- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00672516
Management of Bleeding Following Cardiopulmonary Bypass
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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
Texas
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Dallas, Texas, Forenede Stater, 75390-8894
- University of Texas Southwestern Medical Center
-
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
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
Tidsramme: end of trial
|
end of trial
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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
Tidsramme: During and immediately following completion of bypass OR in the first 24 hours after admission to the IUC, if significant bleeding occurs
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During and immediately following completion of bypass OR in the first 24 hours after admission to the IUC, if significant bleeding occurs
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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
Tidsramme: First 24 hours after operation
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First 24 hours after operation
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Assess the level of compliance to the Bleeding Management Algorithm
Tidsramme: Immediate peri-operative period
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Immediate peri-operative period
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
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
Tidsramme: First 30 days post-operatively or until discharge, whichever comes first
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First 30 days post-operatively or until discharge, whichever comes first
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Recording serious adverse events, such as myocardial infarction, thrombo-embolic events, etc.
Tidsramme: First 30 days post-operatively or discharge, whichever occurs first
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First 30 days post-operatively or discharge, whichever occurs first
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Marie E Steiner, MD, MS, University of Minnesota
- Ledende efterforsker: Philip Greilich, MD, University of Texas Souwthwestern Medical Center
- Ledende efterforsker: Nauder Faraday, MD, Johns Hopkins Medical Center
- Ledende efterforsker: Nigel S Key, MB, FRCP, University of North Carolina, Chapel Hill
- Ledende efterforsker: Jerrold Levy, MD, Emory University
Publikationer og nyttige links
Generelle publikationer
- 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.
- Levy JH, Tanaka KA, Steiner ME. Evaluation and management of bleeding during cardiac surgery. Curr Hematol Rep. 2005 Sep;4(5):368-72.
- Avidan 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 0604M85353
- 20100962-A1
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