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Hematologic Changes clinical trials

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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NCT ID: NCT01958242 Withdrawn - Hematologic Changes Clinical Trials

Effect of Blood Harvesting and Administration at End of CPB on Coagulation Profile

Start date: January 2014
Phase: N/A
Study type: Interventional

Blood transfusions after pediatric heart surgery is a relatively common practice occurring in up to 46% of patients, however its use has been associated with increased morbidity. In the pediatric population undergoing heart surgery transfusion of homologous blood is usually required due to the mismatch between the priming volume of the cardiopulmonary bypass circuit and the patients own blood volume. Several strategies have been proposed in order to minimize the use of blood products. The effect of pre-operative harvest of fresh whole blood in the adult population has shown a beneficial platelet protective effect, however concerns have been risen that the amount of volume needed in order to sequester a significant amount of platelets would be prohibit ally high in a cardiac surgical patient. Fresh blood harvesting has not been evaluated in the pediatric population. The purpose of the present study would be to evaluate the safety and efficacy of pre-operative blood harvesting in the pediatric population undergoing open heart surgery. Fresh whole blood will be harvested from the patient prior to the initiation of cardiopulmonary bypass and will be returned to the patient after the discontinuation of CPB prior to the administration of prominent. Parameters that will be evaluated will include, patient characteristic, operative and post-operative parameters, coagulation profiles and the use of postoperative blood products.