ClinicalTrials.gov
History of Changes for Study: NCT04976530
Safe and Timely Antithrombotic Removal - Ticagrelor (STAR-T) (STAR-T)
Latest version (submitted January 29, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 15, 2021 None (earliest Version on record)
2 August 27, 2021 Study Status and Contacts/Locations
3 September 1, 2021 Recruitment Status, Study Status and Contacts/Locations
4 September 13, 2021 Contacts/Locations and Study Status
5 September 27, 2021 Contacts/Locations and Study Status
6 September 30, 2021 Contacts/Locations and Study Status
7 October 11, 2021 Study Status and Contacts/Locations
8 October 14, 2021 Contacts/Locations and Study Status
9 October 18, 2021 Contacts/Locations and Study Status
10 December 7, 2021 Contacts/Locations and Study Status
11 December 28, 2021 Contacts/Locations and Study Status
12 February 8, 2022 Contacts/Locations and Study Status
13 February 14, 2022 Contacts/Locations and Study Status
14 March 4, 2022 Study Status and Contacts/Locations
15 March 8, 2022 Contacts/Locations and Study Status
16 March 25, 2022 Contacts/Locations, Eligibility, Study Description, Study Status and Study Identification
17 April 13, 2022 Contacts/Locations and Study Status
18 May 4, 2022 Contacts/Locations and Study Status
19 June 1, 2022 Study Status and Contacts/Locations
20 June 13, 2022 Contacts/Locations and Study Status
21 June 23, 2022 Contacts/Locations and Study Status
22 July 6, 2022 Contacts/Locations and Study Status
23 July 20, 2022 Contacts/Locations and Study Status
24 October 3, 2022 Contacts/Locations and Study Status
25 October 13, 2022 Contacts/Locations and Study Status
26 October 13, 2022 Contacts/Locations and Study Status
27 October 28, 2022 Contacts/Locations and Study Status
28 November 17, 2022 Contacts/Locations and Study Status
29 December 2, 2022 Contacts/Locations and Study Status
30 February 2, 2023 Contacts/Locations and Study Status
31 February 16, 2023 Contacts/Locations and Study Status
32 February 17, 2023 Contacts/Locations and Study Status
33 March 17, 2023 Study Status and Contacts/Locations
34 March 30, 2023 Contacts/Locations and Study Status
35 April 5, 2023 Study Status and Contacts/Locations
36 April 26, 2023 Contacts/Locations and Study Status
37 May 4, 2023 Study Status and Contacts/Locations
38 May 18, 2023 Contacts/Locations and Study Status
39 May 24, 2023 Contacts/Locations and Study Status
40 June 27, 2023 Contacts/Locations and Study Status
41 July 7, 2023 Recruitment Status, Study Status, Contacts/Locations and Study Design
42 January 29, 2024 Recruitment Status and Study Status
Comparison Format:
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Changes (Side-by-Side) for Study: NCT04976530
June 27, 2023 (v40) -- July 7, 2023 (v41)

