Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2025-12-28 @ 3:00 PM
Study NCT ID:
NCT06957366
Status:
RECRUITING
Last Update Posted:
2025-05-09
First Post:
2025-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perioperative Anticoagulant Use for Surgery Evaluation -2 (PAUSE-2) Study Patients Receiving a Direct Oral Anticoagulant (DOACs-Dabigatran, Rivaroxaban, Apixaban or Edoxaban) and Needing Elective High-Bleed-Risk Surgery or an Invasive Procedure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients taking Apixaban, Dabigatran, Rivaroxaban or Edoxaban will be randomly assigned to follow 1) PAUSE or 2) ASRA perioperative DOAC management.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 920}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-06', 'studyFirstSubmitDate': '2025-04-25', 'studyFirstSubmitQcDate': '2025-04-25', 'lastUpdatePostDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients randomized to each study arm with a residual pre-operative DOAC level < 30 ng/mL', 'timeFrame': 'Day 1', 'description': 'The primary outcome in PAUSE-2 will be the proportion of patients with a residual pre-operative DOAC level \\< 30 ng/mL. Pre-operative DOAC levels will be measured using calibrated anti-Xa assays for direct factor Xa inhibitors (apixaban, edoxaban, rivaroxaban) and will be measured using a dilute thrombin time assay for dabigatran-treated patients.'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients with a residual pre-operative DOAC level < 50 ng/mL.', 'timeFrame': 'Day 1', 'description': 'Pre-operative DOAC levels will be measured using calibrated anti-Xa assays for direct factor Xa inhibitors (apixaban, edoxaban, rivaroxaban) and will be measured using a dilute thrombin time assay for dabigatran-treated patients.'}, {'measure': 'Clinically relevant nonmajor bleeding', 'timeFrame': 'Day 28', 'description': 'Any overt bleeding not satisfying the criteria for major bleeding but considered clinically important with one or more of the following criteria met: - Requires minimal medical intervention (blood in urine or stool that is ongoing and requires a sigmoidoscopy, cystoscopy, CBI etc.) by a healthcare professional - Lead to hospitalization or increased level of care - Prompted a face-to-face (ie. not telephone, electronic) evaluation by a physician (this does not include visits prompted by pain, infection, other symptoms etc.)'}, {'measure': 'Arterial thromboembolic Events (ATE)', 'timeFrame': 'Day 28', 'description': 'Any of the following: stroke, systemic embolism, and/or transient ischemic attack. - Ischemic stroke: any new focal neurologic deficit that persists for \\>24 hours or any new focal neurologic deficit of any duration, that occurs with evidence of acute infarction on computed tomography (CT) or magnetic resonance imaging (MRI) of the brain. - Systemic embolism: symptomatic embolism to upper or lower extremity or abdominal organ, confirmed intra-operatively or by objective imaging (e.g., CT angiography). - Transient ischemic attack: symptomatic focal neurologic deficit (lasting typically \\<1 hour), that occurs with no evidence of acute infarction on CT/MRI of brain.'}, {'measure': 'Major bleeding', 'timeFrame': 'Day 28', 'description': '≥1 of the criteria below: - bleeding that is fatal or is symptomatic and retroperitoneal, intracranial, intraspinal, intraocular, pericardial, intramuscular with compartment syndrome, or intra-articular - non-surgical bleeding causing a drop in hemoglobin ≥20 g/L (1.24 mmol/L) or leading to transfusion ≥2 units whole blood or red cells within 48 hours of the bleed - surgical bleed that leads to intervention (e.g., re-operation) or has one of: (i) interferes with mobilization; (ii) leads to delayed wound healing; or (iii) leads to deep wound infection - surgical site bleeding that is unexpected and prolonged and/or sufficiently large to cause hemodynamic instability associated with: (i) drop in hemoglobin ≥20 g/L (1.24 mmol/L); or (ii) transfusion of ≥2 units whole blood or red cells within 48 hours of the bleed.'}, {'measure': 'Minor bleeding', 'timeFrame': 'Day 28', 'description': 'Any overt bleeding not satisfying the criteria for major and clinically relevant non-major bleeding.'