Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-03-13 @ 11:27 AM
Study NCT ID:
NCT02097602
Status:
COMPLETED
Last Update Posted:
2015-03-05
First Post:
2014-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation Between Reticulated Platelets and Major Adverse Cardiac and Cerebrovascular Events After Noncardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003643', 'term': 'Death'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D011655', 'term': 'Pulmonary Embolism'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004617', 'term': 'Embolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D013927', 'term': 'Thrombosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-04', 'studyFirstSubmitDate': '2014-03-17', 'studyFirstSubmitQcDate': '2014-03-24', 'lastUpdatePostDateStruct': {'date': '2015-03-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'major adverse cardiac and cerebrovascular events (MACCEs)', 'timeFrame': 'during the hospital stay, an expected average of 2 weeks', 'description': 'MACCEs are defined according to Sabaté et al. as: cardiac death, cerebrovascular death, nonfatal cardiac arrest, acute myocardial infarction, congestive heart failure, new cardiac arrhythmia, angina or stroke. Pulmonary embolism and deep vein thrombosis are further primary endpoints.'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'three months after discharge', 'description': 'mortality'}, {'measure': 'length of hospital and intensive care-stay', 'timeFrame': 'three months after discharge', 'description': 'length of hospital and intensive care-stay'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Reticulated platelets', 'noncardiac surgery', 'MACCEs', 'major adverse cardiac and cerebrovascular events', 'outcome', 'High-risk or intermediate-risk noncardiac surgery'], 'conditions': ['Cardiac Death', 'Congestive Heart Failure', 'Angina Pectoris', 'Stroke', 'Pulmonary Embolism', 'Deep Vein Thrombosis']}, 'referencesModule': {'references': [{'pmid': '12297121', 'type': 'BACKGROUND', 'citation': 'Nakamura T, Uchiyama S, Yamazaki M, Okubo K, Takakuwa Y, Iwata M. Flow cytometric analysis of reticulated platelets in patients with ischemic stroke. Thromb Res. 2002 May 15;106(4-5):171-7. doi: 10.1016/s0049-3848(02)00131-7.'}, {'pmid': '19132202', 'type': 'BACKGROUND', 'citation': 'Grove EL, Hvas AM, Kristensen SD. Immature platelets in patients with acute coronary syndromes. Thromb Haemost. 2009 Jan;101(1):151-6.'}, {'pmid': '23494003', 'type': 'BACKGROUND', 'citation': 'Cesari F, Marcucci R, Gori AM, Caporale R, Fanelli A, Casola G, Balzi D, Barchielli A, Valente S, Giglioli C, Gensini GF, Abbate R. Reticulated platelets predict cardiovascular death in acute coronary syndrome patients. Insights from the AMI-Florence 2 Study. Thromb Haemost. 2013 May;109(5):846-53. doi: 10.1160/TH12-09-0709. Epub 2013 Mar 14.'}, {'pmid': '21890661', 'type': 'BACKGROUND', 'citation': 'Sabate S, Mases A, Guilera N, Canet J, Castillo J, Orrego C, Sabate A, Fita G, Parramon F, Paniagua P, Rodriguez A, Sabate M; ANESCARDIOCAT Group. Incidence and predictors of major perioperative adverse cardiac and cerebrovascular events in non-cardiac surgery. Br J Anaesth. 2011 Dec;107(6):879-90. doi: 10.1093/bja/aer268. Epub 2011 Sep 2.'}, {'pmid': '36974887', 'type': 'DERIVED', 'citation': 'Anetsberger A, Bernlochner I, Jungwirth B, Blobner M, Meyer B, Kochs EF, Bongiovanni D, Schmid S, Langgartner C, Baumgart L, Gempt J. Association of immature platelets with perioperative complications in neurosurgery. Platelets. 2023 Dec;34(1):2185462. doi: 10.1080/09537104.2023.2185462.'}, {'pmid': '28796275', 'type': 'DERIVED', 'citation': 'Anetsberger A, Blobner M, Haller B, Schmid S, Umgelter K, Hager T, Langgartner C, Kochs EF, Laugwitz KL, Jungwirth B, Bernlochner I. Immature platelets as a novel biomarker for adverse cardiovascular events in patients after non-cardiac surgery. Thromb Haemost. 2017 Oct 5;117(10):1887-1895. doi: 10.1160/TH16-10-0804. Epub 2017 Aug 10.'}]}, 'descriptionModule': {'briefSummary': 'This is an observational study designed to monitor the course of the fraction of reticulated platelets and the correlation thereof to major adverse cardiac and cerebrovascular events after noncardiac surgery.', 'detailedDescription': 'Reticulated platelets (RP) are newly formed, immature platelets which in contrast to mature platelets have high granule content and a residual amount of mRNA. An increased mean platelet volume (MPV) and the fraction of RP have been shown to be correlated to cardiovascular events like myocardial infarction or cardiovascular death. However, there are no trials so far investigating how surgery impacts the fraction of RP and how this fraction correlates with the outcome after noncardiac surgery.\n\nPatients with an age above 18 years undergoing high-risk or intermediate-risk noncardiac surgery are to be included. The fraction of RP is to be investigated in routinely acquired blood samples preoperatively, postoperatively in the recovery room, as well as 24-72 hours after anaesthesia and surgery.\n\nA primary common endpoint are major adverse cardiac and cerebrovascular events (MACCEs), as well as deep vein thrombosis and pulmonary embolism. MACCEs are defined according to Sabaté et al. as: cardiac death, cerebrovascular death, nonfatal cardiac arrest, acute myocardial infarction, congestive heart failure, new cardiac arrhythmia, angina or stroke. Secondary endpoints are lengths of hospital stay and intensive care stay as well as mortality after 3 months. All participants are to be contacted by phone three months after discharge and their health situation is to be determined.\n\n1000 patients will be enrolled in a defined time frame of six months'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'High-risk or intermediate-risk surgical patients older than 18 years undergoing noncardiac surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* high-risk or intermediate-risk surgical patients undergoing noncardiac surgery\n* age ≥ 18 years\n* written informed consent\n\nExclusion Criteria:\n\n* low-risk surgery\n* age \\< 18 years'}, 'identificationModule': {'nctId': 'NCT02097602', 'briefTitle': 'Correlation Between Reticulated Platelets and Major Adverse Cardiac and Cerebrovascular Events After Noncardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Munich'}, 'officialTitle': 'Can Reticulated Platelets Predict the Outcome After Noncardiac Surgery?', 'orgStudyIdInfo': {'id': 'RePOS'}}, 'contactsLocationsModule': {'locations': [{'zip': '81675', 'city': 'Munich', 'country': 'Germany', 'facility': 'Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München, Ismaninger Str. 22', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'overallOfficials': [{'name': 'Bettina Jungwirth, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Klinikum rechts der Isar Technische Universität München'}, {'name': 'Aida Anetsberger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinikum rechts der Isar Technische Universität München'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technical University of Munich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}