Bleeding Clinical Trial
— ABSOLUTEOfficial title:
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital |
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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