}, {'measure': 'Venous thromboembolic Events (VTE)', 'timeFrame': 'Day 28', 'description': 'Any of the following: symptomatic deep vein thrombosis and/or pulmonary embolism, confirmed by objective imaging studies (e.g., ultrasound, CT pulmonary angiogram).'}, {'measure': 'Myocardial infarction', 'timeFrame': 'Day 28'}, {'measure': 'All-cause death', 'timeFrame': 'Day 28', 'description': 'Death due to any cause.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anticoagulation', 'atrial Fibrillation', 'Surgery', 'Oral Anticoagulant', 'Blood thinner', 'DOAC', 'VTE', 'Interruption', 'PAUSE'], 'conditions': ['Atrial Fibrillation (AF)', 'VTE']}, 'referencesModule': {'references': [{'pmid': '37497426', 'type': 'BACKGROUND', 'citation': 'Shaw JR, Unachukwu U, Cyr J, Siegal DM, Castellucci LA, Dreden PV, Dowlatshahi D, Buyukdere H, Ramsay T, Carrier M. Effect of PCC on Thrombin Generation among Patients on Factor Xa Inhibitors with Major Bleeding or Needing Urgent Surgery (GAUGE): Design and Rationale. TH Open. 2023 Jul 25;7(3):e229-e240. doi: 10.1055/s-0043-1771300. eCollection 2023 Jul.'}, {'pmid': '36696204', 'type': 'BACKGROUND', 'citation': 'Shaw JR, Castellucci LA, Siegal D, Carrier M. DOAC-associated bleeding, hemostatic strategies, and thrombin generation assays - a review of the literature. J Thromb Haemost. 2023 Mar;21(3):433-452. doi: 10.1016/j.jtha.2022.11.029. Epub 2022 Dec 22.'}, {'pmid': '31705521', 'type': 'BACKGROUND', 'citation': 'Harenberg J, Beyer-Westendorf J, Crowther M, Douxfils J, Elalamy I, Verhamme P, Bauersachs R, Hetjens S, Weiss C; Working Group Members. Accuracy of a Rapid Diagnostic Test for the Presence of Direct Oral Factor Xa or Thrombin Inhibitors in Urine-A Multicenter Trial. Thromb Haemost. 2020 Jan;120(1):132-140. doi: 10.1055/s-0039-1700545. Epub 2019 Nov 8.'}, {'pmid': '30985986', 'type': 'BACKGROUND', 'citation': 'Kim PY, Di Giuseppantonio LR, Wu C, Douketis JD, Gross PL. An assay to measure levels of factor Xa inhibitors in blood and plasma. J Thromb Haemost. 2019 Jul;17(7):1153-1159. doi: 10.1111/jth.14451. Epub 2019 May 10.'}, {'pmid': '36305802', 'type': 'BACKGROUND', 'citation': 'Mitrovic D, van Elp M, Veeger N, Lameijer H, Meijer K, van Roon E. Protocols for perioperative management of direct oral anticoagulants in hospitals: opportunities for improvement. Curr Med Res Opin. 2023 Jan;39(1):13-18. doi: 10.1080/03007995.2022.2141962. Epub 2022 Nov 12.'}, {'pmid': '27386777', 'type': 'BACKGROUND', 'citation': 'Flaker GC, Theriot P, Binder LG, Dobesh PP, Cuker A, Doherty JU. Management of Periprocedural Anticoagulation: A Survey of Contemporary Practice. 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Epub 2013 Jul 4.'}, {'pmid': '36017553', 'type': 'BACKGROUND', 'citation': 'Halvorsen S, Mehilli J, Cassese S, Hall TS, Abdelhamid M, Barbato E, De Hert S, de Laval I, Geisler T, Hinterbuchner L, Ibanez B, Lenarczyk R, Mansmann UR, McGreavy P, Mueller C, Muneretto C, Niessner A, Potpara TS, Ristic A, Sade LE, Schirmer H, Schupke S, Sillesen H, Skulstad H, Torracca L, Tutarel O, Van Der Meer P, Wojakowski W, Zacharowski K; ESC Scientific Document Group. 2022 ESC Guidelines on cardiovascular assessment and management of patients undergoing non-cardiac surgery. Eur Heart J. 2022 Oct 14;43(39):3826-3924. doi: 10.1093/eurheartj/ehac270. No abstract available.'}, {'pmid': '37037035', 'type': 'BACKGROUND', 'citation': 'Parks AL, Fang MC. Periprocedural Anticoagulation. Ann Intern Med. 2023 Apr;176(4):ITC49-ITC64. doi: 10.7326/AITC202304180. Epub 2023 Apr 11.'}, {'pmid': '25899949', 'type': 'BACKGROUND', 'citation': 'Narouze S, Benzon HT, Provenzano DA, Buvanendran A, De Andres J, Deer TR, Rauck R, Huntoon MA. Interventional spine and pain procedures in patients on antiplatelet and anticoagulant medications: guidelines from the American Society of Regional Anesthesia and Pain Medicine, the European Society of Regional Anaesthesia and Pain Therapy, the American Academy of Pain Medicine, the International Neuromodulation Society, the North American Neuromodulation Society, and the World Institute of Pain. Reg Anesth Pain Med. 2015 May-Jun;40(3):182-212. doi: 10.1097/AAP.0000000000000223.'