Clinical trial NCT06111261: Initial Resuscitation With Albumin in Hemorrhagic Shock to Reduce Positive Fluid Balance
Official title: Initial Resuscitation With Albumin in Hemorrhagic Shock to Reduce Positive Fluid Balance: A Randomized Controlled Trial (ABSOLUTE Trial)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bleeding
Massive Hemorrhage
Massive Transfusion Protocol
Keywords: Massive transfusion protocol
Massive transfusion
Albumin
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2023-11-01
Enrollment: 36
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total fluid balance until physical hemostasis of bleeding is confirmed (ml)
timeFrame: 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:
measure: Time from the initiation of massive transfusion protocol to reversal of shock (min)
timeFrame: 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
measure: Total amount of fluid until physical hemostasis of bleeding is confirmed (ml)
timeFrame: 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
measure: Total length of ICU and hospital stay (days)
timeFrame: When discharge from ICU or hospital for any cause (days), through study completion, an average of 4 year
measure: In-hospital mortality
timeFrame: When mortality occurred, through study completion, an average of 4 year
measure: 7-day mortality
timeFrame: Within 7 days since the initiation of the massive transfusion protocols
measure: 28-day mortality
timeFrame: Within 28 days since the initiation of the massive transfusion protocols
measure: Acute kidney injury within 2 days of massive transfusion
timeFrame: up to 2 days of MTP
measure: Major pulmonary complication within 2 days of massive transfusion
timeFrame: up to 2 days of MTP
measure: Transfusion-related adverse event
timeFrame: up to 2 days of MTP
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Hospital
name: Seung-young Oh, M.D.
role: STUDY_CHAIR
References: