UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010349 |
|---|---|
| Receipt number | R000012114 |
| Scientific Title | Dalteparin, a Low Molecular Weight Heparin, as Part of Combination Therapy for Patients with Kawasaki Disease: a Retrospective and Pilot Study |
| Date of disclosure of the study information | 2013/03/29 |
| Last modified on | 2013/03/29 08:08:18 |
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Basic information
Public title
Dalteparin, a Low Molecular Weight Heparin, as Part of Combination Therapy for Patients with Kawasaki Disease: a Retrospective and Pilot Study
Acronym
Dalteparin in combination therapy for KD
Scientific Title
Dalteparin, a Low Molecular Weight Heparin, as Part of Combination Therapy for Patients with Kawasaki Disease: a Retrospective and Pilot Study
Scientific Title:Acronym
Dalteparin in combination therapy for KD
Region
| Japan |
Condition
Condition
Kawasaki disease
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We assessed whether concurrent dalteparin, which has anti- coagulant and anti-angiogenic activity, would reduce coronary artery lesion (CAL) prevalence and resistance to intravenous immunoglobulin (IVIG) therapy in KD.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
A survey of coronary artery lesion (CAL), resistance for intravenous immunoglobulin (IVIG) therapy and additional IVIG therapy was performed within one months of all patients.
Key secondary outcomes
A survey of cardiac sequelae was performed using echocardiography at follow-up, within three months of discharge of all patients.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
This retrospective study comprised two parts. Subjects with Kawasaki disease (KD) (n = 126), admitted from January 2004 to June 2008, received either dalteparin at 75 IU/kg/h, IVIG at 400 mg/kg/d for 5 d consecutively and aspirin at 30 mg/kg/d, or dalteparin at 75 IU/kg/h and aspirin at 30 mg/kg/d. Control data came from the 2005-06 nationwide KD survey. Subjects with KD (n = 112), admitted from June 2010 to February 2012, received either dalteparin at 75 IU/kg/h, IVIG 2.0 g/kg/d and aspirin at 30 mg/kg/d, or dalteparin at 75 IU/kg/h and aspirin at 30 mg/kg/d. Control data came from the 2009-10 nationwide KD survey. All of the subjects at the single institution were given dalteparin as part of their combination therapy.
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
| 0 | months-old | <= |
Age-upper limit
| 167 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
The diagnostic criteria are compliant with the Diagnostic Guidelines for Kawasaki Disease (5th revision).
Key exclusion criteria
Patients presenting with CAL before the initial treatment were also excluded from the study.
Target sample size
238
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuji Inamo |
Organization
Nihon University School of Medicine
Division name
Department of pediatrics and child health
Zip code
Address
30-1 Oyaguchi-kamimachi, Itabashi-ku, Tokyo 173-8610, Japan.
TEL
03-3972-8111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuji Inamo |
Organization
Nihon University School of Medicine
Division name
Department of pediatrics and child health
Zip code
Address
30-1 Oyaguchi-kamimachi, Itabashi-ku, Tokyo 173-8610, Japan.
TEL
03-3972-8111
Homepage URL
inamo.yasuji@nihon-u.ac.jp
Sponsor or person
Institute
Department of pediatrics and child health, Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
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
旧 日本大学医学部付属練馬光が丘病院小児総合診療科（東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | Month | 29 | 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
A comparison of the first trial with the nationwide survey, showed that the rate of initial administration of IVIG was 80.2% versus 86.0%; the rate of additional IVIG administration was 7.1% versus 14.0% (P < 0.03); the prevalence of CAL in the acute period was 4.8% versus 11.9% (P < 0.01); and the prevalence of cardiovascular sequelae was 0% versus 3.8% (P < 0.05). A comparison of the second trial with the nationwide survey, showed that the rate of initial administration of IVIG was 92.9% versus 89.5%; the rate of additional IVIG administration was 8.9% versus 17.1% (P < 0.02); the prevalence of resistance to IVIG was 3.6% versus 14.9% (P < 0.001); and the prevalence of CAL in the acute period was 2.7% versus 8.6% (P < 0.03).
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
| 2004 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 12 | Month | 20 | Day |
Date trial data considered complete
| 2012 | Year | 12 | Month | 20 | Day |
Date analysis concluded
| 2012 | Year | 12 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 29 | Day |
Last modified on
| 2013 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012114
