Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-03-11 @ 4:30 PM
Study NCT ID:
NCT02009033
Status:
COMPLETED
Last Update Posted:
2013-12-11
First Post:
2011-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Colloid Versus Crystalloid on Coagulation in Elective Urological Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020141', 'term': 'Hemostatic Disorders'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077325', 'term': "Ringer's Lactate"}, {'id': 'D006895', 'term': 'Hydroxyethyl Starch Derivatives'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D013213', 'term': 'Starch'}, {'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D011134', 'term': 'Polysaccharides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-06', 'studyFirstSubmitDate': '2011-07-18', 'studyFirstSubmitQcDate': '2013-12-06', 'lastUpdatePostDateStruct': {'date': '2013-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimate coagulation on basis of bloodsamples', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Estimate coagulation by bloodloss and need for transfusion', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Disorders of Coagulation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effect of thin fluid with starch versus thin fluid without starch on coagulation in elective surgery when the patient is normovolæmic during operation.', 'detailedDescription': 'The primary goal is to register coagulation on basis of blood samples inclusive thromboelastography results.\n\nThe secondary goal is to register blood loss and use of blood products during operation.\n\nThe trial concerns 40 patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient older than 18 years.\n* Indication for elective surgery with removal of the urine bladder.\n* Patient without anticoagulative, acethylsalisylsyre or NSAID medicine during the last 5 days,if using.\n\nExclusion Criteria:\n\n* Cerebral haemorrhage\n* Renal insufficiency demanding dialysis\n* Manifest cardiac and hepatic insufficiency\n* Disturbance in coagulation\n* Hypernatriæmi\n* Hyperchloræmi\n* Pregnant or nursing\n* Allergic to hydroxyethylstarch\n* Participating in another trial-if interferring the present trial\n* Incapable of managing his own affairs.'}, 'identificationModule': {'nctId': 'NCT02009033', 'briefTitle': 'Effect of Colloid Versus Crystalloid on Coagulation in Elective Urological Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Effect of Colloid Versus Crystalloid on Coagulation in Elective Urological Surgery. A Randomised Clinical Study', 'orgStudyIdInfo': {'id': 'H-2-2011-063'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': "Ringer's lactate", 'description': 'Fluid therapy during operation', 'interventionNames': ['Drug: Lactated Ringer', 'Drug: Hydroxyethylstarch']}], 'interventions': [{'name': 'Lactated Ringer', 'type': 'DRUG', 'description': 'When normovolæmic status of the patient is secured, 35 ml/kg of the allocated fluid is infused during the operation (estimated time for this type of operation is 180 minutes), however max. 3500 ml.Lactated Ringer is the interventional medication.', 'armGroupLabels': ["Ringer's lactate"]}, {'name': 'Hydroxyethylstarch', 'type': 'DRUG', 'armGroupLabels': ["Ringer's lactate"]}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Niels Henry Secher, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Rigshospitalet , Dept. 2042, 2100 Copenhagen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'K. C. Rasmussen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'K. C. Rasmussen', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}