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AProtinin Versus Tranexamic Acid in Cardiac Surgery Patients With High-risk for Excessive Bleeding (APACHE)

2. marts 2022 opdateret af: University Hospital, Bordeaux
In this before-after multicenter study the authors tested the hypothesis that the prophylactic use of aprotinin compared to tranexamic acid could reduce the proportion of patients presenting severe perioperative bleeding.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Perioperative bleeding remains a real challenge for physicians managing cardiac surgical patients. In patients at high risk for excessive bleeding the prophylactic use of antifibrinolytics may be useful. This study propose to compare the efficacity and innocuity of aprotinin and tranexamic acid to reduce the proportion of patient presenting severe peri-operative bleeding according the Universal Definition of Perioperative Bleeding (UDPB) classification.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

693

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Frankrig
      • La Tronche, Frankrig, 38700
        • Grenoble University Hospital
      • Lyon, Frankrig, 69500
        • Lyon University Hospital
      • Montpellier, Frankrig, 34295
        • Montpellier University Hospital
      • Nantes, Frankrig, 44093
        • Nantes University Hospital
      • Paris, Frankrig, 75877
        • North Val de Seine Paris University Hospital
      • Paris, Frankrig, 75908
        • Georges Pompidou European University Hospital
      • Pessac, Frankrig, 33604
        • Bordeaux University Hospital

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

consecutive patients undergoing cardiac surgery with a high risk of hemorrhage who have received a prophylactic infusion of either tranexamic acid or aprotinin and meeting the protocol criteria between july 2017 and october 2020 in seven university hospital centers.

Beskrivelse

Inclusion Criteria:

patients undergoing cardiac on pump surgery at high risk for bleeding defined by :

  • Aorto-coronary bypasses surgery (2 or more) under dual platelet aggregation therapy (Primary or redo)
  • Heart transplant (Primary or Redo)
  • Infectious endocarditis (Primary or Redo)
  • Ascending acute aortic dissection (Primary or Redo)
  • Artificial heart / LVAD under CEC (Primary or Redo)
  • Combined surgery, Redo
  • Ascending aorta surgery, Redo

Exclusion Criteria:

  • Off pump cardiac surgery
  • Patient not meeting the inclusion criteria
  • Patient not receiving antifibrinolytic therapy
  • Patient with absolute contraindication to antifibrinolytics,
  • Patient refusing to give access to their medical chart,
  • Patient not meeting the inclusion criteria
  • Patient protected by the law, under guardianship or trusteeship,
  • Patient deprived of liberty

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
The aprotinin group,
all patients receiving a first infusion 1M KIU before surgical incision followed by a steady dose of 250 000 KIU/h with an additional dose of 1M KIU added to the cardiopulmonary bypass unit.
Andet: plejestandard
retrospektiv undersøgelse: standardbehandling
The tranexamic acid group
all patient receiving tranexamic acid following each local center standarded protocol
Andet: plejestandard
retrospektiv undersøgelse: standardbehandling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of patients with severe peri-operative bleeding
Tidsramme: day 30 after surgery
Proportion of patients with severe peri-operative bleeding defined by an UDPB (the Universal Definition of Perioperative Bleeding ) classification of 3 and 4.
day 30 after surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
distribution of patients by UDPB classification category
Tidsramme: day 30 after surgery
proportion of patients with category 0 UDPB.
day 30 after surgery
distribution of patients by UDPB classification category
Tidsramme: day 30 after surgery
proportion of patients with category 1 UDPB.
day 30 after surgery
distribution of patients by UDPB classification category
Tidsramme: day 30 after surgery
proportion of patients with category 2 UDPB.
day 30 after surgery
distribution of patients by UDPB classification category
Tidsramme: day 30 after surgery
proportion of patients with category 3 UDPB.
day 30 after surgery
distribution of patients by UDPB classification category
Tidsramme: day 30 after surgery
proportion of patients with category 4 UDPB.
day 30 after surgery
blood loss
Tidsramme: 24 hours after chest closure
post operative chest tube blood loss
24 hours after chest closure
rescue surgery for bleeding
Tidsramme: day 30 after surgery
proportion of rescue surgery for bleeding
day 30 after surgery
length of stay
Tidsramme: through intensive care unit discharge, an average of 30 days
intensive care unit length of stay
through intensive care unit discharge, an average of 30 days
length of stay
Tidsramme: through hospital discharge, an average of 30 days
hospital length of stay
through hospital discharge, an average of 30 days
KDIGO score greater than or equal to 2
Tidsramme: day 7 after surgery
acute kidney injury defined by KDIGO score greater than or equal to 2
day 7 after surgery
mechanical ventilation time
Tidsramme: through intensive care unit discharge, an average of 30 days
duration of artificial ventilation (hours)
through intensive care unit discharge, an average of 30 days
mechanical ventilation
Tidsramme: 48 hours after surgery
need to use mechanical ventilation for more than 48 hours
48 hours after surgery
need for transfusion
Tidsramme: up to 48 hours after surgery
need for labil blood products and medicinal products derived from blood
up to 48 hours after surgery
need for transfusion
Tidsramme: up to seven day after surgery
need for labil blood products and medicinal products derived from blood
up to seven day after surgery
need for vasopressors/inotropes
Tidsramme: beyond 24 hours after surgery
need for use postoperative vasopressors/inotropes for more than 24 hours
beyond 24 hours after surgery
vital status
Tidsramme: 30 days after surgery
mortality after surgery
30 days after surgery
new renal replacement therapy
Tidsramme: up to day 30 after surgery
need for renal replacement therapy
up to day 30 after surgery
short term mechanical circulatory support
Tidsramme: up to 30 day after surgery
need for short term mechanical circulatory support (extra corporeal life support, Impella TM pump, intra aortic balloon pump)
up to 30 day after surgery
myocardial infarction
Tidsramme: up to 30 day after surgery
occurrence of myocardial infarction
up to 30 day after surgery
embolic or thrombotic event
Tidsramme: up to 30 day after surgery
occurrence of embolic or thrombotic event
up to 30 day after surgery
stroke
Tidsramme: up to 30 day after surgery
occurrence of stroke
up to 30 day after surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospital, Bordeaux

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 (Faktiske)

31. marts 2021

Primær færdiggørelse (Faktiske)

31. august 2021

Studieafslutning (Faktiske)

31. august 2021

Datoer for studieregistrering

Først indsendt

10. marts 2021

Først indsendt, der opfyldte QC-kriterier

15. marts 2021

Først opslået (Faktiske)

18. marts 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. marts 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. marts 2022

Sidst verificeret

1. marts 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CHUBX 2020/67

Plan for individuelle deltagerdata (IPD)

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