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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Bleeding; Massive Hemorrhage; Massive Transfusion Protocol
• Intervention / Treatment: Drug: Albumin solution; Drug: Balanced crystalloid solution

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 Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Leerang Lim, M.D.; Phone Number: +82-2-2072-2467; Email: erange@snu.ac.kr
• Study Contact Backup: Name: Seung-young Oh, M.D.; Phone Number: +82-2-2072-2966; Email: faun1224@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Albumin-massive transfusion protocol; 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; 200ml of 20% Human Serum Albumin
Active Comparator: Conventional-massive transfusion protocol; 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; Balanced crystalloid solution

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Study Chair: Seung-young Oh, M.D., Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): November 15, 2023
• Primary Completion (Estimated): July 15, 2025
• Study Completion (Estimated): August 15, 2025

Study Registration Dates

• First Submitted: January 10, 2023
• First Submitted That Met QC Criteria: October 30, 2023
• First Posted (Actual): November 1, 2023

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Albumin; Massive transfusion; Massive transfusion protocol
• Additional Relevant MeSH Terms: Pathologic Processes; Shock; Hemorrhage; Shock, Hemorrhagic; Pharmaceutical Solutions
• Other Study ID Numbers: 2209-086-1359

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No