Changes in: Study Status, Study Design and Contacts/Locations
Open or close this module Study Identification
Unique Protocol ID: 2021-01 2021-01
Brief Title: Safe and Timely Antithrombotic Removal - Ticagrelor (STAR-T) (STAR-T)Safe and Timely Antithrombotic Removal - Ticagrelor (STAR-T) (STAR-T)
Official Title: Safe and Timely Antithrombotic Removal - Ticagrelor (STAR-T): A Prospective, Multicenter, Double-blind, Randomized, Study to Evaluate Reduction in Postoperative Bleeding by Removal of Ticagrelor With the Intraoperative Use of the DrugSorb-ATR Device in Patients Undergoing On-pump Cardiothoracic Surgery Within Two Days of Ticagrelor Discontinuation Safe and Timely Antithrombotic Removal - Ticagrelor (STAR-T): A Prospective, Multicenter, Double-blind, Randomized, Study to Evaluate Reduction in Postoperative Bleeding by Removal of Ticagrelor With the Intraoperative Use of the DrugSorb-ATR Device in Patients Undergoing On-pump Cardiothoracic Surgery Within Two Days of Ticagrelor Discontinuation
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2023 July 2023
Overall Status: RecruitingActive, not recruiting
Study Start: August 31, 2021 August 31, 2021
Primary Completion: July 2023 [Anticipated] December 2023 [Anticipated]
Study Completion: December 2023 [Anticipated] December 2023 [Anticipated]
First Submitted: July 6, 2021 July 6, 2021
First Submitted that
Met QC Criteria:		 July 15, 2021 July 15, 2021
First Posted: July 26, 2021 [Actual] July 26, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:		 June 27, 2023 July 7, 2023
Last Update Posted: June 28, 2023 [Actual] July 10, 2023 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: CytoSorbents, Inc CytoSorbents, Inc
Responsible Party: Sponsor Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: NoNo
U.S. FDA-regulated Device: YesYes
Unapproved/Uncleared Device: YesYes
Pediatric Postmarket Surveillance:
Data Monitoring: Yes Yes
Open or close this module Study Description
Brief Summary: Prospective, multi-center, double-blind, randomized pivotal trial to evaluate the safety and effectiveness of the DrugSorb-ATR system for intraoperative removal of ticagrelor in patients undergoing urgent cardiothoracic (CT) surgery with cardiopulmonary bypass (CPB). Prospective, multi-center, double-blind, randomized pivotal trial to evaluate the safety and effectiveness of the DrugSorb-ATR system for intraoperative removal of ticagrelor in patients undergoing urgent cardiothoracic (CT) surgery with cardiopulmonary bypass (CPB).
Detailed Description:
Open or close this module Conditions
Conditions: Hemorrhage, Surgical
Blood Loss, Surgical
Blood Loss, Postoperative
Hemorrhage Postoperative 		Hemorrhage, Surgical
Blood Loss, Surgical
Blood Loss, Postoperative
Hemorrhage Postoperative
Keywords:
Open or close this module Study Design
Study Type: InterventionalInterventional
Primary Purpose: TreatmentTreatment
Study Phase: Not ApplicableNot Applicable
Interventional Study Model: Parallel Assignment Parallel Assignment
Number of Arms: 22
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: RandomizedRandomized
Enrollment: 120 [Anticipated] 140 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Sham Comparator: Control
Standard of care with Sham set-up
 Device: Sham comparator
Sham comparator in similar position to the investigative device, but NOT integrated into the cardiopulmonary (CPB) circuit
Experimental: DrugSorb-ATR Intervention
Standard of care + DrugSorb-ATR system
 Device: DrugSorb-ATR system
Sorbent hemoperfusion system integrated into the cardiopulmonary bypass (CPB) circuit
Other Names:
  • Sorbent hemoperfusion system
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Incidence of peri-operative bleeding
[ Time Frame: Through the first 48hrs post-operation ]

Incidence of clinically significant peri-operative bleeding events, as evaluated by a ranked composite endpoint 		Incidence of peri-operative bleeding
[ Time Frame: Through the first 48hrs post-operation ]

Incidence of clinically significant peri-operative bleeding events, as evaluated by a ranked composite endpoint
Secondary Outcome Measures:
1. Ticagrelor removal
[ Time Frame: Through 30min post-CPB ]

Change in blood ticagrelor levels 		Ticagrelor removal
[ Time Frame: Through 30min post-CPB ]

Change in blood ticagrelor levels
2. Chest tube drainage
[ Time Frame: Through 24hrs post-operation ]

Drainage volume from all chest and mediastinal tubes 		Chest tube drainage
[ Time Frame: Through 24hrs post-operation ]

Drainage volume from all chest and mediastinal tubes
3. PRBC transfusions (volume)
[ Time Frame: Through to discharge from index hospitalization, on average 1-2 weeks ]

Total PRBC transfusions (mL) during hospitalization 		PRBC transfusions (volume)
[ Time Frame: Through to discharge from index hospitalization, on average 1-2 weeks ]

