Effects of Platelet Mimicking Nanoparticles in Patients With Cirrhosis (HEMCITAP)
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ClinicalTrials.gov Identifier: NCT06050993 |
Recruitment Status :
Not yet recruiting
First Posted : September 22, 2023
Last Update Posted : September 22, 2023
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Condition or disease | Intervention/treatment |
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Liver Cirrhosis | Other: Additional blood sampling at the same time and in addition of samplings already done for the patient's standard of care. |
Study Type : | Observational |
Estimated Enrollment : | 60 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | Exploration of Primary Haemostasis in Cirrhotic Patients With T-TAS System and Effects of Platelets Mimicking Nanoparticles |
Estimated Study Start Date : | October 15, 2023 |
Estimated Primary Completion Date : | April 15, 2024 |
Estimated Study Completion Date : | April 15, 2024 |
Group/Cohort | Intervention/treatment |
---|---|
Cirrhotic patients
Patients known to have a cirrhosis, with an invasive procedure scheduled at the Paul Brousse hospital
|
Other: Additional blood sampling at the same time and in addition of samplings already done for the patient's standard of care.
During the preoperative procedure scheduled at the Paul Brousse hospital, 3 additional blood tubes (total volume 12 ml) will be withdrawn in addition of samplings already done for the patient's standard of care. |
Non-cirrhotic patients
Patients without cirrhosis, with an invasive procedure scheduled at the Paul Brousse hospital
|
Other: Additional blood sampling at the same time and in addition of samplings already done for the patient's standard of care.
During the preoperative procedure scheduled at the Paul Brousse hospital, 3 additional blood tubes (total volume 12 ml) will be withdrawn in addition of samplings already done for the patient's standard of care. |
- Area under the curve at 10 min of the T-TAS® 01 perfusion in PL chips [ Time Frame: One day ]
- Time to reach a pressure of 10 kPa above baseline [ Time Frame: One day ]
- Time to reach a pressure of 60 kPa above baseline [ Time Frame: One day ]
- Correlations between laboratory results and perfusions' characteristics [ Time Frame: Through study completion, an average of 6 months ]
Biospecimen Retention: Samples Without DNA
2 additional citrate tubes (total volume : 9 ml) and 1 Benzylsulfonyl-D-Arg-Pro-4-amidinobenzylamide (BAPA) tube (total volume : 3 ml) will be withdrawn at the same time and in addition of those already withdrawn for the patient's standard of care.
Plasma aliquots will be done from citrate tubes and frozen. Whole blood tube will be used on the same day of sampling.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Adult patients who are beneficiaries of a social security scheme or beneficiaries entitled to it
- Patients followed for a cirrhotic pathology at the Paul Brousse hospital and benefiting from a scheduled anaesthesia consultation for a scheduled interventional or surgical procedure
- For non-cirrhotic patients: adult patients who are beneficiaries of a social security scheme or beneficiaries entitled to it, benefiting from a blood test scheduled as part of their usual preoperative care (patients in the hepatology or digestive surgery department operated on at the Paul Brousse hospital)
Exclusion Criteria:
- Patient not wishing to participate in the study
- Patient with a known haemostasis abnormality other than cirrhosis
- Patient on long-term antiplatelet or anticoagulant therapy
- Patient who has taken a non-steroidal anti-inflammatory drug within 5 days prior to the blood test
- Patients with thrombopathy of genetic origin
- Patient on estrogenic therapy
- Patient with cancer under treatment or treated in the last 6 months
- Patient on immunosuppressive or immunomodulatory therapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06050993
France | |
Anaesthesia unit of the Hepatobiliary Center - Paul Brousse Hospital | |
Villejuif, France, 94800 | |
Contact: Stéphanie ROULLET, MD 33 (0)1 45 59 69 49 stephanie.roullet@aphp.fr | |
Contact: Cécile DENIS, MD 33 (0)1 49 59 56 05 cecile.denis@inserm.fr |
Responsible Party: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT06050993 |
Other Study ID Numbers: |
APHP230249 2023 -A00064-41 ( Other Identifier: IDRCB ) |
First Posted: | September 22, 2023 Key Record Dates |
Last Update Posted: | September 22, 2023 |
Last Verified: | July 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Hemostatics Blood Coagulation Disorders Liver Cirrhosis Platelet Adhesiveness |
Liver Cirrhosis Fibrosis Pathologic Processes Liver Diseases Digestive System Diseases |