UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038322 |
|---|---|
| Receipt number | R000043679 |
| Scientific Title | Effect of continuing anticoagulants and antiplatelet drugs on perioperative total blood loss in total hip replacement: a prospective observational study |
| Date of disclosure of the study information | 2019/10/18 |
| Last modified on | 2019/10/17 19:03:38 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of continuing anticoagulants and antiplatelet drugs on perioperative total blood loss in total hip replacement: a prospective observational study
Acronym
Effect of continuing anticoagulants and antiplatelet drugs on perioperative total blood loss in total hip replacement: a prospective observational study
Scientific Title
Effect of continuing anticoagulants and antiplatelet drugs on perioperative total blood loss in total hip replacement: a prospective observational study
Scientific Title:Acronym
Effect of continuing anticoagulants and antiplatelet drugs on perioperative total blood loss in total hip replacement: a prospective observational study
Region
| Japan |
Condition
Condition
Osteoarthritis of the hip, rheumatoid arthritis, avascular necrosis of the femoral head
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigated the impact of continuing anticoagulants or antiplatelet drugs on perioperative blood loss in total hip arthroplasty.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The volume of perioperative blood loss measured using the calculated blood volume and change in hemoglobin from preoperative to postoperative day 4.
Key secondary outcomes
Complication
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
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
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing total hip arthroplasty
Key exclusion criteria
Patients scheduled for revision total hip arthroplasty.
Patients scheduled for total hip arthroplasty with shortening subtrochanteric osteotomy.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Kurosaka |
Organization
Hokusuikai Kinen Hospital
Division name
Orthopaedic surgery
Zip code
310-0035
Address
3-2-1 Higashihara, Mito, Ibaraki, Japan
TEL
029-303-3003
kenjikurosaka@yahoo.co.jp
Public contact
Name of contact person
| 1st name | kenji |
| Middle name | |
| Last name | Kurosaka |
Organization
Hokusuikai Kinen Hospital
Division name
Orthopaedic surgery
Zip code
310-0035
Address
3-2-1 Higashihara, Mito, Ibaraki, Japan
TEL
029-303-3003
Homepage URL
kenjikurosaka@yahoo.co.jp
Sponsor or person
Institute
Hokusuikai Kinen Hospital
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
Hokusuikai Kinen Hospital
Address
3-2-1 Higashihara, Mito, Ibaraki, Japan
Tel
029-303-3003
kenjikurosaka@yahoo.co.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
北水会記念病院 茨城県
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 18 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
perioperative total blood loss
Complication
Management information
Registered date
| 2019 | Year | 10 | Month | 17 | Day |
Last modified on
| 2019 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043679