Total PRBC transfusions (mL) during hospitalization
4. PRBC transfusions (units)
[ Time Frame: Through to discharge from index hospitalization, on average 1-2 weeks ]

Total PRBC transfusions (units) during hospitalization 		PRBC transfusions (units)
[ Time Frame: Through to discharge from index hospitalization, on average 1-2 weeks ]

Total PRBC transfusions (units) during hospitalization
5. Platelet transfusions (volume)
[ Time Frame: Through to discharge from index hospitalization, on average 1-2 weeks ]

Total Platelet transfusions (mL) during hospitalization 		Platelet transfusions (volume)
[ Time Frame: Through to discharge from index hospitalization, on average 1-2 weeks ]

Total Platelet transfusions (mL) during hospitalization
6. Platelet transfusions (units)
[ Time Frame: Through to discharge from index hospitalization, on average 1-2 weeks ]

Total Platelet transfusions (units) during hospitalization 		Platelet transfusions (units)
[ Time Frame: Through to discharge from index hospitalization, on average 1-2 weeks ]

Total Platelet transfusions (units) during hospitalization
7. Incidence of moderate, severe, and massive peri-operative bleeding events
[ Time Frame: Through the first day post-operation ]

Peri-operative bleeding events classified according to the Universal Definition of Peri-operative Bleeding, and analyzed by class (Class 0; 1; 2; 3; 4) 		Incidence of moderate, severe, and massive peri-operative bleeding events
[ Time Frame: Through the first day post-operation ]

Peri-operative bleeding events classified according to the Universal Definition of Peri-operative Bleeding, and analyzed by class (Class 0; 1; 2; 3; 4)
8. Re-exploration for bleeding
[ Time Frame: Through to discharge from index hospitalization, on average 1-2 weeks ]

All surgical re-explorations for excessive bleeding, as classified by an independent CEC 		Re-exploration for bleeding
[ Time Frame: Through to discharge from index hospitalization, on average 1-2 weeks ]

All surgical re-explorations for excessive bleeding, as classified by an independent CEC
9. Incidence of fatal peri-operative bleeding
[ Time Frame: Through to discharge from index hospitalization, on average 1-2 weeks ]

Deaths directly attributable to procedure-related bleeding, as adjudicated by an independent CEC 		Incidence of fatal peri-operative bleeding
[ Time Frame: Through to discharge from index hospitalization, on average 1-2 weeks ]

Deaths directly attributable to procedure-related bleeding, as adjudicated by an independent CEC
Open or close this module Eligibility
Minimum Age: 18 Years 18 Years
Maximum Age:
Sex: All All
Gender Based:
Accepts Healthy Volunteers: NoNo
Criteria:

Inclusion Criteria:

  1. Male or female 18 years of age or older, with documented full, written informed consent
  2. Requiring cardiothoracic (CT) surgery with cardiopulmonary bypass (CPB) within two days of ticagrelor discontinuation (day of last dose = day 0)

Exclusion Criteria:

  1. CT surgery occurring 3 days or greater following ticagrelor discontinuation
  2. Heart-lung transplant procedures
  3. Procedures for ventricular assist device (implant/revision of LVAD or RVAD)
  4. Pre-existing conditions that pose a known risk for bleeding (i.e., HITT, perioperative platelet count < 50,000u/L, hemophilia, and INR >1.5)
  5. Prohibited concomitant antithrombotic medications as defined in the study protocol
  6. Acute sickle cell crisis
  7. Known allergy to device components
  8. Active (untreated) systemic infection
  9. History of major organ transplantation and those currently receiving immunosuppressive medication or who are profoundly immune suppressed
  10. Women with positive pregnancy test during current admission or who are breast-feeding
  11. Life expectancy <30 days
  12. Inability to comply with requirements of the study protocol
  13. Treatment with investigational drug or device within 30 days of current surgery
  14. Previous enrollment in this trial

Inclusion Criteria:

