Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-25 @ 7:07 PM
Study NCT ID:
NCT00400504
Status:
UNKNOWN
Last Update Posted:
2006-11-17
First Post:
2006-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hypercoagulability and Thromboembolic Risk in Patients With Malignant Disease, Evaluated by Thrombelastograph (TEG®)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D019851', 'term': 'Thrombophilia'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'DEFINED_POPULATION'}, 'enrollmentInfo': {'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-11', 'lastUpdateSubmitDate': '2006-11-16', 'studyFirstSubmitDate': '2006-11-16', 'studyFirstSubmitQcDate': '2006-11-16', 'lastUpdatePostDateStruct': {'date': '2006-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-17', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Thrombelastograph', 'Cancer', 'Thromboembolism', 'Hypercoagulable'], 'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'Patients with malignancies are at high risk of developing a thromboembolic complication and their treatment with chemo- and or radiation therapy further enhances this risk.\n\nConventional haemostatic tests are not suitable as a screening tool of a hypercoagulable state. A hypercoagulable profile identified with the whole blood Thrombelastograph (TEG) Analyzer parameter maximal amplitude (MA) is reported to correlate with thrombotic events in patients undergoing major non-cardial surgery and recurrent ischemic events in patients undergoing percutaneous coronary intervention.\n\nIn this study we investigate the correlation between TEG measurements and thromboembolic events in patients with newly diagnosed malignancies.\n\nThe hypotheses of this study are:\n\n1. Patients with malignancies and hypercoagulability, defined as a TEG MA\\>69 mm and /or R\\<4 min is at increased risk of developing thromboembolic complications as compared to those with a MA\\<69 mm and/or a R\\>4 min.\n2. Hypercoagulability and hence TEG R and MA values are affected by the treatment instituted in these patients (chemo and radiation therapy) rendering the patients more hypercoagulable and hence at increased risk of developing thrombotic complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of cancer\n\nExclusion Criteria:\n\n* Mamma cancer'}, 'identificationModule': {'nctId': 'NCT00400504', 'briefTitle': 'Hypercoagulability and Thromboembolic Risk in Patients With Malignant Disease, Evaluated by Thrombelastograph (TEG®)', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Hypercoagulability and Thromboembolic Risk in Patients With Malignant Disease, Evaluated by Thrombelastograph (TEG®)', 'orgStudyIdInfo': {'id': 'TEG-Onkologi'}}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-2100', 'city': 'Copenhagen', 'state': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Louise Bochsen, MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Louise Bochsen, MSc', 'role': 'CONTACT', 'email': 'louise.bochsen@rh.hosp.dk', 'phone': '+4535452033'}], 'overallOfficials': [{'name': 'Pär I Johansson, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Rigshospitalet, Denmark'}, {'name': 'Gedske Daugaard, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}}}}