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Thrombocytopenia clinical trials

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NCT ID: NCT06099925 Not yet recruiting - Clinical trials for Chemotherapy-induced Thrombocytopenia

The Efficacy and Safety of Hetrombopag as Secondary Prevention to Chemotherapy-induced Thrombocytopenia in Patients With Gynecologic Malignancies

Start date: October 16, 2023
Phase: Phase 2
Study type: Interventional

Chemotherapy is an important treatment strategy for gynecological malignancies, such as ovarian cancer, advanced endometrial cancer, cervical cancer. Chemotherapy-induced thrombocytopenia (CIT) is one of the most common chemotherapy-related hematologic toxicities and can increase the risk of bleeding, prolong hospital stays, increase healthcare costs, and, in severe cases, death. It can lead to a reduction in the intensity of chemotherapy doses, delay the next cycle of chemotherapy, or even termination of treatment, thereby affecting the antitumor effect and adversely affecting the long-term survival of these patients. Literature and our data show that when patients develop grade II or worse CIT, the incidence of grade II and above CIT after the next cycle of chemotherapy is 85-92%. Hetrombopag is one of the thrombopoietin receptor agonist (TPO-RA) that has been studied to explore its role in the treatment and prevention of CIT in multiple solid tumors. In order to find out the secondary prevention efficacy of CIT, it is planned to carry out this single-arm prospective study by recruiting 48 patients with gynecological malignancies with grade II CIT or above after chemotherapy, whose platelets has returned to normal after the routine clinical intervention, and then plan to have the next cycle of chemotherapy. The intervention strategy is taking hetrombopag 5mg/day within 24 hours after chemotherapy, then observe the incidence rate of grade II CIT. The endpoint of this study is to assess the effectiveness and safety of hetrombopag for preventing CIT in patients with gynaecological malignancies.

NCT ID: NCT06095648 Not yet recruiting - Thrombocytopenia Clinical Trials

Study Comparing Platelet Transfusion Volumes in Premature Babies

PlaNeT-3
Start date: October 28, 2023
Phase: N/A
Study type: Interventional

Platelet transfusions can help clotting but may also have risks. Currently when babies get platelet transfusions they get as much as three times (per kilogram of body weight) as much as adults do. The goal of this clinical trial is to to find out which volume of platelets should be transfused to premature babies with low platelets and no bleeding. The main question it aims to answer is if a smaller volume for platelet transfusion can help prevent death and severe bleeding and also have fewer side effects for the baby. Participants will be placed at random into one of two groups: In Group 1, babies will get a platelet transfusion based on the volume of 5mls/kg weight, in Group 2, babies will get a platelet transfusion based on the volume of 15mls/kg weight. Babies will remain in their allocated group during their stay on the neonatal unit so that they always receive the allocated volume unless a clinician decides otherwise.

NCT ID: NCT06093529 Not yet recruiting - Clinical trials for ITP - Immune Thrombocytopenia

Immune Markers in Pediatric ITP on Second Line Therapy

Start date: January 1, 2024
Phase:
Study type: Observational

Immune thrombocytopenia (ITP) is a common autoimmune disease characterized by low platelet count and increased risk of bleeding. It affects approximately 50 to 100 cases per million people per year, with children accounting for half of the cases.

NCT ID: NCT06073925 Not yet recruiting - Clinical trials for Immune Thrombocytopenia

Use of Vitamin D as An Adjuvant Treatment in Children With Chronic Idiopathic Thrombocytopenic Purpura

MansouraU
Start date: December 2023
Phase: Early Phase 1
Study type: Interventional

Immune thrombocytopenia is an autoimmune disease in which platelets are targeted by the host immune system. Platelet depletion occurs when autoantibodies targeting glycoproteins (αIIb-β3 and GPIb) found on the surface of platelets opsonize the cells, resulting in destruction by macrophages. These antibodies can also bind to megakaryocytes and prevent complete maturation, which results in lowered levels of platelet production Vitamin D (VD) or 1,25-dihydroxyvitamin D, may be a potent immunomodulator, and it may have potential therapeutic use in many autoimmune diseases In 1991, researchers found that the production of interleukin (IL)-6 and IL-2 in cell cultures were reduced by 1,25(OH)2D3 VD deficiency is very common in children with either newly diagnosed or chronic ITP form.Correlation between hypovitaminosis D and a higher incidence of infections and autoimmune diseases was reported as well Case-Control interventional study (over time each participant will be randomized to be enrolled in one of either study arms in a random sequence). To evaluate the efficacy of VD supplementation as an adjuvant therapy in chronic ITP children and its effect on platelet count and bleeding score. The participants will be - Children from 1 year to 18 years diagnosed with Chronic ITP with platelet count <100,000/microL. Patients groups will be: Patients of Chronic ITP aged from 1year till 18 years old . in this study will be divided into 2 groups ● Group A : All patients with VIT D insufficiency(The preferred level for 25(OH)D is now recommended by many experts to be >30 ng/ml) will receive supplementary Vitamin D3(NIVAGEN Vitamin D3 Cholecalciferol 50000 IU) oral once weekly for 3 months as adjuvant therapy in combination with their treatment for ITP. ● Group B : patients in this group have sufficient VIT D level and will be divided into 2 groups : - Group 1 B :will receive their standard treatment for ITP with VIT D. - Group 2 B :will receive their standard treatment for ITP without VIT D. Complete blood picture will be made at the beginning of study then monthly to evaluate the number of platelets that expected to increase after VD supplementation

NCT ID: NCT06066762 Not yet recruiting - Clinical trials for Heparin-induced Thrombocytopenia

Argatroban Monitoring in Acute Suspected Heparin-induced Thrombocytopenia.