  1. Male or female 18 years of age or older, with documented full, written informed consent
  2. Requiring cardiothoracic (CT) surgery with cardiopulmonary bypass (CPB) within two days of ticagrelor discontinuation (day of last dose = day 0)

Exclusion Criteria:

  1. CT surgery occurring 3 days or greater following ticagrelor discontinuation
  2. Heart-lung transplant procedures
  3. Procedures for ventricular assist device (implant/revision of LVAD or RVAD)
  4. Pre-existing conditions that pose a known risk for bleeding (i.e., HITT, perioperative platelet count < 50,000u/L, hemophilia, and INR >1.5)
  5. Prohibited concomitant antithrombotic medications as defined in the study protocol
  6. Acute sickle cell crisis
  7. Known allergy to device components
  8. Active (untreated) systemic infection
  9. History of major organ transplantation and those currently receiving immunosuppressive medication or who are profoundly immune suppressed
  10. Women with positive pregnancy test during current admission or who are breast-feeding
  11. Life expectancy <30 days
  12. Inability to comply with requirements of the study protocol
  13. Treatment with investigational drug or device within 30 days of current surgery
  14. Previous enrollment in this trial
Open or close this module Contacts/Locations
Central Contact Person: Jodi Hoover
Telephone: 732-783-4764
Email: jhoover@cytosorbents.com
Study Officials: Michael J Mack, MD
Principal Investigator
Baylor Scott & White The Heart Hospital 		Michael J Mack, MD
Principal Investigator
Baylor Scott & White The Heart Hospital
C. M Gibson, MD
Principal Investigator
Beth Israel Deaconess Medical Center, The Baim Institute, and Harvard Medical School 		C. M Gibson, MD
Principal Investigator
Beth Israel Deaconess Medical Center, The Baim Institute, and Harvard Medical School
Richard Whitlock, MD
Principal Investigator
Hamilton General Hospital 		Richard Whitlock, MD
Principal Investigator
Hamilton General Hospital
Locations: United States, CaliforniaUnited States, California
University of California, Davis Medical Center
[Recruiting]
Sacramento, California, United States, 95817
Contact:Contact: Journne Herrera
Contact:Principal Investigator: Sabrina Evans, MD 		University of California, Davis Medical Center
Sacramento, California, United States, 95817
United States, ConnecticutUnited States, Connecticut
Yale New Haven Hospital
[Recruiting]
New Haven, Connecticut, United States, 06510
Contact:Contact: Ricarda Tomlin
Contact:Principal Investigator: Patrick Davis, MD 		Yale New Haven Hospital
New Haven, Connecticut, United States, 06510
United States, District of ColumbiaUnited States, District of Columbia
MedStar Health Research Institute
[Recruiting]
Washington, District of Columbia, United States, 20010
Contact:Contact: Kate Mahoney
Contact:Principal Investigator: Christian Shults, MD 		MedStar Health Research Institute
Washington, District of Columbia, United States, 20010
United States, Florida
Baptist Hospital of Miami
[Withdrawn]
Miami, Florida, United States, 33176
Advent Health
[Withdrawn]
Orlando, Florida, United States, 32803
United States, GeorgiaUnited States, Georgia
Emory University Hospital Midtown/Emory School of Medicine
[Active, not recruiting]
Atlanta, Georgia, United States, 30308		Emory University Hospital Midtown/Emory School of Medicine
Atlanta, Georgia, United States, 30308
Piedmont Heart Institute
[Withdrawn]
Atlanta, Georgia, United States, 30309
Emory Saint Joseph's Hospital
[Withdrawn]
Atlanta, Georgia, United States, 30342
United States, IndianaUnited States, Indiana
Lutheran Medical Group
[Recruiting]
Fort Wayne, Indiana, United States, 46804
Contact:Contact: Sharon Eichman, RN
