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

Bleeding Clinical Trial

— ABSOLUTE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06111261
• Other study ID #: 2209-086-1359
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: August 15, 2025

Study information

• Verified date: October 2023
• Source: Seoul National University Hospital
• Contact: Leerang Lim, M.D.
• Phone: +82-2-2072-2467
• Email: erange[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: August 15, 2025
• Est. primary completion date: July 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bleeding
• Hemorrhage
• Massive Hemorrhage
• Shock, Hemorrhagic

Intervention

Drug:
• Albumin solution
200ml of 20% Human Serum Albumin
• Balanced crystalloid solution
Balanced crystalloid solution

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	In-hospital mortality	Mortality occurred during hospital stay	When mortality occurred, through study completion, an average of 4 year
Secondary	7-day mortality	7-day mortality after the initiation of massive transfusion protocol	Within 7 days since the initiation of the massive transfusion protocols
Secondary	28-day mortality	28-day mortality after the initiation of massive transfusion protocol	Within 28 days since the initiation of the massive transfusion protocols
Secondary	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
Secondary	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
Secondary	Transfusion-related adverse event	Transfusion-related adverse event (TRALI, TACO, Anaphylaxis)	up to 2 days of MTP