BleedingABSOLUTENCT06111261
Initial Resuscitation With Albumin in Hemorrhagic Shock to Reduce Positive Fluid Balance
A study testing Albumin solution and Balanced crystalloid solution in people with Bleeding and Massive Hemorrhage, run by Seoul National University Hospital.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Bleeding, Massive Hemorrhage, Massive Transfusion Protocol
- What is being tested?
- Albumin solution and Balanced crystalloid solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2023to 15 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official 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.
Read the 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.
- Conditions
- Bleeding, Massive Hemorrhage, Massive Transfusion Protocol
- Being tested
- Albumin solution, Balanced crystalloid solution
- Keywords
- Massive transfusion protocol, Massive transfusion, Albumin
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albumin solutionDrug
200ml of 20% Human Serum Albumin
Balanced crystalloid solutionDrug
Balanced crystalloid solution
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Albumin solution |
| 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. Receives: Drug: Balanced crystalloid solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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 outcomes (9)
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
Measured: 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.
Measured: 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
Measured: 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
Measured: When mortality occurred, through study completion, an average of 4 year
7-day mortality
7-day mortality after the initiation of massive transfusion protocol
Measured: Within 7 days since the initiation of the massive transfusion protocols
28-day mortality
28-day mortality after the initiation of massive transfusion protocol
Measured: 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
Measured: 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
Measured: up to 2 days of MTP
Transfusion-related adverse event
Transfusion-related adverse event (TRALI, TACO, Anaphylaxis)
Measured: up to 2 days of MTP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start15 Nov 2023 (estimated)
- Primary completion15 Jul 2025 (estimated)
- Study completion15 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BleedingStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seung-Young Oh, Seoul National University Hospital
- Investigators
- Seung-young Oh, M.D., Study chair, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06111261
- Sponsor's protocol ID
- 2209-086-1359
- Acronym
- ABSOLUTE
- Status last verified
- Oct 2023
- First submitted
- 10 Jan 2023
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Resuscitation With Albumin in Hemorrhagic Shock to Reduce Positive Fluid Balance: A Randomized Controlled Trial (ABSOLUTE Trial)
- ClinicalTrials.gov ID
- NCT06111261
- Acronym / sponsor ID
- ABSOLUTE / 2209-086-1359
- Conditions
- Bleeding, Massive Hemorrhage, Massive Transfusion Protocol
- Keywords
- Massive transfusion protocol, Massive transfusion, Albumin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 15 Nov 2023 (estimated)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 15 Aug 2025 (estimated)
- First posted
- 1 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Albumin-massive transfusion protocol | Experimental | Drug: Albumin solutionAt 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 | Drug: Balanced crystalloid solutionAt 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Albumin solution200ml of 20% Human Serum Albumin | Drug | Albumin-massive transfusion protocol |
| Balanced crystalloid solutionBalanced crystalloid solution | Drug | Conventional-massive transfusion protocol |
Primary outcome
Total fluid balance until physical hemostasis of bleeding is confirmed (ml)
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 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)
9 secondary outcomes
Time from the initiation of massive transfusion protocol to reversal of shock (min)
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)
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)
Time frame: When discharge from ICU or hospital for any cause (days), through study completion, an average of 4 year
In-hospital mortality
Time frame: When mortality occurred, through study completion, an average of 4 year
7-day mortality
Time frame: Within 7 days since the initiation of the massive transfusion protocols
28-day mortality
Time frame: Within 28 days since the initiation of the massive transfusion protocols
Acute kidney injury within 2 days of massive transfusion
Time frame: up to 2 days of MTP
Major pulmonary complication within 2 days of massive transfusion
Time frame: up to 2 days of MTP
Transfusion-related adverse event
Time frame: up to 2 days of MTP
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Bleeding
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seung-young Oh, M.D. study chair
Seoul National University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Albumin solution and Balanced crystalloid solution in people with Bleeding and Massive Hemorrhage, run by Seoul National University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leerang Lim, M.D. (+82-2-2072-2467, erange@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total fluid balance until physical hemostasis of bleeding is confirmed (ml) (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.