AProtinin Versus Tranexamic Acid in Cardiac Surgery Patients With High-risk for Excessive Bleeding (APACHE)
2 mars 2022 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Faktisk)
693
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
La Tronche, Frankrike, 38700
- Grenoble University Hospital
-
Lyon, Frankrike, 69500
- Lyon University Hospital
-
Montpellier, Frankrike, 34295
- Montpellier University Hospital
-
Nantes, Frankrike, 44093
- Nantes university hospital
-
Paris, Frankrike, 75877
- North Val de Seine Paris University Hospital
-
Paris, Frankrike, 75908
- Georges Pompidou European University Hospital
-
Pessac, Frankrike, 33604
- Bordeaux University Hospital
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Sannolikhetsprov
Studera befolkning
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.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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.
|
retrospektiv studie: vårdstandard
|
|
The tranexamic acid group
all patient receiving tranexamic acid following each local center standarded protocol
|
retrospektiv studie: vårdstandard
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Proportion of patients with severe peri-operative bleeding
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
distribution of patients by UDPB classification category
Tidsram: day 30 after surgery
|
proportion of patients with category 0 UDPB.
|
day 30 after surgery
|
|
distribution of patients by UDPB classification category
Tidsram: day 30 after surgery
|
proportion of patients with category 1 UDPB.
|
day 30 after surgery
|
|
distribution of patients by UDPB classification category
Tidsram: day 30 after surgery
|
proportion of patients with category 2 UDPB.
|
day 30 after surgery
|
|
distribution of patients by UDPB classification category
Tidsram: day 30 after surgery
|
proportion of patients with category 3 UDPB.
|
day 30 after surgery
|
|
distribution of patients by UDPB classification category
Tidsram: day 30 after surgery
|
proportion of patients with category 4 UDPB.
|
day 30 after surgery
|
|
blood loss
Tidsram: 24 hours after chest closure
|
post operative chest tube blood loss
|
24 hours after chest closure
|
|
rescue surgery for bleeding
Tidsram: day 30 after surgery
|
proportion of rescue surgery for bleeding
|
day 30 after surgery
|
|
length of stay
Tidsram: 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
Tidsram: 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
Tidsram: day 7 after surgery
|
acute kidney injury defined by KDIGO score greater than or equal to 2
|
day 7 after surgery
|
|
mechanical ventilation time
Tidsram: 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
Tidsram: 48 hours after surgery
|
need to use mechanical ventilation for more than 48 hours
|
48 hours after surgery
|
|
need for transfusion
Tidsram: 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
Tidsram: 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
Tidsram: beyond 24 hours after surgery
|
need for use postoperative vasopressors/inotropes for more than 24 hours
|
beyond 24 hours after surgery
|
|
vital status
Tidsram: 30 days after surgery
|
mortality after surgery
|
30 days after surgery
|
|
new renal replacement therapy
Tidsram: up to day 30 after surgery
|
need for renal replacement therapy
|
up to day 30 after surgery
|
|
short term mechanical circulatory support
Tidsram: 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
Tidsram: up to 30 day after surgery
|
occurrence of myocardial infarction
|
up to 30 day after surgery
|
|
embolic or thrombotic event
Tidsram: up to 30 day after surgery
|
occurrence of embolic or thrombotic event
|
up to 30 day after surgery
|
|
stroke
Tidsram: up to 30 day after surgery
|
occurrence of stroke
|
up to 30 day after surgery
|
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
31 mars 2021
Primärt slutförande (Faktisk)
31 augusti 2021
Avslutad studie (Faktisk)
31 augusti 2021
Studieregistreringsdatum
Först inskickad
10 mars 2021
Först inskickad som uppfyllde QC-kriterierna
15 mars 2021
Första postat (Faktisk)
18 mars 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
3 mars 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
2 mars 2022
Senast verifierad
1 mars 2022
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CHUBX 2020/67
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