UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062484 |
|---|---|
| Receipt number | R000071508 |
| Scientific Title | Hemostatic effect of oxidized regenerated cellulose in bipolar hemiarthroplasty |
| Date of disclosure of the study information | 2026/09/01 |
| Last modified on | 2026/08/05 19:05:55 |
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Basic information
Public title
A clinical trial evaluating whether oxidized regenerated cellulose reduces bleeding during and after bipolar hemiarthroplasty
Acronym
Evaluation of the Hemostatic Effect of ORC in BHA
Scientific Title
Hemostatic effect of oxidized regenerated cellulose in bipolar hemiarthroplasty
Scientific Title:Acronym
Evaluation of the Hemostatic Effect of ORC in BHA
Region
| Japan |
Condition
Condition
Femoral neck fracture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether the use of oxidized regenerated cellulose powder reduces perioperative blood loss compared with no use in patients undergoing bipolar hemiarthroplasty for femoral neck fracture.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Perioperative total blood loss calculated from the preoperative and postoperative day 7 hematocrit values using the estimated blood volume derived from the Nadler formula and the Gross formula. If red blood cell transfusion is administered by postoperative day 7, the transfused volume will be added to the total blood loss.
Key secondary outcomes
1.Postoperative thigh swelling assessed by comparing preoperative and postoperative CT images
2.Subcutaneous hematoma assessed using postoperative CT images
3.Postoperative pain score
4.Red blood cell transfusion rate through postoperative day 7
5.Perioperative complications and adverse events occurring before hospital discharge
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
During bipolar hemiarthroplasty, after implant placement, 3 g of oxidized regenerated cellulose powder will be applied once to bleeding sites around the joint capsule in addition to standard hemostatic procedures, followed by gauze compression for 2 minutes. After hemostasis is confirmed, excess powder will be removed as much as possible. Tranexamic acid 1 g will be administered intravenously before surgery.
Interventions/Control_2
During bipolar hemiarthroplasty, oxidized regenerated cellulose powder will not be used. Standard hemostatic procedures will be performed, followed by gauze compression for 2 minutes after implant placement. Tranexamic acid 1 g will be administered intravenously before surgery.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients aged 20 years or older
2.Patients diagnosed with femoral neck fracture
3.Patients scheduled to undergo bipolar hemiarthroplasty at Ando Hospital
4.Patients for whom written informed consent is obtained from the patient or a legally acceptable representative1.
Key exclusion criteria
1.Patients with comorbid conditions associated with an increased bleeding tendency or severe coagulation disorders
2.Patients considered unsuitable for the use of oxidized regenerated cellulose powder
3.Patients considered unsuitable for participation in this study by the principal investigator or a study investigator
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Uemura |
Organization
Osaka University Graduate School of Medicine, Osaka, Japan
Division name
Department of Orthopaedic Medical Engineering
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3271
surmountjp@gmail.com
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Uemura |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Orthopaedic Medical Engineering
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3271
Homepage URL
surmountjp@gmail.com
Sponsor or person
Institute
The University of Osaka
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Osaka Hospital Ethical Review Board
Address
2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
Tel
06-6210-8296
mailto:rinri@hp-crc.med.osaka-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
医療法人社団智聖会 安藤病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
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
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 08 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 05 | Day |
Last modified on
| 2026 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071508