}, {'pmid': '29278603', 'type': 'BACKGROUND', 'citation': 'Narouze S, Benzon HT, Provenzano D, Buvanendran A, De Andres J, Deer T, Rauck R, Huntoon MA. Interventional Spine and Pain Procedures in Patients on Antiplatelet and Anticoagulant Medications (Second Edition): Guidelines From the American Society of Regional Anesthesia and Pain Medicine, the European Society of Regional Anaesthesia and Pain Therapy, the American Academy of Pain Medicine, the International Neuromodulation Society, the North American Neuromodulation Society, and the World Institute of Pain. Reg Anesth Pain Med. 2018 Apr;43(3):225-262. doi: 10.1097/AAP.0000000000000700.'}, {'pmid': '35964704', 'type': 'BACKGROUND', 'citation': 'Douketis JD, Spyropoulos AC, Murad MH, Arcelus JI, Dager WE, Dunn AS, Fargo RA, Levy JH, Samama CM, Shah SH, Sherwood MW, Tafur AJ, Tang LV, Moores LK. Perioperative Management of Antithrombotic Therapy: An American College of Chest Physicians Clinical Practice Guideline. Chest. 2022 Nov;162(5):e207-e243. doi: 10.1016/j.chest.2022.07.025. Epub 2022 Aug 11.'}]}, 'descriptionModule': {'briefSummary': 'PAUSE 2 study is a prospective, open-label, blinded-endpoint non-inferiority RCT of PAUSE vs. ASRA management in DOAC treated high risk patients with AF/VTE who need elective high bleed risk surgery/procedure and/or any procedure involving neuraxial anesthesia. The purpose of the PAUSE 2 study is to show that PAUSE management will be as safe (i.e., non-inferior) as ASRA management, with 95% of patients having low/undetectable pre-operative DOAC levels \\<30 ng/mL in each group., at the time of surgery/neuraxial.', 'detailedDescription': "As use of direct oral anticoagulants (DOACs) continues to increase so too will the need to manage such patients who require a surgery/procedure. Perioperative DOAC management is established and guideline supported in patients who need a low/moderate-bleed-risk surgery/procedure (e.g., hernia repair, colonoscopy), but there is uncertainty about managing high-risk patients who need a high-bleed-risk surgery (e.g., orthopedic, cardiac) or any neuraxial (i.e., spinal, epidural) anesthesia/procedure. The management of patients who are taking a DOAC (apixaban, dabigatran, edoxaban, rivaroxaban) and need a surgery/procedure is common, and will increase due to an ageing population and an associated increase in DOAC use. PAUSE-2 is applicable to approximately 96K patients/year in Canada, based on 1.6M prevalent patients with AF or VTE, of whom approximately 90% are taking a DOAC. Of these about 20% (approximately 288K) need perioperative management each year and approximately 1 in 3 (approximately 96K) are considered high-risk patients who need a high-bleed-risk surgery or neuraxial procedure. Perioperative DOAC management is of interest to a wide array of clinicians, including medical, surgical and anesthesia specialties, nurse practitioners, and pharmacists. In support of this statement, the Up-to-Date chapter on Perioperative Anticoagulation is in the top 0.6% (126th of 20,425) of all viewed chapters. However, guidelines provide weak recommendations on perioperative DOAC management in high-bleed-risk patients due to a lack of high-quality data.\n\nThere are two competing strategies for DOAC-treated patients who need a high-bleed-risk surgery/neuraxial:\n\n1. PAUSE management is simple and easy to apply as patients having a high-bleed-risk surgery/neuraxial procedure interrupt DOACs for 2 days before and 2 days after surgery without heparin bridging or DOAC level testing. This approach is based on the Perioperative Anticoagulant Use for Surgery Evaluation (PAUSE) study of 3,007-patients with atrial fibrillation (AF) who had elective surgery/procedure.\n2. ASRA management is more complex, requiring 72-120 hours DOAC interruption and, in selected patients, pre-operative heparin bridging and DOAC level testing. This management is based on recommendations from the American Society of Regional Anesthesia (ASRA) Guidelines, developed in 2015 and updated in 2018. ASRA's approach is very cautious so as to ensure no residual DOAC level at the time of a high-bleed-risk surgery/neuraxial procedure, using longer pre-operative DOAC interruption intervals.