Management of Bleeding Following Cardiopulmonary Bypass

May 26, 2015 updated by: University of Minnesota

Management of Excessive Bleeding Following Cardiopulmonary Bypass: A Pilot Feasibility Study

We believe ongoing bleeding during complex cardiac surgery can be accurately measured and that administration of a specific blood product replacement strategy designed to optimally slow or stop the bleeding can be followed by the during the operation.

Patients at risk of significant bleeding after complex cardiac surgery will be approached to allow their operation to be watched by study personnel to see if ongoing blood loss can be accurately measured and to see how quickly a prescribed, standardized blood product replacement protocol to control the bleeding does slow or stop the bleeding. Permission to review the medical record to see if bleeding risk features can be identified and permission to follow the patient after surgery to see how they recover is also requested.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Texas
  - Dallas, Texas, United States, 75390-8894
    - University of Texas Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Study populations includes male and female patients over 18 kg in weight and less than 75 years old who are undergoing cardiopulmonary bypass and are theoretically at risk for significant bleeding in the peri-operative period

Description

Inclusion Criteria:

Eligible male and female patients will include those who are over 18 kg (identified as the lower inclusion threshold so as to standardize CPB circuit dilution) and less than 75 years old (to limit excessive stroke risk) and at theoretically increased risk for excessive bleeding following cardiopulmonary bypass, including patients:

undergoing repeat sternotomy, or
undergoing combined procedures (i.e. - valve and coronary artery surgery), or
undergoing multiple valve surgery, or
undergoing aortic root replacement with/without deep hypothermic circulatory arrest, or
undergoing complex congenital cardiac surgery

Exclusion Criteria:

Ineligible patients include those:

with known coagulation factor deficiency, or
refusing to receive donor blood products if necessary, or
undergoing emergency surgery, or
undergoing their first coronary artery bypass surgery or their first valve repair/replacement, or
with history of previous stroke or other significant thromboembolic event within 6 months (such as pulmonary embolism, valve obstruction [if not replacing this valve in upcoming operation], renal vein thrombosis, acute MI, DVT ), or
with known thrombophilia, or
with active infection (bacteremia, sepsis, endocarditis, meningitis, urinary tract infection, cholecystitis, cellulitis, pneumonia)
pregnant, or
weight > 150 kg or < 18 kg

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Tabulate the number of high risk subjects that must be screened and consented in order to find twenty subjects that meet the criteria of excessive bleeding following conventional therapy Time Frame: end of trial	end of trial
Determine blood loss, bleeding rate and blood transfusion prior to and following completion of algorithm-guided conventional transfusion therapy,including measured loss, rate of loss, volume of transfusion Time Frame: During and immediately following completion of bypass OR in the first 24 hours after admission to the IUC, if significant bleeding occurs	During and immediately following completion of bypass OR in the first 24 hours after admission to the IUC, if significant bleeding occurs
Assess the relative accuracy and clinical relevance of measuring bleeding rate, blood loss and blood transfusion in the first 24 hours following designation of "excessive bleeding", including measured hourly outputs, rate of output and volume transfused Time Frame: First 24 hours after operation	First 24 hours after operation
Assess the level of compliance to the Bleeding Management Algorithm Time Frame: Immediate peri-operative period	Immediate peri-operative period

Secondary Outcome Measures

Outcome Measure	Time Frame
Tabulating adverse outcomes, including: 1) rate of re-exploration within the next 24 hours, 2) use of rescue therapeutics in accordance with local practice, and 3) mortality within 30 days Time Frame: First 30 days post-operatively or until discharge, whichever comes first	First 30 days post-operatively or until discharge, whichever comes first
Recording serious adverse events, such as myocardial infarction, thrombo-embolic events, etc. Time Frame: First 30 days post-operatively or discharge, whichever occurs first	First 30 days post-operatively or discharge, whichever occurs first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Collaborators

Johns Hopkins University

Emory University

University of Texas Southwestern Medical Center

Investigators

Study Chair: Marie E Steiner, MD, MS, University of Minnesota
Principal Investigator: Philip Greilich, MD, University of Texas Souwthwestern Medical Center
Principal Investigator: Nauder Faraday, MD, Johns Hopkins Medical Center
Principal Investigator: Nigel S Key, MB, FRCP, University of North Carolina, Chapel Hill
Principal Investigator: Jerrold Levy, MD, Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)