Contact:Principal Investigator: Hannah Copeland, MD 		Lutheran Medical Group
Fort Wayne, Indiana, United States, 46804
United States, IowaUnited States, Iowa
University of Iowa
[Recruiting]
Iowa City, Iowa, United States, 52242
Contact:Contact: Cody Poe, MS
Contact:Principal Investigator: Mohammad Bashir, MD 		University of Iowa
Iowa City, Iowa, United States, 52242
United States, MarylandUnited States, Maryland
University of Maryland Medical Center
[Recruiting]
Baltimore, Maryland, United States, 21201
Contact:Contact: Manal Al-Suqi
Contact:Principal Investigator: Bradley Taylor, MD
Contact:Sub-Investigator: Reney Henderson, MD 		University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
United States, MassachusettsUnited States, Massachusetts
Massachusetts General Hospital
[Recruiting]
Boston, Massachusetts, United States, 02114
Contact:Contact: Annika Gallandt
Contact:Principal Investigator: Nathaniel B Langer, MD 		Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
[Recruiting]
Boston, Massachusetts, United States, 02215
Contact:Contact: Debbie Conboy, RN
Contact:Principal Investigator: David Liu, MD
Contact:Sub-Investigator: Duane Pinto, MD 		Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
Henry Ford Health System
[Withdrawn]
Detroit, Michigan, United States, 48202
United States, Minnesota
University of Minnesota
[Withdrawn]
Minneapolis, Minnesota, United States, 55455
United States, MississippiUnited States, Mississippi
University of Mississippi
[Recruiting]
Jackson, Mississippi, United States, 39216
Contact:Contact: Stephanie Moore, RN
Contact:Principal Investigator: Adam Protos, MD 		University of Mississippi
Jackson, Mississippi, United States, 39216
United States, Missouri
St. Luke's Hospital of Kansas City
[Withdrawn]
Kansas City, Missouri, United States, 64111
United States, Nebraska
Bryan Medical Center
[Withdrawn]
Lincoln, Nebraska, United States, 68506
United States, New JerseyUnited States, New Jersey
Virtua Health
[Recruiting]
Marlton, New Jersey, United States, 08053
Contact:Contact: Danielle Connors
Contact:Principal Investigator: Chun Choi, MD 		Virtua Health
Marlton, New Jersey, United States, 08053
Jersey Shore University Medical Center
[Recruiting]
Neptune, New Jersey, United States, 07753
Contact:Contact: Anne DeToro, RN
Contact:Principal Investigator: Richard Neibart, MD 		Jersey Shore University Medical Center
Neptune, New Jersey, United States, 07753
United States, New YorkUnited States, New York
New York University Langone Health
[Recruiting]
New York, New York, United States, 10016
Contact:Contact: Lucy Lannan
Contact:Principal Investigator: Elias A Zias, MD
Contact:Sub-Investigator: Daniel G Swistel, MD 		New York University Langone Health
New York, New York, United States, 10016
Columbia University
[Withdrawn]
New York, New York, United States, 10032
United States, OhioUnited States, Ohio
University Hospitals, Cleveland Medical Center
[Recruiting]
Cleveland, Ohio, United States, 44106
Contact:Contact: Stacey Mazzurco, RN
Contact:Principal Investigator: Marc Pelletier, MD 		University Hospitals, Cleveland Medical Center
Cleveland, Ohio, United States, 44106
United States, Rhode IslandUnited States, Rhode Island
Rhode Island Hospital
[Recruiting]
Providence, Rhode Island, United States, 02903
Contact:Contact: Lori-Ann DeSimone, RN
Contact:Principal Investigator: Neel R Sodha, MD 		Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, South CarolinaUnited States, South Carolina
Medical University of South Carolina
[Recruiting]
Charleston, South Carolina, United States, 29425
Contact:Contact: Morgan Overstreet, MSc
Contact:Principal Investigator: Arman Kilic, MD 		Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
Baylor College of Medicine
[Withdrawn]
