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

Not Applicable

Not yet recruiting

• Conditions: Bleeding; Massive Hemorrhage; Massive Transfusion Protocol
• Interventions: Drug: Albumin solution; Drug: Balanced crystalloid solution

• Registration Number: NCT06111261
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-01-10
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-30
• Last Update Submitted: 2023-10-30
• Study First Posted: 2023-11-01
• Last Update Posted: 2023-11-01
• Study Start: 2023-11-15
• Primary Completion: 2025-07-15
• Study Completion: 2025-08-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Albumin-massive transfusion protocol	Albumin solution	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.
Conventional-massive transfusion protocol	Balanced crystalloid solution	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.

Primary Outcome Measures

Name	Time	Method
Total fluid balance until physical hemostasis of bleeding is confirmed (ml)	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 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)

Secondary Outcome Measures

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