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	July 22, 2009
Last Updated Date	May 22, 2013
Start Date ^ICMJE	April 2005
Estimated Primary Completion Date	April 2015 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 23, 2009)	Blood Loss during surgery [ Time Frame: Post Operatively ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00946296 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Impact of SSKI Pre-Treatment on Blood Loss in Thyroidectomy for Graves Disease
Official Title ^ICMJE	Impact of SSKI Pre-Treatment on Blood Loss in Thyroidectomy for Graves Disease
Brief Summary	The purpose of this study is to determine whether a brief course of SSKI (iodine) administered preoperatively provides any benefit in the surgical management of patients undergoing thyroidectomy as definitive management of their Graves Disease.
Detailed Description	Historically Potassium Iodide was given to patients for 1 week prior to thyroidectomy. This common practice was used to decrease thyroid function and prevent thyroid storm during the thyroidectomy. However, in modern practice, nearly all patients presenting for surgical management have been made euthyroid through the use of medications such as propylthiouracil. Despite this potassium iodine continues to be administered with the presumption that it decreases the friability of the gland making surgery easier, with less blood loss. The outcomes to be measured in this surgery are operative time, operative complications and blood loss.
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Graves Disease Hyperthyroidism
Intervention ^ICMJE	Drug: Potassium Iodine 8 drops of Potassium Iodine in a glass of water taken daily for 7 days prior to thyroidectomy. This is the current standard of care. The Experimental Group is the group which receives no Potassium Iodine.
Study Arm (s)	Active Comparator: 1 Receives Potassium Iodine which is the current Standard of Care Intervention: Drug: Potassium Iodine Experimental: No Treatment Intervention: Drug: Potassium Iodine
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	35
Estimated Completion Date	April 2015
Estimated Primary Completion Date	April 2015 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: 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 Exclusion Criteria: 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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00946296
Other Study ID Numbers ^ICMJE	11597
Has Data Monitoring Committee	No
Responsible Party	Giles Whalen, University of Massachusetts, Worcester
Study Sponsor ^ICMJE	University of Massachusetts, Worcester
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Massachusetts, Worcester
Verification Date	May 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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