- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00888940
Outcomes and Safety Trial Investigating Ecallantide's Effect on Reducing Surgical Blood Loss Volume in Subjects at High Risk of Bleeding Exposed to Cardio-pulmonary Bypass During Cardiac Surgery (CONSERV-2)
21. juli 2015 opdateret af: Cubist Pharmaceuticals LLC
CONSERV - 2 (Clinical Outcomes and Safety Trial to Investigate Ecallantide's Effect on Reducing Surgical Blood Loss Volume) - A Phase 2 Randomized Double-Blind Active-Controlled Study in Subjects Exposed to Cardio-pulmonary Bypass During Cardiac Surgery at High Risk of Bleeding
A Phase 2 Randomized Double-Blind Active-Controlled Study in Subjects Exposed to Cardio-pulmonary Bypass During Cardiac Surgery at High Risk of Bleeding
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
243
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Alabama
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Birmingham, Alabama, Forenede Stater, 35205
- Cardio-Thoracic Surgeons PC
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Bialystok, Polen, 15-276
- Uniwersytecki Szpital Kliniczny w Bialymstoku
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Bydgoszcz, Polen, 85-094
- Szpital Uniwersytecki im. Dr. Antoniego Jurasza w Bydgoszczy
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Gdansk, Polen, 80-952
- Akademickie Centrum Kliniczne, Szpital AM w Gdansku
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Katowice, Polen, 40-635
- Samodzielny Publiczny Szpital Kliniczny nr 7 Slaskiego Uniwersytetu Medycznego w Katowicach
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Kraków, Polen, 31-200
- Krakowski Szpital Specjalistyczny Im. Jana Pawla Ii
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Lódz, Polen, 91-425
- Uniwersytecki Szpital Kliniczny Nr. 3 im. Dr Seweryna Sterlinga
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Poznan, Polen, 61-833
- Katedra Chorób Serca AM, Szpital Miejski im. J Strusia
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Szczecin, Polen, 70-111
- Samodzielny Publiczny Szpital Kliniczny Nr 2 Pomorskiej Akademii Medycznej
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Warszawa, Polen, 04-414
- Wojskowy Instytut Medyczny, Centralny Szpital Kliniczny MON
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Warszawa, Polen, 04-628
- Instytut Kardiologii im. Prymasa Tysiclecia Stefana Kardynała Wyszyńskiego
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Wroclaw, Polen, 50-369
- Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
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Wroclaw, Polen, 50-981
- 4 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ, Centrum Chorób Serca
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Zabrze, Polen, 41-800
- Śląskie Centrum Chorób Serca
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Aachen, Tyskland, 52074
- Universitaetsklinikum Aachen AOeR
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Augsburg, Tyskland, 86156
- Klinikum Augsburg
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Bad Bevensen, Tyskland, 29549
- Herz- und Gefaesszentrum Bad Bevensen
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Bonn, Tyskland, 53105
- Universitaetsklinikum Bonn
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Cologne, Tyskland, 50937
- Klinik und Poliklinik fuer Herz- und Thoraxchirurgie der Universitaet zu Koeln
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Dortmund, Tyskland, 44137
- St. Johannes Hospital
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Dresden, Tyskland, 01307
- Herzzentrum Dresden GmbH Universitaetsklinik
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Erlangen, Tyskland, 91054
- Universitaetsklinikum Erlangen
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Frankfurt, Tyskland, 60590
- Universitaetsklinikum Frankfurt
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Freiburg, Tyskland, 79106
- Universitaetsklinikum Freiburg
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Goettingen, Tyskland, 37075
- Universitaetsmedizin Goettingen
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Halle, Tyskland, 06120
- Universitaetsklinikum Halle (Saale)
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Hamburg, Tyskland, 20246
- Universitaeres Herzzentrum Hamburg GmbH
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Heidelberg, Tyskland, 69120
- Universitaetsklinikum Heidelberg
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Leipzig, Tyskland, 04289
- Herzzentrum Leipzig GmbH
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Ludwigshafen, Tyskland, 67063
- Klinikum der Stadt Ludwigshafen gGmbH
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Luebeck, Tyskland, 23538
- Klinik fuer Herzchirurgie des Universitaetsklinikum SH
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Munich, Tyskland, 80636
- Deutsches Herzzentrum Muenchen
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Wuerzburg, Tyskland, 97080
- Universitaetsklinikum Wuerzburg
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Wuppertal, Tyskland, 42117
- HELIOS Klinik Wuppertal
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 85 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Written informed consent (by study subject) prior to any study-related procedure not part of normal medical care;
- Male or female between the ages of 18 and 85 years old, inclusive; and
- Planned cardiac surgery using cardio-pulmonary bypass, for one of the following procedures: any repeat sternotomy; surgery to repair or replace more than one valve; combined CABG plus repair or replacement of at least one valve
- If female, subject is non-lactating, and is either:Not of childbearing potential, defined as postmenopausal for at least one year or surgically sterile due to bilateral tubal ligation, bilateral oophorectomy, or hysterectomy;Of childbearing potential but is not pregnant as confirmed by negative pregnancy test at time of screening (based on the β-subunit of HCG), and is practicing the barrier method of birth control along with one of the following methods: oral or parenteral contraceptives for three months prior to study drug administration, a vasectomized partner, or abstinence from sexual intercourse.
