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A Randomized Evaluation of the Effect of Routine Normal Saline Flush Versus Heparinized Saline Solution in Groshong and Groshong PICC Catheters

Primary Purpose

Catheters, Indwelling, Thrombosis

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institutes of Health Clinical Center (CC)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Catheters, Indwelling focused on measuring Groshong Catheter, Heparinized Flush Solution, Intraluminal Clot, Urokinase, Venous Access Device, Withdrawal Occlusion

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Warren G. Magnuson Clinical Center (CC)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Institutes of Health Clinical Center (CC)
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1. Study Identification

Unique Protocol Identification Number
NCT00001518
Brief Title
A Randomized Evaluation of the Effect of Routine Normal Saline Flush Versus Heparinized Saline Solution in Groshong and Groshong PICC Catheters
Official Title
A Randomized Evaluation of the Effect of Routine Normal Saline Flush Versus Heparinized Saline Solution in Groshong and Groshong PICC Catheters
Study Type
Observational

2. Study Status

Record Verification Date
December 1999
Overall Recruitment Status
Completed
Study Start Date
January 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2000 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institutes of Health Clinical Center (CC)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Catheters, Indwelling, Thrombosis
Keywords
Groshong Catheter, Heparinized Flush Solution, Intraluminal Clot, Urokinase, Venous Access Device, Withdrawal Occlusion

7. Study Design

Enrollment
132 (false)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Warren G. Magnuson Clinical Center (CC)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8899756
Citation
Mayo DJ, Horne MK 3rd, Summers BL, Pearson DC, Helsabeck CB. The effects of heparin flush on patency of the Groshong catheter: a pilot study. Oncol Nurs Forum. 1996 Oct;23(9):1401-5.
Results Reference
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A Randomized Evaluation of the Effect of Routine Normal Saline Flush Versus Heparinized Saline Solution in Groshong and Groshong PICC Catheters

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