{
  "FullStudy":{
    "Rank":218108,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01512628",
          "OrgStudyIdInfo":{
            "OrgStudyId":"B1111-140-010"
          },
          "Organization":{
            "OrgFullName":"Seoul National University Bundang Hospital",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Rotational Thromboelstometry (ROTEM) change_colloid_total Hip Replacement Arthroplasty",
          "OfficialTitle":"Hemostatic Changes After Colloid Fluid Administration During Total Hip Replacement Arthroplasty"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2014",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"December 2013",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"December 2013",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 9, 2012",
          "StudyFirstSubmitQCDate":"January 14, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 19, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 26, 2014",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 28, 2014",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Hyo-Seok Na",
            "ResponsiblePartyInvestigatorTitle":"Assistant professor",
            "ResponsiblePartyInvestigatorAffiliation":"Seoul National University Bundang Hospital"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Seoul National University Bundang Hospital",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The investigators administered different kinds of colloids before transfusion of red blood cell to patient undergoing total hip replacement arthroplasty. The investigators will compare the differences of changes in rotational thromboelastometry (ROTEM) data among them."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Avascular Necrosis of Hip",
              "Total Hip Replacement Arthroplasty"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"75",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"PENTA group",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"Pentaspan is administered as a colloid.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Pentaspan, voluven, volulyte"
                  ]
                }
              },{
                "ArmGroupLabel":"voluVEN group",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"Voluven is administered as a colloid.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Pentaspan, voluven, volulyte"
                  ]
                }
              },{
                "ArmGroupLabel":"voluLYTE group",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"Volulyte is administered as a colloid.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Pentaspan, voluven, volulyte"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"Pentaspan, voluven, volulyte",
                "InterventionDescription":"Different colloids are administered during operation for replacement of blood loss before the transfusion of blood.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "PENTA group",
                    "voluLYTE group",
                    "voluVEN group"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"INTEM parameters change from preoperative values at post-operation",
                "PrimaryOutcomeDescription":"clotting time (sec), clot firmness time (sec), alpah angle, maximum clot firmness (mm)",
                "PrimaryOutcomeTimeFrame":"30 minutes before operation and 30 minutes after operation"
              },{
                "PrimaryOutcomeMeasure":"EXTEM parameters change from preoperative values at post-operation",
                "PrimaryOutcomeDescription":"clotting time (sec), clot firmness time (sec), alpah angle, maximum clot firmness (mm)",
                "PrimaryOutcomeTimeFrame":"30 minutes before and 30 minutes after operation."
              },{
                "PrimaryOutcomeMeasure":"FIBTEM parameters change from preoperative values at post-operation",
                "PrimaryOutcomeDescription":"maximum clot firmness (mm)",
                "PrimaryOutcomeTimeFrame":"30 min before and 30 min after operation"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Infused total fluid volume",
                "SecondaryOutcomeDescription":"crystalloid and colloid",
                "SecondaryOutcomeTimeFrame":"Participants will be followed for the duration of THRA operation in operating room, an expected average tiem of 3 hours"
              },{
                "SecondaryOutcomeMeasure":"Hemoglobin",
                "SecondaryOutcomeTimeFrame":"30 minutes before operation and 30 minutes after operation"
              },{
                "SecondaryOutcomeMeasure":"postoperative blood loss",
                "SecondaryOutcomeTimeFrame":"postoperative 1 day and 2 day"
              },{
                "SecondaryOutcomeMeasure":"Hematocrit",
                "SecondaryOutcomeTimeFrame":"30 minutes before operation and 30 minutes after operation"
              },{
                "SecondaryOutcomeMeasure":"Platelet",
                "SecondaryOutcomeTimeFrame":"30 minutes before operation and 30 minutes after operation"
              },{
                "SecondaryOutcomeMeasure":"Prothrombin Time-Internatiolnal Normalized Ratio",
                "SecondaryOutcomeTimeFrame":"30 minutes before operation and 30 minutes after operation"
              },{
                "SecondaryOutcomeMeasure":"Activated Partial Thrombin Time",
                "SecondaryOutcomeTimeFrame":"30 minutes before operation and 30 minutes after operation"
              },{
                "SecondaryOutcomeMeasure":"electrolytes",
                "SecondaryOutcomeTimeFrame":"30 minutes before operation and 30 minutes after operation"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nPatients diagnosed as avascular necrosis of hip and undergoing total hip replacement arthroplasty\n\nExclusion Criteria:\n\nhematologic disease\nanticoagulant medication\npreoperative hemoglobin < 10 g/dl\nrenal disease\npulmonary disease (pulmonary edema, effusion)\ncardiovascular disease (coronary heart disease, congestive heart failure)",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"20 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Seoul National University Bundang Hospital",
                "LocationCity":"Seongnam",
                "LocationState":"Gyounggi",
                "LocationZip":"463-707",
                "LocationCountry":"Korea, Republic of"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000006895",
                "InterventionMeshTerm":"Hydroxyethyl Starch Derivatives"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000010952",
                "InterventionAncestorTerm":"Plasma Substitutes"
              },{
                "InterventionAncestorId":"D000001802",
                "InterventionAncestorTerm":"Blood Substitutes"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M8530",
                "InterventionBrowseLeafName":"Hydroxyethyl Starch Derivatives",
                "InterventionBrowseLeafAsFound":"Pentaspan",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M12425",
                "InterventionBrowseLeafName":"Plasma Substitutes",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M3665",
                "InterventionBrowseLeafName":"Blood Substitutes",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"BlSubst",
                "InterventionBrowseBranchName":"Blood Substitutes"
              },{
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              }
            ]
          }
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000009336",
                "ConditionMeshTerm":"Necrosis"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000010335",
                "ConditionAncestorTerm":"Pathologic Processes"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M10867",
                "ConditionBrowseLeafName":"Necrosis",
                "ConditionBrowseLeafAsFound":"Necrosis",
                "ConditionBrowseLeafRelevance":"high"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}