HemorrhageNCT00672516
Management of Bleeding Following Cardiopulmonary Bypass
An observational study of Hemorrhage and Cardiopulmonary Bypass, run by University of Minnesota at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Hemorrhage, Cardiopulmonary Bypass
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to May 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75390-8894
About this study
Official title: 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.
- Conditions
- Hemorrhage, Cardiopulmonary Bypass
- Keywords
- hemorrhage, cardiopulmonary bypass, blood component transfusion, hemostasis, surgical
- Medical subject headings
- Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: First 24 hours after operation
Assess the level of compliance to the Bleeding Management Algorithm
Measured: Immediate peri-operative period
Secondary outcomes (2)
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
Measured: First 30 days post-operatively or until discharge, whichever comes first
Recording serious adverse events, such as myocardial infarction, thrombo-embolic events, etc.
Measured: First 30 days post-operatively or discharge, whichever occurs first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2008 (estimated)
- Study startApr 2008
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HemorrhageStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas Southwestern Medical Center, Johns Hopkins University, Emory University
- Responsible party
- Sponsor
- Investigators
- Marie E Steiner, MD, MS, Study chair, University of MinnesotaPhilip Greilich, MD, Principal investigator, University of Texas Souwthwestern Medical CenterNauder Faraday, MD, Principal investigator, Johns Hopkins Medical CenterNigel S Key, MB, FRCP, Principal investigator, University of North Carolina, Chapel HillJerrold Levy, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00672516
- Sponsor's protocol ID
- 0604M85353
- Other IDs
- 20100962-A1
- Status last verified
- May 2015
- First submitted
- 2 May 2008
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Steiner ME, Despotis GJ. Transfusion algorithms and how they apply to blood conservation: the high-risk cardiac surgical patient. Hematol Oncol Clin North Am. 2007 Feb;21(1):177-84. doi: 10.1016/j.hoc.2006.11.009.
PubMed 17258126Levy JH, Tanaka KA, Steiner ME. Evaluation and management of bleeding during cardiac surgery. Curr Hematol Rep. 2005 Sep;4(5):368-72.
PubMed 16131437Avidan MS, Alcock EL, Da Fonseca J, Ponte J, Desai JB, Despotis GJ, Hunt BJ. Comparison of structured use of routine laboratory tests or near-patient assessment with clinical judgement in the management of bleeding after cardiac surgery. Br J Anaesth. 2004 Feb;92(2):178-86. doi: 10.1093/bja/aeh037.
PubMed 14722166
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Excessive Bleeding Following Cardiopulmonary Bypass: A Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT00672516
- Acronym / sponsor ID
- 0604M85353
- Conditions
- Hemorrhage, Cardiopulmonary Bypass
- Keywords
- hemorrhage, cardiopulmonary bypass, blood component transfusion, hemostasis, surgical
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- University of Texas Southwestern Medical Center, Johns Hopkins University, Emory University
- Study start
- Apr 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 6 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
Assess the level of compliance to the Bleeding Management Algorithm
Time frame: Immediate peri-operative period
2 secondary outcomes
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
Recording serious adverse events, such as myocardial infarction, thrombo-embolic events, etc.
Time frame: First 30 days post-operatively or discharge, whichever occurs first
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
- Background: PubMed 17258126Steiner ME, Despotis GJ. Transfusion algorithms and how they apply to blood conservation: the high-risk cardiac surgical patient. Hematol Oncol Clin North Am. 2007 Feb;21(1):177-84. doi: 10.1016/j.hoc.2006.11.009.
- Background: PubMed 16131437Levy JH, Tanaka KA, Steiner ME. Evaluation and management of bleeding during cardiac surgery. Curr Hematol Rep. 2005 Sep;4(5):368-72.
- Background: PubMed 14722166Avidan MS, Alcock EL, Da Fonseca J, Ponte J, Desai JB, Despotis GJ, Hunt BJ. Comparison of structured use of routine laboratory tests or near-patient assessment with clinical judgement in the management of bleeding after cardiac surgery. Br J Anaesth. 2004 Feb;92(2):178-86. doi: 10.1093/bja/aeh037.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie E Steiner, MD, MS study chair
University of Minnesota
Philip Greilich, MD principal investigator
University of Texas Souwthwestern Medical Center
Nauder Faraday, MD principal investigator
Johns Hopkins Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemorrhage and Cardiopulmonary Bypass, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00672516, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2015.