Initial Resuscitation With Albumin in Hemorrhagic Shock to Reduce Positive Fluid Balance

Study Overview
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Brief Summary
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This study is designed to evaluate the effect of early albumin transfusion within massive transfusion protocol on fluid balance and reduced requirement of transfusion.

Detailed Description
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Eligible patients who require massive transfusion will be randomized in a single-blind manner (participant) in a 1:1 ratio to Conventional Massive Transfusion Pro. tocol group (C-MTP) or Albumin Massive Transfusion Protocol group (A-MTP). When MTP is initiated according to the result of randomization, all patients(or a legal guardian) are informed about the study and potential risks and benefits. Study will be continued only in patients who give informed consent.

Official Title
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Initial Resuscitation With Albumin in Hemorrhagic Shock to Reduce Positive Fluid Balance: A Randomized Controlled Trial (ABSOLUTE Trial)

Conditions
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Bleeding, Massive Hemorrhage, Massive Transfusion Protocol

Intervention / Treatment
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* Drug: Albumin solution
* Drug: Balanced crystalloid solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients (19 or older) Admitted or planned to admit surgical intensive care unit Patients with decreased hemoglobin level more than 20% from baseline within 12 hours, Or Patients who are suspected bleeding and hemodynamically unstable requiring more than 0.05mcg/kg/min of norepinephrine infusion to maintain mean blood pressure higher than 65mmHg Exclusion Criteria: Contraindicated to albumin product patients with risk factors of increased circulatory volume (heart failure, pulmonary edema, end-stage renal disease with oliguria) patients with hemolytic anemia History of anaphylactic reaction to blood product

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Albumin-massive transfusion protocol<br>At the initiation of MTP, 200ml of 20% albumin will be infused followed by transfusion of packed RBC:FFP:Platelet concentrate with ratio of 1:1:1. | Drug: Albumin solution<br>* 200ml of 20% Human Serum Albumin<br>|
| Active Comparator: Conventional-massive transfusion protocol<br>At the initiation of MTP, Balanced crystalloid will be infused followed by transfusion of packed RBC:FFP:Platelet concentrate with ratio of 1:1:1. Albumin will be transfused according to the serum albumin level. | Drug: Balanced crystalloid solution<br>* Balanced crystalloid solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total fluid balance until physical hemostasis of bleeding is confirmed (ml) | Total fluid balance (Total fluid infused - Total output(urine output, bleeding, drainage, or etc.) until physical hemostasis of bleeding is confirmed (e.g. embolization, surgical exploration and ligation of vessel) | Time from the initiation of massive transfusion protocol to physical hemostasis of bleeding was confirmed, up to 48 hours after initiation of massive transfusion protocol | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from the initiation of massive transfusion protocol to reversal of shock (min) | Total time required to maintain mean blood pressure higher than 65mmHg without vasopressor | Time from the initiation of massive transfusion protocol to mean blood pressure was maintained higher than 65mmHg without vasopressor (min), up to 48 hours after initiation of massive transfusion protocol | 
| Total amount of fluid until physical hemostasis of bleeding is confirmed (ml) | Total amount of transfusion and infusion of albumin product and crystalloid. | Time from the initiation of massive transfusion protocol to physical hemostasis of bleeding was confirmed, up to 48 hours after initiation of massive transfusion protocol | 
| Total length of ICU and hospital stay (days) | Total length of ICU and hospital stay | When discharge from ICU or hospital for any cause (days), through study completion, an average of 4 year | 
| In-hospital mortality | Mortality occurred during hospital stay | When mortality occurred, through study completion, an average of 4 year | 
| 7-day mortality | 7-day mortality after the initiation of massive transfusion protocol | Within 7 days since the initiation of the massive transfusion protocols | 
| 28-day mortality | 28-day mortality after the initiation of massive transfusion protocol | Within 28 days since the initiation of the massive transfusion protocols | 
| Acute kidney injury within 2 days of massive transfusion | Incidence of Acute kidney injury (KidneyDisease:ImprovingGlobalOutcomes (KDIGO) stage 1 or above) within 2 days of massive transfusion | up to 2 days of MTP | 
| Major pulmonary complication within 2 days of massive transfusion | Major pulmonary complication(Pneumonia, PaO2/FiO2 ratio<300, pulmonary edema and pleural effusion) within 2 days of massive transfusion | up to 2 days of MTP | 
| Transfusion-related adverse event | Transfusion-related adverse event (TRALI, TACO, Anaphylaxis) | up to 2 days of MTP | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Massive transfusion protocol, Massive transfusion, Albumin