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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000028321 |
Receipt No. | R000032399 |
Scientific Title | Evaluation of residual effect of perioperative anticoagulat and antiplatelet drugs by using Sonoclot. |
Date of disclosure of the study information | 2017/07/21 |
Last modified on | 2017/07/21 |
Basic information | ||
Public title | Evaluation of residual effect of perioperative anticoagulat and antiplatelet drugs by using Sonoclot. | |
Acronym | Evaluation of residual effect of perioperative anticoagulat and antiplatelet drugs by using Sonoclot. | |
Scientific Title | Evaluation of residual effect of perioperative anticoagulat and antiplatelet drugs by using Sonoclot. | |
Scientific Title:Acronym | Evaluation of residual effect of perioperative anticoagulat and antiplatelet drugs by using Sonoclot. | |
Region |
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Condition | |||
Condition | Patients who are given anticoagulants or antiplatelet drugs in elective operations. | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate the efficacy of Sonoclot when the residual inhibitory action of coagulation or platelet in case the anticoagulants or antiplatelet drugs are continued in elective operations. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Explanatory |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | The results of Sonoclot including activated clotting time (ACT), clot rate, platelet function. |
Key secondary outcomes | Types of anticoagulant / antiplatelet drugs, drug holiday, presence or absence of heparin substitution, disease name, operation type, bleeding volume, blood transfusion volume. |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Among patients undergoing anesthesia management by elective operation, patients who are continuing anticoagulant / antiplatelet drugs, patients who were discontinued, patients who have not been administered. | |||
Key exclusion criteria | Patients who can not obtain consent, emergency operation patients, patients with anemia, patients who have received transfusion within 2 weeks, patients with diagnosed blood / coagulation abnormality, patients with renal dysfunction, dialysis patients, hepatic dysfunction, patients who have stopped anticoagulant / antiplatelet drugs but who do not satisfy the drug holiday period specified in this study. | |||
Target sample size | 150 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Sapporo Medical University, School of Medicine
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Division name | Department of Anesthesiology | ||||||
Zip code | |||||||
Address | S.1, W.16, Chuo-ku, Sapporo, Japan | ||||||
TEL | 011-688-9663 | ||||||
yamakage@sapmed.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Sapporo Medical University, School of Medicine | ||||||
Division name | Department of Anesthesiology | ||||||
Zip code | |||||||
Address | S.1, W.16, Chuo-ku, Sapporo, Japan | ||||||
TEL | 011-688-9663 | ||||||
Homepage URL | |||||||
rygz.32417.ad@gmail.com |
Sponsor | |
Institute | Sapporo Medical University, School of Medicine, Department of Anesthesiology |
Institute | |
Department |
Funding Source | |
Organization | Sapporo Medical University, School of Medicine, Department of Anesthesiology |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization |
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 |
Other administrative information | |||||||
Date of disclosure of the study information |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | We have not started yet. |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032399 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |