|- candidate number||1441|
|- NTR Number||NTR256|
|- Date ISRCTN created||20-dec-2006|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||7-sep-2005|
|- Secondary IDs||N/A |
|- Public Title||Premature Umbilical Cord Blood (PUCB).|
|- Scientific Title||The use of autologous cord blood for anemia of prematurity.|
|- hypothesis||Can allogeneic red cell transfusions for preterm/very low birth weight newborns be reduced and is this associated with favourable outcome of usual neonatal complications (infections, cerebral bleeding , duration of assisted ventilation and death) resulting in shortening of the need of vital support necessitating NICU care.|
|- Healt Condition(s) or Problem(s) studied||Brace, Preterm neonates, Premature infants|
|- Inclusion criteria||1. Pregnant women;|
2. Premature (gestational age of < 36 weeks) who require a red blood cell transfusion.
|- Exclusion criteria||1. Hemolytic disease of the newborn; |
2. Maternal infections such as HIV/HCV/HBV/CMV/ Toxoplasma/ Treponema pallidum or maternal septicaemia;
3. Ruptured membranes >24 hr and body temp. >38 gr. C;
4. placenta praevia, version, solutio placentae;
5. antibiotics/fungostatica < 48 hr prior to partus.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-dec-2004|
|- planned closingdate||1-dec-2007|
|- Target number of participants||600|
|- Interventions||Transfusion of autologous red cord blood cell concentrate vs. transfusion of stored allogeneic red blood cell concentrates.|
|- Primary outcome||Proportion of patients who received allogeneic transfusions and the total volume of administered allogeneic red cells.
Days of support of vital functions in the NICU.
|- Secondary outcome||1. Days of assisted ventilation support;|
2. Cumulative complication incidence
(infections, cerebral events);
3. Length of hospital stay;
5. Feasibility of erythrocyte collection from cord blood;
6. Costs of transfusions;
7. Costs of care;
8. 2 year and 5 years neurodevelopmental follow-up.
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. A. Brand|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. A. Brand|
|- Sponsor/Initiator ||ZonMw: The Netherlands Organization for Health Research and Development|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development, Sanquin Bloodbank Amsterdam|
|- Brief summary||Bloodsubstitutes are becoming a pivotal medical aim. Efforts to find blood substitutes instead of donor blood are enforced by the awareness that allogeneic blood transfusions, despite optimal safety precautions, can be associated with worse clinical outcome. In addition there is a realistic expectation of decrease in the numbers of safe blood donors in the near future. |
Preterm newborns with a gestational age less than 32 weeks and/or 32-36 weeks and Apgar score <6 have a high probability to receive blood transfusions. Preterm newborns also have a high risk for respiratory and other organ failure, septicaemia and cerebral bleeding. In adults, blood transfusions are associated with increased morbidity and mortality. It is conceivable that preterm infants are even more susceptible to the adverse effects of allogeneic transfusions. Neonatal diseases may have life-long sequelae such as chronic lung disease, impaired neurodevelopmental outcome and retinipathy.
- Cordblood (CB) is generally discarded, but contains red cells, immature hematopoietic cells and stem cells suitable for autologous and allogeneic usage. CB red cells can be harvested, stored and transfused without side effects.
In the proposed double-blind randomised study we compare the use of autologous CB red cells with allogeneic transfusions.
- Primary outcome measure is a meaningfull (> 50% reduction) in allogeneic red cell transfusions.
- Secondary parameters are
a. postnatal complication rate (infections, duration of respiratory assistance, intracranial bleeding ,length of ICU-stay)
b. feasibility to obtain autologous CB transfusions on a wide scale
c. costs compared to standard treatment.
|- Main changes (audit trail)|
|- RECORD||7-sep-2005 - 18-jan-2010|