\n\nClinicians are divided on whether to use PAUSE or ASRA management for perioperative DOAC management in high-bleed-risk patients: Anesthetists strongly favor ASRA, as they consider it safer, in accordance with anesthesia society guidelines, and more prudent medico-legally than PAUSE. On the other hand, internists strongly favor PAUSE, which they consider more evidence-based than ASRA.\n\nAs shown in the table below, ASRA management is more complex (variable DOAC interruption) and harder to implement (DOAC testing, heparin bridging) than PAUSE (standard DOAC interruption, no DOAC testing/bridging). Though well-intentioned, ASRA management may not optimize patient safety and, indeed, may hinder adoption of standardized perioperative DOAC management."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults, age 18 years of age or greater, with AF/flutter (permanent, persistent or paroxysmal) or VTE (leg deep vein thrombosis or pulmonary embolism) that require a full (therapeutic)-dose DOAC regimen, appropriate for age and renal function, comprising one of (a) apixaban 2.5 mg or 5 mg bid; (b) dabigatran 110 mg or 150 mg bid; (c) edoxaban 30 mg or 60 mg daily; or (d) rivaroxaban 15 mg or 20 mg daily\n* High-risk patient having an elective high-bleed-risk surgery or any elective surgery with neuraxial anesthesia (epidural, spinal, regional) or any deep nerve root block.\n\nExclusion Criteria:\n\n* Indication for anticoagulation is unusual site thrombosis (e.g. splanchnic, cerebral, sinus, arm)\n* Receiving a low-dose DOAC regimen used for secondary VTE prevention (e.g. rivaroxaban 10 mg daily, apixaban 2.5 mg bid) or another low-dose DOAC regimen (e.g. rivaroxaban 2.5 mg bid)\n* CrCL\\<25mL/min (if on apixaban, edoxaban, rivaroxaban) or \\<30 mL/min (if on dabigatran)\n* cognitive impairment or psychiatric illness that precludes reliable contact during follow up.\n* Unable or unwilling to provide consent\n* Previous participation in PAUSE 2'}, 'identificationModule': {'nctId': 'NCT06957366', 'acronym': 'PAUSE 2 RCT', 'briefTitle': 'Perioperative Anticoagulant Use for Surgery Evaluation -2 (PAUSE-2) Study Patients Receiving a Direct Oral Anticoagulant (DOACs-Dabigatran, Rivaroxaban, Apixaban or Edoxaban) and Needing Elective High-Bleed-Risk Surgery or an Invasive Procedure', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'Perioperative Anticoagulant Use for Surgery Evaluation -2 (PAUSE-2) Study Patients Receiving a Direct Oral Anticoagulant (DOACs-Dabigatran, Rivaroxaban, Apixaban or Edoxaban) and Needing Elective High-Bleed-Risk Surgery or an Invasive Procedure: A Randomized Control Trial', 'orgStudyIdInfo': {'id': 'PAUSE 2 RCT (CTO 4938)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Apixaban', 'description': 'Patients currently taking Apixaban that have atrial fibrillation or Venous Thromboembolism and require an elective high bleed risk surgery or neuraxial anesthesia.', 'interventionNames': ['Other: PAUSE Perioperative DOAC Management', 'Other: ASRA Perioperative DOAC Management']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dabigatran', 'description': 'Patients currently taking Dabigatran that have atrial fibrillation or Venous Thromboembolism and require an elective high bleed risk surgery or neuraxial anesthesia.', 'interventionNames': ['Other: PAUSE Perioperative DOAC Management', 'Other: ASRA Perioperative DOAC Management']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Rivaroxaban', 'description': 'Patients currently taking Rivaroxaban that have atrial fibrillation or Venous Thromboembolism and require an elective high bleed risk surgery or neuraxial anesthesia.', 'interventionNames': ['Other: PAUSE Perioperative DOAC Management', 'Other: ASRA Perioperative DOAC Management']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Edoxaban', 'description': 'Patients currently taking Edoxaban that have atrial fibrillation or Venous Thromboembolism and require an elective high bleed risk surgery or neuraxial anesthesia.', 'interventionNames': ['Other: PAUSE Perioperative DOAC Management', 'Other: ASRA Perioperative DOAC Management']}], 'interventions': [{'name': 'PAUSE Perioperative DOAC Management', 'type': 'OTHER', 'description': 'PAUSE management is simple and easy to apply as patients having a high-bleed-risk surgery/neuraxial procedure interrupt DOACs for 2 days before and 2 days after surgery without heparin bridging or DOAC