Exclusion Criteria:
- Planned primary CABG, single valve repair or replacement surgery, or any off pump procedure;
- Body weight <55 kg;
- Planned hypothermia (<28ºC);
- Planned transfusion in the peri-operative or post-operative periods;
- Planned transfusion of pre-operatively donated autologous blood;
- Female subjects who are pregnant or lactating;
- Planned use of desmopressin, lysine analogs (other than study medication), atrial natriuretic hormone or recombinant activated Factor VII;
- Planned use of corticosteroids in the pump prime solution;
- Ejection fraction <30% within 90 days prior to surgery;
- Evidence of a myocardial infarction within 5 days prior to surgery;
- History of stroke or transient ischemic attack within 3 months prior to surgery;
- Hypotension or heart failure requiring the use of inotropes or mechanical devices within 24 hours prior to surgery;
- Serum creatinine >2.0 mg/dL within 48 hours prior to surgery;
- Serum hepatic enzymes (aspartate aminotransferase or alanine aminotransferase) above 2.5 times the upper limit of normal for the applicable laboratory;
- Hematocrit <32% within 48 hours prior to surgery;
- Platelet count below the normal range for the applicable laboratory within 14 days prior to surgery;
- History of, or family history of, bleeding or clotting disorder (e.g. von Willebrand's Disease, idiopathic thrombocytopenia purpura) or thrombophilia such as anti-thrombin III deficiency or Factor V Leiden mutation;
- History of heparin-induced thrombocytopenia;
- Prothrombin time (PT) and/or activated partial thromboplastin time (aPTT) >1.5 X normal range unless subject received heparin within 24 hours of test;
- Serious intercurrent illness or active infection (e.g. endocarditis, sepsis, active malignancy requiring treatment);
- Any previous exposure to ecallantide;
- Receipt of an investigational drug or device 30 days prior to participation in the current study;
- Any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the subject or would preclude the subject from successful completion of the study;
- Inability to comply with the protocol for the duration of the study;
- Known allergy to any agent expected to be used in the intra-operative or post-operative periods; and
- Administration of: Eptifibatide within 6 hours prior to surgery, Tirofiban hydrochloride within 6 hours prior to surgery, (Enoxaparin sodium or other low-molecular-weight heparin <24 hours prior to surgery), Prasugrel within 10 days prior to surgery, Clopidogrel within 3 days prior to surgery, Ticlopidine within 7 days prior to surgery, Abciximab within 5 days prior to surgery, (Bivalirudin, argatroban or lepirudin within 6 hours prior to surgery), (Fondaparinux within 72 hours prior to surgery), Chlorpromazine within 7 days prior to surgery (Prophylactic use permitted for the prevention of deep vein thrombosis.)
- Planned use of heparin bonded bypass circuits;
- Known allergy or hypersensitivity to tranexamic acid or any of the other ingredients;
- Disturbance of color sense;
- Evidence of hematuria or any acute thromboses or thromboembolic diseases such as deep vein thrombosis, pulmonary embolism, or vertebral vein thrombosis.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: ecallantide
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2.25 mg/L pump prime, 0.13 mg/kg loading dose, 2.25 mg/L constant infusion
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Aktiv komparator: Cyklokapron(R)
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1000-mg loading dose followed by a continuous infusion of 400 mg/hr with an additional 500 mg added to the pump prime
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Cumulative Volume of Packed Red Blood Cells Transfused
Tidsramme: 12 hours after the end of surgery
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12 hours after the end of surgery
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Treatment-emergent Adverse Events.
Tidsramme: Over the duration of the study.
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Over the duration of the study.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Alistair Wheeler, MD, MFPM, Cubist Pharmaceuticals LLC
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juni 2009
Primær færdiggørelse (Faktiske)
1. december 2009
Studieafslutning (Faktiske)
1. januar 2010
Datoer for studieregistrering
Først indsendt
26. april 2009
Først indsendt, der opfyldte QC-kriterier
26. april 2009
Først opslået (Skøn)
28. april 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
10. august 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. juli 2015
Sidst verificeret
1. juli 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Blødning
- Intraoperative komplikationer
- Blodtab, kirurgisk
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Agenter fra det perifere nervesystem
- Analgetika
- Sensoriske systemagenter
- Anti-inflammatoriske midler, ikke-steroide
- Analgetika, ikke-narkotisk
- Anti-inflammatoriske midler
- Antirheumatiske midler
- Fibrinmodulerende midler
- Antifibrinolytiske midler
- Hæmostatika
- Koagulanter
- Tranexaminsyre
- Ecallantide
Andre undersøgelses-id-numre
- ECAL-CCPB-08-07
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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