Ensaio de Ressuscitação Hemostática Dirigido por Meta em Coagulopatia Induzida por ACLF (GOODHEART-ACLF)
Protocolo de Transfusão Guiada por Tromboelastometria Versus Cuidado Padrão na Insuficiência Hepática Crônica Aguda com Sangramento: Um Estudo de Intervenção Prospectiva
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Choose Any State/Province
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Chandigarh, Choose Any State/Province, Índia, 160012
- Postgraduate Institute of Medical Education and Research
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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 |
|
Comparador Ativo: 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 |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of participants with clinical control of bleeding
Prazo: 24 hours
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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
Prazo: 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
Prazo: 42 days
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Clinical control of bleeding at 24 hours, at Day 5 and day 42 |
42 days
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Duração da internação em terapia intensiva
Prazo: 30 dias após episódio hemorrágico tratado por protocolo transfusional
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30 dias após episódio hemorrágico tratado por protocolo transfusional
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Duração da internação
Prazo: 30 dias após episódio hemorrágico tratado por protocolo transfusional
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30 dias após episódio hemorrágico tratado por protocolo transfusional
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Número de participantes com eventos tromboembólicos
Prazo: 30 dias após episódio hemorrágico tratado por protocolo transfusional
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30 dias após episódio hemorrágico tratado por protocolo transfusional
|
|
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Number of Participants with Transfusion-related side effects
Prazo: 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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Colaboradores e Investigadores
Colaboradores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- PGI/IEC/2020/000268
- PGI/IEC/2024/EIC000462 27.3.24 (Outro identificador: PGIMER Institutional review board)
Plano para dados de participantes individuais (IPD)
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