Bleeding, Massive Hemorrhage, Massive Transfusion Protocol
Conditions
Keywords
Massive transfusion protocol, Massive transfusion, Albumin
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.
Interventions
DRUGAlbumin solution
200ml of 20% Human Serum Albumin
Balanced crystalloid solution
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total fluid balance 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 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 amount of transfusion and infusion of albumin product and crystalloid. |
| 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 | Total length of ICU and hospital stay |
| In-hospital mortality | When mortality occurred, through study completion, an average of 4 year | Mortality occurred during hospital stay |
| 7-day mortality | Within 7 days since the initiation of the massive transfusion protocols | 7-day mortality after the initiation of massive transfusion protocol |
| 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 time required to maintain mean blood pressure higher than 65mmHg without vasopressor |
| Acute kidney injury within 2 days of massive transfusion | up to 2 days of MTP | Incidence of Acute kidney injury (KidneyDisease:ImprovingGlobalOutcomes (KDIGO) stage 1 or above) within 2 days of massive transfusion |
| Major pulmonary complication within 2 days of massive transfusion | up to 2 days of MTP | Major pulmonary complication(Pneumonia, PaO2/FiO2 ratio\<300, pulmonary edema and pleural effusion) within 2 days of massive transfusion |
| Transfusion-related adverse event | up to 2 days of MTP | Transfusion-related adverse event (TRALI, TACO, Anaphylaxis) |
| 28-day mortality | Within 28 days since the initiation of the massive transfusion protocols | 28-day mortality after the initiation of massive transfusion protocol |
Contacts
Primary ContactLeerang Lim, M.D.
Backup ContactSeung-young Oh, M.D.
Outcome results
None listed