- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001518
A Randomized Evaluation of the Effect of Routine Normal Saline Flush Versus Heparinized Saline Solution in Groshong and Groshong PICC Catheters
March 3, 2008 updated by: National Institutes of Health Clinical Center (CC)
The Groshong and Groshong PICC catheters are popular venous access devices because they are maintained with only weekly saline flushes.
In a recent study, however, we found an apparent decrease in the rate of withdrawal occlusion in Groshong catheters flushed weekly with heparinized saline.
However, a randomized trial is necessary to confirm this impression.
In the current study as many as 66 patients will be randomized to each of two treatment arms.
The Groshong catheters of one group will be flushed with saline only and the other group with heparinized saline.
A comparison will be made between the frequency with which urokinase is used in the two groups to treat withdrawal occlusion during the first three months of catheterization.
Groshong catheters using saline flushes will be compared to Groshong catheters using heparinized saline flushes and Groshong PICC catheters using saline flushes will be compared to Groshong PICC catheters using heparinized saline flushes.
Data will be analyzed using Fisher's exact test.
Study Overview
Status
Completed
Conditions
Detailed Description
The Groshong and Groshong PICC catheters are popular venous access devices because they are maintained with only weekly saline flushes.
In a recent study, however, we found an apparent decrease in the rate of withdrawal occlusion in Groshong catheters flushed weekly with heparinized saline.
However, a randomized trial is necessary to confirm this impression.
In the current study as many as 66 patients will be randomized to each of two treatment arms.
The Groshong catheters of one group will be flushed with saline only and the other group with heparinized saline.
A comparison will be made between the frequency with which urokinase is used in the two groups to treat withdrawal occlusion during the first three months of catheterization.
Groshong catheters using saline flushes will be compared to Groshong catheters using heparinized saline flushes and Groshong PICC catheters using saline flushes will be compared to Groshong PICC catheters using heparinized saline flushes.
Data will be analyzed using Fisher's exact test.
Study Type
Observational
Enrollment
132
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- Warren G. Magnuson Clinical Center (CC)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Adult subjects enrolled in approved protocols of the NCI in the CC or under treatment at the National Naval Medical Center who are planned to have Groshong Catheters used as part of their cancer treatment.
No subjects with a history of allergy to heparin.
No abnormal PT or PTT.
No subjects on anticoagulant therapy.
No history of heparin induced thrombocytopenia.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 1996
Study Completion
November 1, 2000
Study Registration Dates
First Submitted
November 3, 1999
First Submitted That Met QC Criteria
December 9, 2002
First Posted (ESTIMATE)
December 10, 2002
Study Record Updates
Last Update Posted (ESTIMATE)
March 4, 2008
Last Update Submitted That Met QC Criteria
March 3, 2008
Last Verified
December 1, 1999
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 960053
- 96-CC-0053
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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