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Anemia, Sickle Cell clinical trials

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NCT ID: NCT02766465 Completed - Sickle Cell Disease Clinical Trials

Bone Marrow Transplantation vs Standard of Care in Patients With Severe Sickle Cell Disease (BMT CTN 1503)

STRIDE2
Start date: November 2016
Phase: Phase 2
Study type: Interventional

This is a clinical trial that will compare survival and sickle related outcomes in adolescents and young adults with severe sickle cell disease after bone marrow transplantation and standard of care. The primary outcome is 2-year overall survival.

NCT ID: NCT02757885 Completed - Sickle Cell Disease Clinical Trials

Transplantation for Patients With Sickle Cell Disease From Mismatched Family Donors of Bone Marrow

TRANSFORM
Start date: July 10, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to learn if it is possible and safe to treat persons with severe sickle cell disease (SCD) by bone marrow transplant (BMT) from human leukocyte antigen (HLA) half-matched related donors. Preparation before transplant includes the chemotherapy drugs hydroxyurea, fludarabine, thiotepa, anti-thymocyte globulin, and cyclophosphamide. It also includes radiation.

NCT ID: NCT02731157 Completed - Sickle Cell Disease Clinical Trials

Rejuvesol® Washed RBC in Sickle Cell Patients Requiring Frequent Transfusions

Start date: December 2016
Phase: Phase 4
Study type: Interventional

The objective of this proposal is to test the feasibility of red blood cell (RBC) rejuvenation to chronic transfusion in sickle cell disease (SCD) and the potential benefit of RBC rejuvenation in this population to determine if a larger clinical trial powered to definitively characterize the benefits of rejuvenation is warranted. This is a small pilot study is to see if restoring important energy molecules (ATP and 2,3,DPG) in stored red blood cells before they are transfused, with a rejuvenating solution (Rejuvesol), offers any advantages to individuals over standard blood transfusion. Subjects will receive either rejuvenated (R) or standard (S) RBCs with each transfusion for 6 transfusions (over approximately a 6-month period) in a pre-defined order to maximize detection of any signal.

NCT ID: NCT02729363 Completed - Pain Clinical Trials

The Feasibility of the PAINReportIt Guided Relaxation Intervention-Outpatient

Start date: April 2016
Phase: N/A
Study type: Interventional

Our goal is to improve the self-management of pain and stress in adult outpatients with sickle cell disease (SCD) by determining the feasibility of a self-managed guided relaxation (GR) stress reduction intervention using a tablet-based mobile device. Currently, opioid analgesics are primarily used to treat SCD pain while self-managed behavioral modalities such as GR, are rarely used. Little is known about the effects or mechanisms of GR on pain and stress, in adults with SCD. Emerging evidence from the hypothalamic pituitary adrenal (HPA) axis theory offer insights for understanding the mechanisms. Adding GR as a supplement to analgesic therapies will address the paucity of self-management strategies for controlling pain in SCD. GR is a simple and cost-effective non-drug intervention that could reduce pain and stress in outpatients with SCD. GR is an intervention where outpatients with SCD are directed to listen to and view audio-visual recordings while they visualize themselves being immersed in that scene.

NCT ID: NCT02721472 Completed - Sickle Cell Disease Clinical Trials

Plasma DNA and Vascular Remodelling in Patients With Sickle Cell Disease

PADRE
Start date: May 17, 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the relationship between plasma DNA levels and micro- and macro-circulatory vascular remodelling in patients with sickle cell disease

NCT ID: NCT02712346 Completed - Sickle Cell Anemia Clinical Trials

The Role of Endothelin-1 in Sickle Cell Disease

Start date: September 2015
Phase: Phase 1
Study type: Interventional

The primary goal of the study is to determine the safety and tolerability of ambrisentan. It is also expected that ambrisentan will improve blood flow in the lungs, decrease inflammation, and reduce pain in sickle cell patients. An additional goal is to evaluate the use of select biomarkers in evaluating sickle nephropathy.

NCT ID: NCT02709681 Completed - Sickle Cell Disease Clinical Trials

Hydroxyurea in the Treatment of Sickle Cell Disease

Start date: November 2015
Phase: N/A
Study type: Observational

This is a retrospective cohort study of Sickle Cell Disease (SCD) patients attending 32 treatment centers across Italy. The aim of this study will be to report the Italian experience with the use of hydroxyurea in a large cohort of SCD patients and to evaluate the benefits and safety of this intervention for the prevention and management of a wide range of clinical morbidities

NCT ID: NCT02697240 Completed - Sickle Cell Disease Clinical Trials

A Phase 1 Study of Continuous Intravenous L-citrulline During Sickle Cell Pain Crisis or Acute Chest Syndrome

Start date: February 2016
Phase: Phase 1
Study type: Interventional

Sickle cell disease is a genetic red blood cell disorder characterized by vaso-occlusion from sickling of red blood cells, that can lead to pain or organ complications such as acute chest syndrome. Sickle cell disease is associated with low amounts of nitric oxide, a compound important for dilating the blood vessel wall. Citrulline is a substance that is known to increase nitric oxide. The goal of this Phase I study are to find the highest safe dose of continuous IV citrulline that can be given to individuals with sickle cell disease experiencing a sickle cell pain crisis or acute chest syndrome without causing severe side effects.

NCT ID: NCT02675790 Completed - Stroke Clinical Trials

Moderate Dose Hydroxyurea for Secondary Stroke Prevention in Children With Sickle Cell Disease in Sub-Saharan Africa

SPRINT
Start date: January 2017
Phase: Phase 3
Study type: Interventional

The overall goal of the proposed study is to determine the effectiveness of hydroxyurea therapy for secondary stroke prevention and prevention of other neurological events in children with SCA with an acute overt stroke.

NCT ID: NCT02672540 Completed - Anemia, Sickle Cell Clinical Trials

A Study of SANGUINATE for the Treatment of Vaso-occlusive Crisis (VOC) in Adult Sickle Cell Disease Patients

Start date: July 2016
Phase: Phase 2
Study type: Interventional

Safety and effect of SANGUINATE on Sickle Cell Disease patients experiencing a vaso-occlusive crisis who are admitted to the hospital for treatment.