UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000021991 |
|---|---|
| Receipt number | R000025303 |
| Scientific Title | The effect and proper dose of unfractionated heparin after digital replantation: a prospective study |
| Date of disclosure of the study information | 2016/04/21 |
| Last modified on | 2018/05/29 14:35:48 |
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Basic information
Public title
The effect and proper dose of unfractionated heparin after digital replantation: a prospective study
Acronym
The unfractionated heparin administration after digital replantation: a prospective study
Scientific Title
The effect and proper dose of unfractionated heparin after digital replantation: a prospective study
Scientific Title:Acronym
The unfractionated heparin administration after digital replantation: a prospective study
Region
| Japan |
Condition
Condition
Digital amputations
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of the effect and proper dose of unfractionated heparin (UFH) after digital replantation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of the success rate at 2 weeks after replantation of amputated digits
Key secondary outcomes
Evaluation of the partial success rate, severity of anemia, blood transfusion volume when needed, and presence or absence of infection.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group 1 is defined by UFH 0 units per day. Pre-observation period is defined as from the first outpatient consultation to completion of surgery. The onset of the study is defined to be the time of replantation of the digit with anastomosis of the vein. The follow-up period is approximately one month after surgery. The minimum and the maximum periods are defined as 2 weeks and 2 months, respectively, for all examination items. The observation period is defined in the same manner. Continuous intravenous infusion of prostaglandin preparation for 7 days at the rate of 120yg/day, postoperatively. Each item is evaluated three times by blood test at 6 hours, 3 days, and 7 days, postoperatively. Additional treatments are promptly planned and conducted when considered necessary. The best conceivable prevention, diagnosis, and treatment are to be offered, considering the results of this study. Hemoglobin is controlled to be 10 mg/dL or higher, postoperatively. UFH administration is suspended only when anemia is difficult to control, although UFH administration is to be continued for cases where blood transfusion is effective in improving the condition. When presence of infection is suspected, culture of the wound is to be immediately submitted, and appropriate antibiotics (first generation cephem) are administered, considering the epidermal normal bacteria flora as pathogenic bacteria (causative organisms).
Interventions/Control_2
Group 2 is defined by UFH 10,000 units per day. Continuous intravenous drip infusion of UFH is started from soon after surgery. The dose period is 7 days. Each item is evaluated three times by blood test at 6 hours, 3 days, and 7 days, postoperatively.Continuous intravenous infusion of prostaglandin preparation for 7 days at the rate of 120yg/day, postoperatively.
Interventions/Control_3
Group 3 is defined by UFH 15,000 units per day. Continuous intravenous drip infusion of UFH is started from soon after surgery. The dose period is 7 days. Each item is evaluated three times by blood test at 6 hours, 3 days, and 7 days, postoperatively. In Group 3, dosage of UFH is adjusted, and APTT is controlled to be 1.5 to 2.5-fold that of preoperative levels. Continuous intravenous infusion of prostaglandin preparation for 7 days at the rate of 120yg/day, postoperatively.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients who have an amputated digit together with abnormal blood flow and seek replantation of the digit.
2)Patients who have undergone intraoperative anastomosis of the vein.
3)Patients who voluntarily give written consent to their participation in this study (or consent by the patient's family) after explanation and understanding of the study.
Key exclusion criteria
1) Patients who decide to withdraw their consent to participate.
2) Patients who have a history of hypersensitivity to UFH component.
3) Patients who have a history of thrombocytopenia caused by heparin.
4) are currently receiving oral administration of anticoagulants or anti-platelet agents.
5) Patients who have a history of blood diseases (such as idiopathic thrombocytopenic purpura.)
6) Patients who have severe hepatic diseases (with AST or ALT levels of 100 U/L or higher).
7) Patients who have severe renal disease (with BUN levels of 25 mg/dL or higher, or serum creatinine levels of 2.0 mg/dL or higher).
8) Patients who are pregnant or lactating.
Target sample size
165
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | AKIO NISHIJIMA |
Organization
New Tokyo Hospital
Division name
Department of Plastic and Reconstructive Surgery
Zip code
Address
1271 Wanagaya, Matsudo City, Chiba 270-2232, Japan
TEL
0477118700
handbal1016@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | AKIO NISHIJIMA |
Organization
New Tokyo Hospital
Division name
Department of Plastic and Reconstructive Surgery
Zip code
Address
1271 Wanagaya, Matsudo City, Chiba 270-2232, Japan
TEL
0477118700
Homepage URL
handbal1016@yahoo.co.jp
Sponsor or person
Institute
New Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
No
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
University of Tsukuba Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
新東京病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 21 | 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
Completed
Date of protocol fixation
| 2015 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 29 | Day |
Date of closure to data entry
| 2018 | Year | 05 | Month | 29 | Day |
Date trial data considered complete
| 2018 | Year | 05 | Month | 29 | Day |
Date analysis concluded
| 2018 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 19 | Day |
Last modified on
| 2018 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025303
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