UMIN-ICDS Clinical Trial

Public title

A multicenter study of blood component recovery and safety-related markers when concentrating blood remaining in the heart-lung machine circuit

Acronym

Study of concentration and component recovery from blood remaining in the heart-lung machine circuit

Scientific Title

A multicenter prospective observational study of the potential for autologous blood component recovery and changes in safety-related factors following ultrafiltration of residual cardiopulmonary bypass circuit blood

Scientific Title:Acronym

Multicenter prospective observational study of ultrafiltration of residual cardiopulmonary bypass circuit blood

Region

Japan

Condition

Cardiac and great vessel diseases requiring surgery with cardiopulmonary bypass

Classification by specialty

Anesthesiology	Cardiovascular surgery	Blood transfusion

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To quantify blood components, including fibrinogen, platelets, and red blood cells, remaining in the cardiopulmonary bypass (CPB) circuit at the end of CPB, and to evaluate the extent to which these components are retained and recovered by ultrafiltration performed as part of routine care using existing CPB and ultrafiltration circuits. Changes in hemolysis-related markers and residual rocuronium concentrations and estimated total amounts before and after ultrafiltration will also be explored at participating centers and in patients for whom these measurements are feasible.

Basic objectives2

Others

Basic objectives -Others

Descriptive assessment of estimated total amounts and recovery rates of blood components before and after ultrafiltration of residual cardiopulmonary bypass circuit blood

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

The study protocol specifies three primary outcomes:
1. Estimated total fibrinogen amount (g) in residual circuit blood after completion of cardiopulmonary bypass and before ultrafiltration.
2. Estimated total fibrinogen amount (g) in residual circuit blood after completion of ultrafiltration.
3. Estimated fibrinogen recovery rate (%), calculated as the post-ultrafiltration estimated total amount divided by the pre-ultrafiltration estimated total amount, multiplied by 100.

The estimated total amount at each time point is calculated from the fibrinogen concentration and the estimated plasma volume of residual circuit blood at the same time point.

Key secondary outcomes

Hemoglobin concentration, hematocrit, platelet count, fibrinogen concentration, activated clotting time (ACT), and residual circuit blood volume are assessed before and after ultrafiltration following completion of cardiopulmonary bypass during the same operation, together with their changes. Ultrafiltrate volume, concentration ratio, and processing time are also assessed.

Where feasible, hemolysis-related markers (LDH, objective hemolysis grading, hemolysis index, plasma-free hemoglobin concentration, etc.), rocuronium concentration, and estimated total residual rocuronium amount are assessed before and after ultrafiltration, together with their changes, as exploratory outcomes. Associations with participating centers and clinical background factors are explored as appropriate.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients of any age undergoing surgery requiring cardiopulmonary bypass (CPB), including cardiac and great vessel surgery.
2. Patients with residual circuit blood after completion of CPB who undergo ultrafiltration of this blood using existing CPB and ultrafiltration circuits as part of routine care determined by the treating clinical team.
3. Patients from whom residual circuit blood samples required for the study can be obtained before and after ultrafiltration.
4. Patients who have not opted out of the use of their samples and information for this study through the opt-out procedure publicly announced at each participating center.

Key exclusion criteria

1. Patients who, or whose parents or guardians, decline the use of their samples and information for this study.
2. Patients in whom the treating clinical team does not perform ultrafiltration of residual CPB circuit blood as part of routine care because of contamination, marked clotting, or other clinical reasons.
3. Patients whose primary outcomes cannot be calculated because fibrinogen levels or residual blood volumes before or after ultrafiltration are unavailable are excluded from the primary outcome analysis. They may be included in secondary analyses when other measurements are available.
4. Patients considered unsuitable for the study by the investigators at each participating center.

Target sample size

600

Name of lead principal investigator

1st name	Tomohiro
Middle name
Last name	Yamamoto

Organization

Niigata University Graduate School of Medical and Dental Sciences

Division name

Division of Anesthesiology

Zip code

951-8510

Address

1-757 Asahimachi-dori, Chuo-ku, Niigata, Japan

TEL

2025-227-2328

Email

yamatomo@med.niigata-u.ac.jp

Name of contact person

1st name	Tomohiro
Middle name
Last name	Yamamoto

Organization

Niigata University Graduate School of Medical and Dental Sciences

Division name

Division of Anesthesiology

Zip code

951-8510

Address

1-757 Asahimachi-dori, Chuo-ku, Niigata, Japan

TEL

025-227-2328

Homepage URL

Email

yamatomo@med.niigata-u.ac.jp

Institute

Niigata University

Institute

Department

Personal name

Organization

Niigata University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ethics Committee of Niigata University

Address

1-754 Asahimachi-dori, Chuo-ku, Niigata, Japan

Tel

025-227-2625

Email

ethics@adm.niigata-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

新潟大学医歯学総合病院（日本）
KKR札幌医療センター（日本）
北海道立子ども総合医療・療育センター（日本）
埼玉医科大学国際医療センター（日本）
JCHO九州病院（日本）
済生会熊本病院（日本）
小倉記念病院（日本）
福岡市立こども病院（日本）

Date of disclosure of the study information

2026

Year

11

Month

12

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

11

Month

05

Day

Date of IRB

2026

Year

11

Month

09

Day

Anticipated trial start date

2027

Year

01

Month

01

Day

Last follow-up date

2029

Year

06

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

2029

Year

12

Month

31

Day

Other related information

This is a multicenter prospective observational study of patients undergoing ultrafiltration of residual cardiopulmonary bypass (CPB) circuit blood as part of routine care. Blood components, residual blood volume, processing conditions, and clinical information are collected before and after ultrafiltration. The treating clinical team determines whether and how to perform ultrafiltration, its endpoint, blood reinfusion, and additional protamine administration, without study-directed assignment or instructions. Samples are obtained from residual circuit blood without additional patient puncture or blood sampling for research purposes.

Adults (aged 18 years or older) and children (younger than 18 years) are analyzed separately. The minimum enrollment target is 100 patients per group, with a maximum of 300 per group and 600 overall. Enrollment in each group ends upon reaching 300 patients or by June 30, 2029. Analysis and publication for one group may proceed after its enrollment ends while enrollment in the other group continues.

Patients or their guardians are given the opportunity to decline the use of samples and information through an opt-out procedure at each participating center.

Registered date

2026

Year

11

Month

12

Day

Last modified on

2026

Year

11

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072798