Houston, Texas, United States, 77030
United States, Texas
Baylor Scott & White The Heart Hospital Plano
[Recruiting]
Plano, Texas, United States, 75093
Contact:Contact: Megan White, MS
Contact:Principal Investigator: J. M DiMaio, MD 		Baylor Scott & White The Heart Hospital Plano
Plano, Texas, United States, 75093
United States, VermontUnited States, Vermont
University of Vermont Medical Center
[Active, not recruiting]
Burlington, Vermont, United States, 05401		University of Vermont Medical Center
Burlington, Vermont, United States, 05401
United States, VirginiaUnited States, Virginia
VCU Medical Center
[Recruiting]
Richmond, Virginia, United States, 23219
Contact:Contact: Jinfeng Han
Contact:Principal Investigator: Patricia A Nicolato, DO 		VCU Medical Center
Richmond, Virginia, United States, 23219
Carilion Clinic
[Recruiting]
Roanoke, Virginia, United States, 24014
Contact:Contact: Ambili John
Contact:Principal Investigator: Joseph W Baker, MD 		Carilion Clinic
Roanoke, Virginia, United States, 24014
United States, WisconsinUnited States, Wisconsin
University of Wisconsin-Madison
[Recruiting]
Madison, Wisconsin, United States, 53792
Contact:Contact: Kaelin M Grant
Contact:Principal Investigator: Chris Rokkas, MD 		University of Wisconsin-Madison
Madison, Wisconsin, United States, 53792
The Medical College of Wisconsin, Inc.
[Recruiting]
Milwaukee, Wisconsin, United States, 53226
Contact:Contact: James Zelten
Contact:Principal Investigator: Lucian Durham, MD, PhD 		The Medical College of Wisconsin, Inc.
Milwaukee, Wisconsin, United States, 53226
Canada, ManitobaCanada, Manitoba
St. Boniface Hospital
[Recruiting]
Winnipeg, Manitoba, Canada, R2H 2A6
Contact:Contact: David Kent
Contact:Principal Investigator: Nitin Ghorpade, MD 		St. Boniface Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, OntarioCanada, Ontario
Hamilton General Hospital, Hamilton Health Sciences Corporation
[Recruiting]
Hamilton, Ontario, Canada, L8L 2X2
Contact:Contact: Leah Hayward, MSc
Contact:Principal Investigator: Richard Whitlock, MD, PhD 		Hamilton General Hospital, Hamilton Health Sciences Corporation
Hamilton, Ontario, Canada, L8L 2X2
Kingston Health Sciences Centre
[Recruiting]
Kingston, Ontario, Canada, K7L 2V7
Contact:Contact: Debbie DuMerton
Contact:Principal Investigator: Tarit Saha, MD 		Kingston Health Sciences Centre
Kingston, Ontario, Canada, K7L 2V7
London Health Sciences Centre, University Hospital
[Recruiting]
London, Ontario, Canada, N6A 5A5
Contact:Contact: Stephanie Fox, BA, RRT
Contact:Principal Investigator: Michael Chu, MD 		London Health Sciences Centre, University Hospital
London, Ontario, Canada, N6A 5A5
St. Michael's Hospital, Unity Health Toronto
[Recruiting]
Toronto, Ontario, Canada, M5B 1W8
Contact:Contact: Samson Moses
Contact:Principal Investigator: David Mazer, MD 		St. Michael's Hospital, Unity Health Toronto
Toronto, Ontario, Canada, M5B 1W8
Canada, QuebecCanada, Quebec
Montreal Heart Institute
[Recruiting]
Montréal, Quebec, Canada, H1T 1C8
Contact:Contact: Alexandre Bergeron
Contact:Principal Investigator: Philippe Demers, MD 		Montreal Heart Institute
Montréal, Quebec, Canada, H1T 1C8
Institut Universitaire de Cardiologie et de Pneumologie de Québec - Université Laval
[Recruiting]
Québec, Quebec, Canada, G1V 4G5
Contact:Contact: Annie Bergeron
Contact:Principal Investigator: Pierre Voisine, MD 		Institut Universitaire de Cardiologie et de Pneumologie de Québec - Université Laval
Québec, Quebec, Canada, G1V 4G5
Open or close this module IPDSharing
Plan to Share IPD: No No
Open or close this module References
Links:
Available IPD/Information:
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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services