UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect and proper dose of unfractionated heparin after digital replantation: a prospective study
Title of the study (Brief title)	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	AKIO NISHIJIMA
Organization	New Tokyo Hospital
Division name	Department of Plastic and Reconstructive Surgery
Address	1271 Wanagaya, Matsudo City, Chiba 270-2232, Japan
TEL	0477118700
Email	handbal1016@yahoo.co.jp

Public contact
Name of contact person	AKIO NISHIJIMA
Organization	New Tokyo Hospital
Division name	Department of Plastic and Reconstructive Surgery
Address	1271 Wanagaya, Matsudo City, Chiba 270-2232, Japan
TEL	0477118700
Homepage URL
Email	handbal1016@yahoo.co.jp

Sponsor
Institute	New Tokyo Hospital
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025303