An interventional study of Albumin solution and Balanced crystalloid solution in Bleeding, Massive Hemorrhage and Massive Transfusion Protocol, sponsored by Seoul National University Hospital. Status unknown. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2023-11-01.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Treatment
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.
3,011 studies on the registry are indexed under Hemorrhage; 466 are open to participants now.
This study's planned enrollment of 36 is below the median of 100 across 1,990 interventional studies indexed under Hemorrhage.
Browse Hemorrhage studies →Seoul National University Hospital is the lead sponsor of 1,897 studies on the registry; 273 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Drug: Albumin solution
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.
Drug: Balanced crystalloid solution
200ml of 20% Human Serum Albumin
Balanced crystalloid solution
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 frame: 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
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 frame: 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 amount of fluid until physical hemostasis of bleeding is confirmed (ml)
Total amount of transfusion and infusion of albumin product and crystalloid.
Time frame: 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
Time frame: 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
Time frame: When mortality occurred, through study completion, an average of 4 year
7-day mortality
7-day mortality after the initiation of massive transfusion protocol
Time frame: Within 7 days since the initiation of the massive transfusion protocols
28-day mortality
28-day mortality after the initiation of massive transfusion protocol
Time frame: 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
Time frame: 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
Time frame: up to 2 days of MTP
Transfusion-related adverse event
Transfusion-related adverse event (TRALI, TACO, Anaphylaxis)
Time frame: up to 2 days of MTP
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2023; primary completion for Jul 2025, 20 months later.
Of 457 non-industry interventional studies with no phase under Hemorrhage, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 40. This study's planned 20 months is close to that.
Counting every sponsor, half of 522 studies reached it within 20 months; a quarter within 10 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Albumins
Seoul National University Hospital →