UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052805 |
|---|---|
| Receipt number | R000060192 |
| Scientific Title | A prospective observational study on the evaluation of coagulation function of contrast medium-mixed blood using the blood coagulation analysis device TEG 6s. |
| Date of disclosure of the study information | 2023/12/01 |
| Last modified on | 2023/11/15 15:07:33 |
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Basic information
Public title
A prospective observational study on the evaluation of coagulation function of contrast medium-mixed blood using the blood coagulation analysis device TEG 6s.
Acronym
Coagulation function evaluation of contrast medium-mixed blood.
Scientific Title
A prospective observational study on the evaluation of coagulation function of contrast medium-mixed blood using the blood coagulation analysis device TEG 6s.
Scientific Title:Acronym
Coagulation function evaluation of contrast medium-mixed blood.
Region
| Japan |
Condition
Condition
Patients under general anesthesia with an arterial line inserted during surgery.
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
One of the complications of epidural or spinal anesthesia is post-dural puncture headache (PDPH). It is believed to occur due to either of the following: the leakage of cerebrospinal fluid (CSF) from the puncture point, which causes a decrease in intracranial pressure and the descent of intracranial tissue, leading to traction headache; or a decrease in CSF volume, which causes an increase in cerebral blood flow relative to CSF volume, stimulating pain receptors associated with vascular dilation.
In any case, if the headache does not improve with oral treatment, a blood patch is performed to seal the puncture site by injecting the patient's own blood collected from the puncture site and causing it to coagulate. In this case, the puncture site is clear, so it is not difficult to find the blood injection site. However, it is difficult to identify the CSF leakage site in patients with spontaneous intracranial hypotension (SIH), who present with the same condition without physical invasion such as puncture.
However, there is no research to date that has examined whether blood injected into the same area after the injection of contrast medium will coagulate properly and seal the puncture site. The purpose of this study is to verify the hemostatic coagulation ability of a mixture of blood and contrast medium using the blood coagulation analysis device TEG 6s.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The major evaluation item is to search for the coagulation ability of each specimen by mixing contrast medium and blood collected from patients in the following proportions: 0:1, 1:2, 1:1, 2:1, and 1:0.
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Based on the studies that have been conducted, SIH is thought to occur relatively early in life. Some studies have been limited to children, while others have found that the median age of patients was in their 40s. Therefore, the target age for this study will be set at under 60 years old.
Key exclusion criteria
Patients with diseases that cause abnormalities in hemostatic coagulation ability, such as protein S/C or antithrombin deficiency, patients whose fibrinogen and platelet values deviate from the reference range in preoperative blood tests, pregnant women, patients who have difficulty obtaining consent forms, and patients who refuse consent.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Yamauchi |
Organization
Tohoku University
Division name
Department of Anesthesiology and Perioperative Medicine
Zip code
980-8575
Address
2-1 Seiryomachi, Aoba-ku, Sendai, Miyagi
TEL
022-717-7321
yamauchi@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Hidehisa |
| Middle name | |
| Last name | Saito |
Organization
Tohoku University Hospital
Division name
Department of Surgery
Zip code
980-8575
Address
2-1 Seiryomachi, Aoba-ku, Sendai, Miyagi
TEL
022-717-7321
Homepage URL
hidehisa.saito.e2@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
None
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
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.ac.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 11 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study is going to be conducted on patients who undergo surgery and have an arterial pressure line inserted at Tohoku University Hospital.
After anesthesia induction, 5mL of blood samples are collected from the arterial pressure line at the same time as ACT blood sampling and blood gas analysis. After placing the blood samples in a syringe containing citrate, the contrast agent Omnipaque 240 used for fluoroscopic observation is mixed with the blood samples in ratios of 0:1, 1:2, 1:1, 2:1, and 1:0. Using the blood coagulation analysis device TEG 6s, the hemostatic coagulation ability of each sample is compared in terms of CK R, CKH R, CRT MA, CRT LY30, and CFF MA.
Management information
Registered date
| 2023 | Year | 11 | Month | 15 | Day |
Last modified on
| 2023 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060192
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