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This study is designed to evaluate the effect of early albumin transfusion within massive transfusion protocol on fluid balance and reduced requirement of transfusion.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Albumin-massive transfusion protocol | Experimental | At the initiation of MTP, 200ml of 20% albumin will be infused followed by transfusion of packed RBC:FFP:Platelet concentrate with ratio of 1:1:1. |
|
| Conventional-massive transfusion protocol | Active Comparator | At the initiation of MTP, Balanced crystalloid will be infused followed by transfusion of packed RBC:FFP:Platelet concentrate with ratio of 1:1:1. Albumin will be transfused according to the serum albumin level. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albumin solution | Drug | 200ml of 20% Human Serum Albumin |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Leerang Lim, M.D. | Contact | +82-2-2072-2467 | erange@snu.ac.kr | |
| Seung-young Oh, M.D. | Contact | +82-2-2072-2966 | faun1224@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Seung-young Oh, M.D. | Seoul National University Hospital | Study Chair |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Balanced crystalloid solution |
| Drug |
Balanced crystalloid solution |
|
| 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 |
| 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 |
| In-hospital mortality | Mortality occurred during hospital stay | When mortality occurred, through study completion, an average of 4 year |
| 7-day mortality | 7-day mortality after the initiation of massive transfusion protocol | Within 7 days since the initiation of the massive transfusion protocols |
| 28-day mortality | 28-day mortality after the initiation of massive transfusion protocol | Within 28 days since the initiation of the massive transfusion protocols |
| 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 |
| 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 |
| Transfusion-related adverse event | Transfusion-related adverse event (TRALI, TACO, Anaphylaxis) | up to 2 days of MTP |