NCT01481012

Brief Summary

The purpose of this study is to obtain data or information on how blood clotting factors are activated during open heart surgery. In particular, the investigators are interested in how blood clotting factors are activated by the heart-lung bypass machine and by left ventricular assist devices (LVAD). Patients on these two machines have an increased risk of bleeding and blood clot formation. This is because both machines stimulate the intrinsic coagulation pathway, one of the chemical pathways that cause blood to clot. The process of surgery itself also stimulates the "extrinsic coagulation pathway," the other chemical pathway that causes blood to clot. Stimulating these coagulation pathways can use up the body's clotting factors. As a result, patients may be at risk for both bleeding and blood clot formation. The investigators would like to study how the blood factors are activated during and after surgery, to help develop treatments to prevent bleeding and clot formation.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

13 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

November 7, 2011

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 29, 2011

Completed
Last Updated

November 29, 2011

Status Verified

November 1, 2011

Enrollment Period

1.5 years

First QC Date

November 7, 2011

Last Update Submit

November 23, 2011

Conditions

Congestive Heart Failure

Keywords

Heart transplantationCoronary artery bypass graft (CABG) surgeryLeft ventricular assist device implantation surgeries

Outcome Measures

Primary Outcomes (8)

  • Thrombin Generation Markers

    We will compare the following endpoints among the cardiac transplant, CABG, and LVAD recipients: Thrombin Generation Markers: Assays will be performed to quantify the levels of the following markers at the specified time points: Thrombo-antithrombin complex (TAT), Prothrombin Fragment 1 +2 (F1.2), and Thromboelastography (TEG) will be performed when available to assess platelet function.

    At time of surgery (before initiation of Cardiopulmonary Bypass)

  • Thrombin Generation Markers

    We will compare the following endpoints among the cardiac transplant, CABG, and LVAD recipients: Thrombin Generation Markers: Assays will be performed to quantify the levels of the following markers at the specified time points: Thrombo-antithrombin complex (TAT), Prothrombin Fragment 1 +2 (F1.2), and Thromboelastography (TEG) will be performed when available to assess platelet function.

    At time of surgery (dismantling the sterile environment)

  • Thrombin Generation Markers

    We will compare the following endpoints among the cardiac transplant, CABG, and LVAD recipients: Thrombin Generation Markers: Assays will be performed to quantify the levels of the following markers at the specified time points: Thrombo-antithrombin complex (TAT), Prothrombin Fragment 1 +2 (F1.2), and Thromboelastography (TEG) will be performed when available to assess platelet function.

    Post-operative day 1

  • Thrombin Generation Markers

    We will compare the following endpoints among the cardiac transplant, CABG, and LVAD recipients: Thrombin Generation Markers: Assays will be performed to quantify the levels of the following markers at the specified time points: Thrombo-antithrombin complex (TAT), Prothrombin Fragment 1 +2 (F1.2), and Thromboelastography (TEG) will be performed when available to assess platelet function.

    At time of surgery

  • Thrombin Generation Markers

    We will compare the following endpoints among the cardiac transplant, CABG, and LVAD recipients: Thrombin Generation Markers: Assays will be performed to quantify the levels of the following markers at the specified time points: Thrombo-antithrombin complex (TAT), Prothrombin Fragment 1 +2 (F1.2), and Thromboelastography (TEG) will be performed when available to assess platelet function.

    Post-operative day12 (while remaining in hosp)

  • Thrombin Generation Markers

    We will compare the following endpoints among the cardiac transplant, CABG, and LVAD recipients: Thrombin Generation Markers: Assays will be performed to quantify the levels of the following markers at the specified time points: Thrombo-antithrombin complex (TAT), Prothrombin Fragment 1 +2 (F1.2), and Thromboelastography (TEG) will be performed when available to assess platelet function.

    Post-operative day 16 (while remaining in hosp)

  • Thrombin Generation Markers

    We will compare the following endpoints among the cardiac transplant, CABG, and LVAD recipients: Thrombin Generation Markers: Assays will be performed to quantify the levels of the following markers at the specified time points: Thrombo-antithrombin complex (TAT), Prothrombin Fragment 1 +2 (F1.2), and Thromboelastography (TEG) will be performed when available to assess platelet function.

