Suspendido

Randomized Crossover Study Comparing Fresh Random Platelets and Autologous Cryopreserved Thrombosol Treated Autologous Platelets

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

Platelet Transfusion

Biológico
Quiénes están siendo reclutados

Enfermedades Hematológicas+1

+ Leucemia

+ Neoplasias

Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Tratamiento

Fase 3
Intervencional
Inicio del estudio: julio de 2003
Ver detalles del protocolo

Resumen

Patrocinador PrincipalM.D. Anderson Cancer Center
Última actualización: 14 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 1 de julio de 2003

Fecha en la que se inscribió al primer participante.

Platelets are an important component of blood. Transfusions with platelets help to control bleeding in thrombocytopenic patients. Using the standard blood banking procedures, platelets can only be stored for up to 5 days. This is to help decrease the risk of contamination with bacteria. Currently, it is not possible to use cryopreserved (frozen) platelets because the platelets are damaged during the freezing process. Therefore, long-term banking of platelets or autologous donation (storing your own platelets to be given back to you at a later time) has not been possible. ThromboSol is a new solution that was designed to allow platelets to be frozen without damaging them. The use of ThromboSol may allow for long-term banking of platelets and/or autologous donations. During a period of cancer remission and when you have enough platelets in your blood, you will undergo an apheresis procedure to collect platelets. This procedure is similar to donating plasma to a blood bank. You will have up to 6 apheresis procedures (on different days) to collect up to 6 units of autologous platelets that can be transfused back to you. The platelets that are collected will be frozen with ThromboSol and stored so that they may be given back to you if your platelet count drops below a certain level. The frozen platelets can be stored for up to 18 months. When your platelet count drops below a certain level, you will be scheduled to have a platelet transfusion as part of your standard care. Before the transfusion you will have blood drawn (around 1-2 teaspoons) to check on the number of platelets in your blood. You will then be randomly assigned (as in the toss of a coin) to either receive the standard platelet transfusion or a ThromboSol-preserved autologous platelet transfusion. After the transfusion, you will have additional blood drawn (around 1-2 teaspoons) to check on the number of platelets in your blood. These procedures will be repeated each time you require a platelet transfusion. However, you will not be randomly assigned again. Each time you receive an additional platelet transfusion, you will be assigned the group different from the one before. The type of transfusions will be alternated. For instance, if you were randomly assigned to receive the frozen platelets for your first transfusion, you will receive the standard transfusion next, then back to the frozen for the third transfusion. If you develop side effects to the ThromboSol-preserved autologous platelet transfusion or the number of platelets in your blood does not increase after an infusion with the preserved platelets, you will be taken off the study and given a standard platelet transfusion. This is an investigational study. Up to 54 participants will take part in this study. All will be enrolled at UTMDACC.

Título OficialRandomized Crossover Study Comparing Fresh Random Platelets and Autologous Cryopreserved Thrombosol Treated Autologous Platelets 
NCT00074763
Patrocinador PrincipalM.D. Anderson Cancer Center
Última actualización: 14 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 4 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Tratamiento

Estos estudios prueban nuevas formas de tratar una enfermedad, condición o problema de salud. El objetivo es determinar si un nuevo medicamento, terapia o enfoque funciona mejor o tiene menos efectos secundarios que las opciones existentes.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

Voluntarios sanos permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

Enfermedades HematológicasLeucemiaNeoplasiasNeoplasias por tipo histológico

Criterios

Inclusion Criteria: 1) 1.- Patients in remission with ALL, CLL, AML, CML, MDS will be allowed to participate in this program if their platelet count is \>150K, and the hemoglobin level is at least 8.0g/dl. The patient will receive their autologous platelets cryopreserved in ThromboSol or the fresh random platelets (FRP) whenever the need for such transfusions is determined to be clinically indicated by their physician(s). Exclusion Criteria: 1) Patients with detectable circulating malignant cells or ongoing marrow involvement by the tumor will not be eligible.

Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

Un solo grupo de intervención está designado en este estudio

0% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Experimental
ThromboSol-preserved autologous platelet transfusion or Standard platelet transfusion. All patients receive both platelets frozen with Thrombosol and fresh random platelets. The order in which patients receive these two types of platelets randomized in a crossover design. Patients randomly assigned to receive either the sequence FRP then Thrombosol or Thrombosol then FRP. The randomization will occur after second cycle of chemotherapy, since all patients will receive FRP with the first cycle.

Objetivos del Estudio

Objetivos Primarios

Objetivos Secundarios

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene una ubicación

Suspendido

UT M.D. Anderson Cancer Center

Houston, United StatesVer ubicación
Suspendido1 Centros de Estudio