TIH-FM
Start date: November 1, 2023
Phase:
Study type: Observational

Heparin-induced thrombocytopenia (HIT) is a rare but potentially serious complication of heparin therapy. , argatroban is the alternative anticoagulant of choice in patients with suspected HIT and renal impairment, high bleeding risk or risk of invasive surgery/gesture. Despite its increasing use in these fragile patients, methods for biological monitoring of argatroban's anticoagulant activity are heterogeneous, and neither the therapeutic zone nor the modalities for argatroban dosage adjustment are clearly defined, particularly in patients in the acute phase of thrombosis. Soluble fibrin monomers (FM) indirectly reflect thrombin generation in vivo. This marker could thus represent a new strategy for monitoring the anticoagulant activity of argatroban. However, the effect of argatroban anticoagulation on FM levels remains unknown. In a preliminary retrospective study carried out at Bichat hospital, we showed that FM levels could therefore be an early marker of the efficacy of argatroban treatment in patients with suspected HIT.In order to confirm these results, we will include patients with clinico-biological suspicion of HIT and receiving argatroban treatment. Ten French laboratories will participate in this study. All plasmas collected will be from samples taken only in the context of care. This prospective study will determine whether the daily monitoring of FM is beneficial for the management of patients treated with argatroban.

NCT ID: NCT06036966 Not yet recruiting - Thrombocytopenia Clinical Trials

The Efficacy and Safety of Hetrombopag in Primary Prevention of Thrombocytopenia Induced by the Niraparib Maintenance in Advanced Ovarian Cancer Patients

Start date: September 16, 2023
Phase: Phase 2
Study type: Interventional

Niraparib brings a better prognosis to those with advanced ovarian cancer and has been approved by the Food and Drug Administration(FDA )and National Medical Products Administration(NMPA)as one of the maintenance therapies for the advanced ovarian cancer patients. Thrombocytopenia is one of the adverse effects of Niraparib, with a 61% overall incidence and 34% of the grade 3~4 incidence. Thrombocytopenia may cause suspension or dose reduction of Niraparib which will affect the therapeutic effect of the drug. At present, the drugs recommended by the guidelines for the treatment of thrombocytopenia are recombinant thrombopoietin (rhTPO), recombinant interleukin 11 (rhIL-11), TPO receptor agonist (TPO-RA). Hetrombopag is one of the TPO-RA, which is recommended by the Chinese expert consensus to cure the thrombocytopenia caused by poly adenosinediphosphate ribose polymerase(PARP) inhibitors, including Niraparib. However, is it effective when it is used as the primary prevention during the maintenance therapy of Niraparib? This single-arm study aims to explore the efficacy and safety of hetrombopag for the prevention of thrombocytopenia caused by Niraparib maintenance therapy in advanced ovarian cancer patients. 34 patients will be recruited and they will take hetrombopag 5mg per day for 8 weeks when they initiate the maintenance therapy with Niraparib. The primary endpoint of this study is the rate of thrombocytopenia according to Common Terminology Criteria for Adverse Events 5.0(CTCAE5.0).

NCT ID: NCT05998759 Not yet recruiting - Thrombocytopenia Clinical Trials

Telitacicept for the Treatment of Connective Tissue Disease-associated Thrombocytopenia

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

The goal of this clinical trial is to evaluate the efficacy and safety of Telitacicept for the treatment of connective tissue disease-associated thrombocytopenia.

NCT ID: NCT05969158 Not yet recruiting - Clinical trials for Chemotherapy-Induced Thrombocytopenia

Hetrombopag in Secondary Prevention of XPO-1 Inhibitor-induced Thrombocytopenia in Lymphoma

Start date: September 4, 2023
Phase: Phase 2
Study type: Interventional

To explore the efficacy and safety of hetrombopag for secondary prevention of thrombocytopenia caused by XPO-1 inhibitor Selinexor combined with chemotherapy in patients with lymphoma.

NCT ID: NCT05958511 Not yet recruiting - Thrombocytopenia Clinical Trials

Assessment of Risk Factors and Outcome of Thrombocytopenia in ICU Patients

Start date: September 1, 2023
Phase:
Study type: Observational

The many comorbidities in the severely ill patient also make thrombocytopenia very common (∼ 40%) in intensive care unit patients. The risk of bleeding is high with severe thrombocytopenia and is enhanced in intensive care patients with mild or moderately low platelet counts when additional factors are present that interfere with normal hemostatic mechanisms (eg, platelet function defects, hyperfibrinolysis, invasive procedures, or catheters).

NCT ID: NCT05944211 Not yet recruiting - Clinical trials for Chemotherapy-Induced Thrombocytopenia

Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia(CIT) in Patients With Acute Myeloid Leukemia

H-CIT-AML
Start date: July 2023
Phase: Phase 2
Study type: Interventional

Randomized, controlled, open study to evaluate the efficacy and safety of Hetrombopag in the treatment of chemotherapy-induced thrombocytopenia(CIT) in patients with acute myeloid leukemia