Målrettet hæmostatisk genoplivningsforsøg i ACLF-induceret koagulopati (GOODHEART-ACLF)
Tromboelastometri guidet transfusionsprotokol versus standardbehandling ved akut-på-kronisk leversvigt med blødning: et prospektivt interventionsforsøg
In this project, we plan to evaluate whether a new, rotational thromboelastometry-guided algorithm (ROTEM) to guide hemostatic resuscitation decreases the use of allogeneic blood products, the total amount of bleeding, transfusion related side effects, thromboembolic complications and costs. Its effect on each patient's post-operative hemostatic profile is also measured.
We plan to enroll 260 patients having ACLF with variceal bleeding randomized into two groups: one will be treated conventionally using clinical judgement and standard coagulation tests such as prothrombin time, platelet count, etc. the other treated using a ROTEM-based algorithm. They will be followed for development of rebleeding, complications of transfusion and any signs of infection after hospitalization
There will be a 'no intervention' group with well controlled bleeding who will undergo VETs but not be offered coagulation correction prophylactically in accordance with the Baveno VII consensus. This control group will be followed up in parallel with the main intervention groups.
The ROTEM or SCT based correction will only be offered to patients who have high risk for rebleeding/ failure to control bleeding/ active bleeding at endoscopy/ need SEMS/TIPS and such individuals will be randomized to 2 arms ROTEM vs SCT, with 130 in each arm.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Patients with acute-on-chronic liver failure (ACLF) have coagulation failure in the setting of systemic inflammatory syndrome (SIRS), sepsis and extra-hepatic organ failures. The utility of thromboelastography/thromboelastometry currently has unvalidated clinical benefit in the assessment and reversal of coagulopathy among cirrhotic patients as compared to standard coagulation testing.Need for periprocedural blood transfusion is still high in patients with decompensated cirrhosis or ACLF who present with major bleeding. Allogeneic blood transfusion may be detrimental in patients with cirrhosis, due to volume overload and acute lung injury. Viscoelastic testing of global coagulation such as thromboelastometry has been proposed as a superior tool to rapidly diagnose and help guide resuscitation with blood products. In prior studies, we have clarified the pathophysiology of hemostasis in relation to the evidence of sepsis in liver disease and described the accuracy of various available laboratory tests in assessment of these patients. We have described the role of endogenous heparinoids in severe alcoholic hepatitis and the pathogenesis of the coagulation defect in ACLF. We determined the influence of sepsis on coagulation disorders in ACLF patients, to correctly identify the type and optimal quantity of blood product requirement in at risk patients.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Choose Any State/Province
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Chandigarh, Choose Any State/Province, Indien, 160012
- Postgraduate Institute of Medical Education and Research
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Patient with ACLF with variceal bleeding is eligible for the study if one or more of the criteria are met following primary endoscopic intervention.
- Multiple sites of bleed e.g. diffuse mucosal ooze, post EVL ulcers, diffuse portal hypertensive gastropathy, etc which are associated with coagulation dysfunction against a background of portal hypertensive bleeding
- Failure to control bleeding
- Active bleeding on endoscopy with refractory variceal bleeding, need for balloon tamponade or self expandable metal stents (SEMS)
- At the time of bridge therapy to a more definite treatment such as PTFE covered TIPS.
If one of the above criteria is met, then the patient is enrolled provided they meet the criteria below.
Inclusion Criteria:
- Age 18-65 years
- ACLF, as diagnosed by CANONIC/ APASL criteria .
- Upper gastrointestinal bleeding
Exclusion Criteria:
- Current therapy: Recent blood or blood component transfusion in the last 2 weeks.
- HIV positive/ AIDS patients
- Patients requiring antiplatelet therapy,
- Renal insufficiency requiring dialysis
- Active malignancy within the last 5 years
- Patient with other neurological disease and metabolic disorders, unbalanced heart failure and/or respiratory failure or end-stage renal disease
- Administration of anticoagulants, antifibrinolytics,
- Not willing to participate in the study
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: ROTEM-arm
Treatment of significant blood loss using point-of-care testing of whole blood viscoelasticity (ROTEM) monitoring coagulopathy or hyperfibrinolysis |
ROTEM-guided protocol of hemostatic resuscitation |
|
Aktiv komparator: Control-arm
Treatment of significant blood loss conventionally, ie. using clinical judgement and conventional coagulation tests, such as prothrombin time (as international normalized ratio, INR), activated partial thrombin time (APTT), fibrinogen in plasma |
ROTEM-guided protocol of hemostatic resuscitation |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of participants with clinical control of bleeding
Tidsramme: 24 hours
|
Clinical control of bleeding at 24 hours, at Day 5 and day 42 |
24 hours
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Number of participants with clinical control of bleeding
Tidsramme: 5 days
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Clinical control of bleeding at 24 hours, at Day 5 and day 42 |
5 days
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Number of participants with clinical control of bleeding
Tidsramme: 42 days
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Clinical control of bleeding at 24 hours, at Day 5 and day 42 |
42 days
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Varighed af intensiv indlæggelse
Tidsramme: 30 dage efter blødningsepisode behandlet med transfusionsprotokol
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30 dage efter blødningsepisode behandlet med transfusionsprotokol
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Varighed af hospitalsophold
Tidsramme: 30 dage efter blødningsepisode behandlet med transfusionsprotokol
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30 dage efter blødningsepisode behandlet med transfusionsprotokol
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Antal deltagere med tromboemboliske hændelser
Tidsramme: 30 dage efter blødningsepisode behandlet med transfusionsprotokol
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30 dage efter blødningsepisode behandlet med transfusionsprotokol
|
|
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Number of Participants with Transfusion-related side effects
Tidsramme: 30 days after bleeding episode treated by transfusion protocol
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The number and type of coagulation directed blood components fresh frozen plasma, platelet concentrate, fibrinogen concentrate and cryoprecipitate and adverse events related will be assessed in either arm. |
30 days after bleeding episode treated by transfusion protocol
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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PGI/IEC/2020/000268
- PGI/IEC/2024/EIC000462 27.3.24 (Anden identifikator: PGIMER Institutional review board)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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