    Post-operative day 20 (while remaining in hosp)

  • Thrombin Generation Markers

    We will compare the following endpoints among the cardiac transplant, CABG, and LVAD recipients: Thrombin Generation Markers: Assays will be performed to quantify the levels of the following markers at the specified time points: Thrombo-antithrombin complex (TAT), Prothrombin Fragment 1 +2 (F1.2), and Thromboelastography (TEG) will be performed when available to assess platelet function.

    Post-operative day 24 (while remaining in hosp)

Secondary Outcomes (33)

  • Bleeding

    At time of surgery (dismantling of the sterile environment)

  • Bleeding

    Post-operative day 1

  • Bleeding

    Post-operative day 12 (± 3 days) (or at time of discharge, whichever comes first)

  • Bleeding

    Post-operative day 20 (± 3 days) (or at time of discharge, whichever comes first)

  • Bleeding

    Post-operative day 28 (± 3 days) (or at time of discharge, whichever comes first)

  • +28 more secondary outcomes

Study Arms (4)

Group I: Cardiopulmonary Bypass + Heart Transplantation

CPB for orthotopic heart transplantation (excluding any patients with VADs)

Group II: Cardiopulmonary Bypass + Pulsatile LVAD

CPB for implantation of a Thoratec HeartMate I LVAD (for destination therapy or bridge to transplantation).

Group III: Cardiopulmonary Bypass + Continuous Flow LVAD

CPB for implantation of an axial flow or centrifugal flow LVAD (for destination therapy or bridge to transplantation) (e.g. HeartMate II, DeBakey VAD or VentraAssist LVAS)

Group IV: Cardiopulmonary Bypass + CABG Surgery

CPB for CABG surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with underlying systolic ventricular dysfunction who will undergo heart transplantation, CABG surgery, implantation of a pulsatile LVAD, or implantation of a continuous flow LVAD (as destination therapy or bridge to transplantation) within 24 hours of enrollment, are candidates for this study.

You may qualify if:

  • Signed informed consent, release of medical information, and HIPAA forms;
  • Age greater than or equal to 18 years;
  • Male, postmenopausal female, or female who may become pregnant but is using adequate contraceptive precautions (defined as oral contraceptive, intrauterine devices, surgical contraception or a combination of a condom and a spermicide), with negative pregnancy test;
  • Admitted to the clinical center at the time of enrollment;
  • Approved and scheduled to undergo one of the following within 24 hours of enrollment:
  • Orthotopic heart transplantation
  • CABG and/or valve surgery on CPB; these patients must have an LV ejection fraction of ≤35%
  • Implantation of a pulsatile LVAD (e.g.Thoratec HeartMate® I LVAD) for destination therapy or bridge to transplantation
  • Implantation of a continuous flow LVAD (e.g. HeartMate® II, DeBakey VAD® or VentrAssist® LVAS) for destination therapy or bridge to transplantation

You may not qualify if:

  • History of a platelet disorder;
  • History of a known, or an inherited, or an acquired coagulation disorder in the study subject;
  • Stroke within 30 days prior to enrollment;
  • Allergy to heparin or protamine;
  • Participation in a clinical investigational intervention trial, with the exception of an investigational VAD trial, at the time of enrollment;
  • Received investigational intervention within 30 days of enrollment, with the exception of an investigational VAD trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Sharp Memorial Hospital

San Diego, California, 92123, United States

Location

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

Location

Jewish Hospital

Louisville, Kentucky, 40202, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Columbia Presbyterian Medical Center

New York, New York, 10032, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

LDS Hospital

Salt Lake City, Utah, 84143, United States

Location

Sacred Heart Medical Center

Spokane, Washington, 99204, United States

Location

University of Wisconsin Hospital

Madison, Wisconsin, 53792, United States

Location

St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood for the following markers of thrombin generation and platelet function will be drawn, spun, aliquoted and stored for later batched analysis: - Thrombo-antithrombin complex (TAT); - Prothrombin Fragment 1+2 (F1.2); - Thromboelastrograph (TEG) (performed at the clinical site when available); - Additional markers of coagulation and platelet activation (for future consideration) - 4ml of plasma frozen in 1ml aliquots.

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Patrice Desvigne-Nickens

    National Heart, Lung, and Blood Institute (NHLBI)

    STUDY DIRECTOR

  • Yoshifumi Naka, MD

    Columbia University

    STUDY CHAIR

  • Annetine Gelijns, PhD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2011

First Posted

November 29, 2011

Study Start

January 1, 2006

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

November 29, 2011

Record last verified: 2011-11

Locations

US(13)