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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06111261
Other study ID # 2209-086-1359
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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