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

Seoul National University

Status: Not yet enrolling

Conditions: Massive Transfusion Protocol; Massive Hemorrhage; Bleeding

Treatments: Drug: Balanced crystalloid solution; Drug: Albumin solution

Study type: Interventional

Funder types: Other

Identifiers

NCT06111261

2209-086-1359

Details and patient eligibility

About

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

Full description

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 2 patient groups

Albumin-massive transfusion protocol

Experimental group

Description:

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.

Treatment:

Drug: Albumin solution

Conventional-massive transfusion protocol

Active Comparator group

Description:

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.

Treatment:

Drug: Balanced crystalloid solution