- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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Texas
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Dallas, Texas, Spojené státy, 75390-8894
- University of Texas Southwestern Medical Center
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
---|---|
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
Časové okno: end of trial
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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
Časové okno: 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
Časové okno: 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
Časové okno: Immediate peri-operative period
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Immediate peri-operative period
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Sekundární výstupní opatření
Měření výsledku |
Časové okno |
---|---|
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
Časové okno: 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.
Časové okno: First 30 days post-operatively or discharge, whichever occurs first
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First 30 days post-operatively or discharge, whichever occurs first
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Studijní židle: Marie E Steiner, MD, MS, University of Minnesota
- Vrchní vyšetřovatel: Philip Greilich, MD, University of Texas Souwthwestern Medical Center
- Vrchní vyšetřovatel: Nauder Faraday, MD, Johns Hopkins Medical Center
- Vrchní vyšetřovatel: Nigel S Key, MB, FRCP, University of North Carolina, Chapel Hill
- Vrchní vyšetřovatel: Jerrold Levy, MD, Emory University
Publikace a užitečné odkazy
Obecné publikace
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 0604M85353
- 20100962-A1
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