level testing.', 'armGroupLabels': ['Apixaban', 'Dabigatran', 'Edoxaban', 'Rivaroxaban']}, {'name': 'ASRA Perioperative DOAC Management', 'type': 'OTHER', 'description': 'ASRA management is more complex, requiring 72-120 hours DOAC interruption and, in selected patients, pre-operative heparin bridging and DOAC level testing.', 'armGroupLabels': ['Apixaban', 'Dabigatran', 'Edoxaban', 'Rivaroxaban']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06106', 'city': 'Hartford', 'state': 'Connecticut', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mandeep Kumar, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hartford Health Care', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alfonso Tafur, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'North Shore University Health', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jean Connors, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Brigham and Woman's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Scott Kaatz, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Henry Ford Health Care', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '10305', 'city': 'New York', 'state': 'New York', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alex Spyropoulos, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Northwell Health System', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Geno Merli, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Thomas Jefferson University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Leuven', 'state': 'Belgium', 'status': 'NOT_YET_RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Thomas Vanassche, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Winnipeg', 'state': 'Manitoba', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Ryan Zarychanski, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Winnipeg Health Sciences Center', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'L8N 4A6', 'city': 'Hamilton', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Ralph Laurence Gaa', 'role': 'CONTACT', 'email': 'gaar@mcmaster.ca', 'phone': '9055221155'}, {'name': 'James Douketis, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "St. Joesph's Healthcare", 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'city': 'Hamilton', 'state': 'Ontario', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Davide Matino, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Juravinski', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'K1H 8L6', 'city': 'Ottawa', 'state': 'Ontario', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Joseph Shaw, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Ottawa Hospital', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'city': 'Ottawa', 'state': 'Ontario', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Gregorie Le Gal, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "L'Hospital Montfort", 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'city': 'Toronto', 'state': 'Ontario', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Peter Gross, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Toronto General Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Larissa', 'state': 'Greece', 'status': 'NOT_YET_RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Eleni Arnaoutoglou, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Thessaly', 'geoPoint': {'lat': 39.62847, 'lon': 22.42112}}], 'centralContacts': [{'name': 'James Douketis, MD', 'role': 'CONTACT', 'email': 'jdouket@mcmaster.ca', 'phone': '905-522-1155', 'phoneExt': '36178'}, {'name': 'Melanie St John', 'role': 'CONTACT', 'email': 'stjohm1@mcmaster.ca'}], 'overallOfficials': [{'name': 'James Douketis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "McMaster University/St. Joseph's Healthcare"}, {'name': 'Joseph Shaw, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Ottawa Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No IPD data will be shared. All data reported as part of the study is aggregate data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McMaster University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. James Douketis-Principal Investigator', 'investigatorFullName': 'James Douketis', 'investigatorAffiliation': 'McMaster University'}}}}