Nctid:
NCT00001518
Payload:
{"FullStudy"=>{"Rank"=>472957, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"November 27, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000013927", "ConditionMeshTerm"=>"Thrombosis"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000016769", "ConditionAncestorTerm"=>"Embolism and Thrombosis"}, {"ConditionAncestorId"=>"D000014652", "ConditionAncestorTerm"=>"Vascular Diseases"}, {"ConditionAncestorId"=>"D000002318", "ConditionAncestorTerm"=>"Cardiovascular Diseases"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M16376", "ConditionBrowseLeafName"=>"Thrombosis", "ConditionBrowseLeafAsFound"=>"Thrombosis", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M8300", "ConditionBrowseLeafName"=>"Flushing", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M7474", "ConditionBrowseLeafName"=>"Embolism", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M18818", "ConditionBrowseLeafName"=>"Embolism and Thrombosis", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17090", "ConditionBrowseLeafName"=>"Vascular Diseases", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Heart and Blood Diseases", "ConditionBrowseBranchAbbrev"=>"BC14"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Symptoms and General Pathology", "ConditionBrowseBranchAbbrev"=>"BC23"}]}}, "InterventionBrowseModule"=>{"InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M21550", "InterventionBrowseLeafName"=>"Pharmaceutical Solutions", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Pharmaceutical Solutions", "InterventionBrowseBranchAbbrev"=>"PhSol"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"StudyType"=>"Observational", "EnrollmentInfo"=>{"EnrollmentCount"=>"132"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"January 1996"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"December 1999", "CompletionDateStruct"=>{"CompletionDate"=>"November 2000"}, "LastUpdateSubmitDate"=>"March 3, 2008", "StudyFirstSubmitDate"=>"November 3, 1999", "StudyFirstSubmitQCDate"=>"December 9, 2002", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"March 4, 2008", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"December 10, 2002", "StudyFirstPostDateType"=>"Estimate"}}, "OversightModule"=>{}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Groshong Catheter", "Heparinized Flush Solution", "Intraluminal Clot", "Urokinase", "Venous Access Device", "Withdrawal Occlusion"]}, "ConditionList"=>{"Condition"=>["Catheters, Indwelling", "Thrombosis"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"8899756", "ReferenceType"=>"background", "ReferenceCitation"=>"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."}]}}, "DescriptionModule"=>{"BriefSummary"=>"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.", "DetailedDescription"=>"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."}, "EligibilityModule"=>{"Gender"=>"All", "StdAgeList"=>{"StdAge"=>["Child", "Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"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.\n\nNo subjects with a history of allergy to heparin.\n\nNo abnormal PT or PTT.\n\nNo subjects on anticoagulant therapy.\n\nNo history of heparin induced thrombocytopenia."}, "IdentificationModule"=>{"NCTId"=>"NCT00001518", "BriefTitle"=>"A Randomized Evaluation of the Effect of Routine Normal Saline Flush Versus Heparinized Saline Solution in Groshong and Groshong PICC Catheters", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institutes of Health Clinical Center (CC)"}, "OfficialTitle"=>"A Randomized Evaluation of the Effect of Routine Normal Saline Flush Versus Heparinized Saline Solution in Groshong and Groshong PICC Catheters", "OrgStudyIdInfo"=>{"OrgStudyId"=>"960053"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"96-CC-0053"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"20892", "LocationCity"=>"Bethesda", "LocationState"=>"Maryland", "LocationCountry"=>"United States", "LocationFacility"=>"Warren G. Magnuson Clinical Center (CC)"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Institutes of Health Clinical Center (CC)", "LeadSponsorClass"=>"NIH"}}}}}}
