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

NCT06111261 | Unknown DMC

• 1 other identifier: 2209-086-1359
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bleeding; Massive Hemorrhage; Massive Transfusion Protocol

Keywords

Massive transfusion protocol; Massive transfusion; Albumin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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 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 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

• In-hospital mortality

  When mortality occurred, through study completion, an average of 4 year

• 7-day mortality

  Within 7 days since the initiation of the massive transfusion protocols

Study Arms (2)

Albumin-massive transfusion protocol

EXPERIMENTAL

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

Conventional-massive transfusion protocol

ACTIVE COMPARATOR

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

Interventions

Albumin solution DRUG

200ml of 20% Human Serum Albumin

Albumin-massive transfusion protocol

Balanced crystalloid solution DRUG

Balanced crystalloid solution

Conventional-massive transfusion protocol

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Seung-young Oh, M.D.

  Seoul National University Hospital

  STUDY CHAIR

Central Study Contacts

Leerang Lim, M.D.

CONTACT

+82-2-2072-2467; erange@snu.ac.kr

Seung-young Oh, M.D.

CONTACT

+82-2-2072-2966; faun1224@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical associate professor

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: November 1, 2023
• Study Start: November 15, 2023
• Primary Completion: July 15, 2025
• Study Completion: August 15, 2025
• Last Updated: November 1, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share