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Splenectomy; Status clinical trials

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NCT ID: NCT06025487 Not yet recruiting - Splenectomy; Status Clinical Trials

Meningococcal B Vaccine in Patients With Asplenia

Start date: October 1, 2023
Phase: Phase 2
Study type: Interventional

Patients without a spleen (asplenia) experience an increased risk for septicaemia from encapsulated bacteria, which is associated with a high mortality rate. Meningococcal bacteria can cause such infections and serogroup B is the dominant meningococcal subtype in Europe. Therefore, vaccination for risk populations like patients without a spleen is a pressing matter. Considering the effectiveness of the meningococcal serogroup B vaccine, data for this high-at-risk population is currently lacking. The aim of this study is to evaluate the meningococcal B vaccine (BEXSERO®) in patients without a spleen compared to a healthy control group. A total of 40 patients and 40 healthy persons will receive a two-dose schedule of BEXSERO® with a one-month interval between doses. The effectiveness of the vaccine will be determined by measuring antibodies against different meningococcal strains in the blood of the patient. The amount of antibodies one month after second vaccination will be compared between patients and healthy persons. The most reliable assay to determine antibodies against meningococcal strains is the human serum bactericidal assay which will be carried out in a reference laboratory. Other end points are the persistence of antibodies after six months and the cellular immune response. The cellular immune response will be assessed by measuring the proliferation of certain immune cells like lymphocytes and the amount of produced cytokines (signalling proteins) after vaccination. In addition, the safety of the vaccine will be evaluated by documenting all adverse reactions to the vaccine. Overall, this study will be the first to assess the effectiveness of the meningococcal B vaccine in this high-at-risk population and provide data for vaccination guidelines.

NCT ID: NCT05339269 Recruiting - Cirrhosis, Liver Clinical Trials

The Effect of Laparoscopic Splenectomy on the Immune Function for Cirrhosis Patients

ELSI
Start date: March 1, 2022
Phase: N/A
Study type: Interventional

In this study, the investigators compared the improvement of and azygoportal disconnection related indicators in patients with liver cirrhosis after laparoscopic splenectomy. To determine whether surgical treatment can help enhance postoperative immune function and improve patient prognosis.

NCT ID: NCT05338294 Recruiting - Cirrhosis, Liver Clinical Trials

The Effect of Laparoscopic Splenectomy and Azygoportal Disconnection on the Immune Function for Cirrhosis Patients

ELSDI
Start date: March 1, 2022
Phase: N/A
Study type: Interventional

In this study, the investigators compared the improvement of immune function related indicators in patients with liver cirrhosis after laparoscopic splenectomy and azygoportal disconnection. To determine whether surgical treatment can help enhance postoperative immune function and improve patient prognosis.

NCT ID: NCT05325437 Recruiting - Portal Hypertension Clinical Trials

The Effect of Laparoscopic Splenectomy and Azygoportal Disconnection on Liver Reserve Function for Cirrhosis Patients

ELSDL
Start date: March 1, 2022
Phase: N/A
Study type: Interventional

In this study, the investigators compared the improvement of liver reserve function related indicators in patients with liver cirrhosis after laparoscopic splenectomy and azygoportal disconnection. To determine whether surgical treatment can help enhance postoperative liver reserve function and improve patient prognosis.

NCT ID: NCT05325424 Recruiting - Cirrhosis, Liver Clinical Trials

The Effect of Laparoscopic Splenectomy on Liver Reserve Function for Cirrhosis Patients

ELSL
Start date: March 1, 2022
Phase: N/A
Study type: Interventional

In this study, the investigators compared the improvement of liver reserve function related indicators in patients with liver cirrhosis after laparoscopic splenectomy. To determine whether surgical treatment can help enhance postoperative liver reserve function and improve patient prognosis.

NCT ID: NCT05184647 Not yet recruiting - Splenectomy; Status Clinical Trials

Total Splenectomy vs Partial Splenectomy in Non-malignant Hemoglobinopathies : Study Comparing the Effectiveness

Start date: January 16, 2022
Phase:
Study type: Observational

Partial splenectomy or total splenectomy are the two surgical treatment of non-malignant hemoglobinoptahie. The aim of this treatment is to decrease transfusion. The main risk is infectious in total splenectomy, that's why partial splenectomy was suggest. But the efficiency of partial splenectomy decrease over time and a totalisation could be mandatory.

NCT ID: NCT04645550 Completed - Cirrhosis Clinical Trials

Apixaban, Warfarin and Aspirin Prevents Portal Vein Thrombosis in Patients After Laparoscopic Splenectomy(ESAWAAPT)

Start date: November 22, 2020
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether Apixaban, Warfarin and Aspirin Anticoagulation are effective and safe in Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients after Laparoscopic Splenectomy

NCT ID: NCT04056507 Completed - Clinical trials for Immune Thrombocytopenic Purpura

Immunological Markers in Adult Patients With Immune Thrombocytopenic Purpura

SPLENOTIR
Start date: April 12, 2012
Phase:
Study type: Observational

The aim of this study is to determine histological immunological parameters, sought on splenectomy pieces that may explain the failure or success of splenectomy in patients with ITP who had a splenectomy to treat their ITP(Immune thrombocytopenic purpura).

NCT ID: NCT03571399 Completed - Splenectomy; Status Clinical Trials

A Nationwide Italian Survey on Asplenia

Start date: March 1, 2016
Phase:
Study type: Observational

Spleen is involved in several functions, such as the production of protective antibodies, the removal of unwanted particulate matter from the blood (eg bacteria) and also the storing of blood cells, especially white cells and platelets. Asplenia is a status due to spleen absence or dysfunction, which results from several rare diseases. Congenital Asplenia is a condition with absent or dysfunctional spleen, associated with other congenital abnormalities; functional asplenia is a status with present but dysfunctional spleen, related to many rare diseases, such as sickle cell disease, thalassemia, essential thrombocythaemia, lymphoproliferative diseases and splenectomy is the surgical removal of the spleen in order to treat a huge number of rare hematological and oncological diseases. So, asplenia is the final result of a numerous variety of rare disorders, and it leads to a high risk of infections and thrombotic events with significant mortality and morbidity. Antibiotic prophylaxis and specific vaccinations are recommended in this high risk population but adherence was shown to be very poor. A national register was demonstrated to improve population outcomes and reduce health care costs and facilitate research and public health purposes in this target population. In Europe very little experience exists in comprehensive national program for management of asplenia, and only in a restricted part of England and in Ireland surveys of post-splenectomized patients have been performed. In Italy no common policy of patient care has yet been developed, and management of asplenia is mainly case or locally directed.

NCT ID: NCT03117192 Completed - Immunosuppression Clinical Trials

Zinc Supplementation on Cellular Immunity in Thalassemia Major

Start date: September 1, 2013
Phase: Phase 4
Study type: Interventional

Randomized controlled trial was conducted in post-splenectomy patients aged >12 years. Subjects are randomly assigned to two groups (zinc and placebo). 1.5 mg/kg/day (max 50 mg/day) of Zinc is administered.