Performance Evaluation of the ex Utero Cord Blood Collection Technique: Procedure, Quality and Results
NCT ID: NCT05836974
Last Updated: 2024-10-02
Study Results
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Basic Information
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COMPLETED
NA
133 participants
INTERVENTIONAL
2023-09-01
2024-09-25
Brief Summary
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The priority is to increase the quality of cord blood by collecting units that have more stem cells with less contamination so that more patients can benefit, that is, improving the efficiency of the process.
The conventional in utero technique allowed for a more rapid diffusion of cord blood donation programs as it does not require accessories or additional personnel to carry it out. The UCB donation program was initiated in Catalonia in 1995, and since then, this has been the technique used (www.bancsang.net/info-corporativa/qui-som). Some comparisons have been made in the scientific literature with the results found . Currently, there are some new applications of UCB that require its use in fresh form, and it would be beneficial to minimize the risk of bacterial contamination that seems to be reduced with ex utero collection. Therefore, the proposition for this study is to confirm equivalence in quality characteristics and create opportunities for its extensive application.
Currently, cord blood donation is offered to all expectant mothers, provided that the donor does not have any medical exclusion. A very small number of the collected units are suitable for clinical use once processed, making donation programs truly inefficient. This inefficiency generates a workload and waste of public resources that are limited and can also cause ethical dilemmas. Therefore, new strategies are needed to increase the efficiency of donation programs. The Blood and Tissue Bank (BST) has an efficiency improvement study underway using the ex-utero collection technique. The development of this methodology will allow later to propose expanded collection methods, such as the simultaneous collection of cord blood and placenta.
The update of new protocols in childbirth care encourages to explore new systematic umbilical cord blood collection methods with the following objectives: to intervene less in the delivery room obtaining products of equal quality and less contamination and to facilitate the simultaneous donation of UCB and placenta in the future. To ensure that the units have maximum quality, both cellular and free of bacteriology, and can be used safely, the investigators propose the implementation of ex utero cord blood collection. The ex-utero UCB collection involves minimal manipulation, allowing for better cord asepsis. After the birth of the baby and cord clamping at one minute, the investigators wait for the delivery of the placenta and proceed to obtain the ex-utero UCB sample. Thanks to this technique, residual cord blood can be obtained, and the placenta can be collected simultaneously, maintaining the same volume as in in utero collection and reducing contamination and hemolysis of the samples.
This technique poses no risk to either the mother or the baby. The ex-utero cord blood collection technique is a validated technique used in different studies.
To verify these data in our environment and propose a change in the cord blood collection strategy in public banks, this study has been designed.
If the investigators demonstrate that this methodology meets quality objectives, similar to the in-utero technique but significantly reducing associated contamination from the delivery field and the presence of hemolysis, the cord blood bank can implement this new systematic method in centers with highly trained collection personnel, releasing obstetric professionals from their intervention in the delivery room and favoring better quality of the products obtained.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Ex-utero cord blood collection
Ex-utero cord blood collection
Ex-utero cord blood collection
SCU units are collected after placental delivery (ex-utero) by trained obstetric personnel. The cord is clamped at one minute postpartum. Once the placenta is expelled, it is rapidly transported to the collection area, which contains supplies and a surgical table designed for ex-utero SCU collection. This table has a top tray supported by an armrest. The placenta is placed on this specially designed tray with a central hole that allows the umbilical cord to hang. Proper asepsis of the cord is first performed with povidone-iodine and then with 70% alcohol. Subsequently, the umbilical vein is cannulated at the most distal point of the placenta, and placental blood is collected by gravity into a sterile bag. Gentle massage can be applied to the placenta to continue draining blood by gravity. If visible blood remains, a second puncture can be made by bringing the needle insertion point closer to the placenta.
In-utero cord blood collection
In-utero cord blood collection
In-utero cord blood collection
The cord blood is clamped in a delayed modality, defined as after at least 1 minute after delivery. The cord is sterilized, and cord blood is collected using aseptic technique (proper asepsis of the cord is first performed with povidone-iodine and then with 70% alcohol). Blood is allowed to flow by gravity and the needle is removed when blood flow ceases.
Interventions
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Ex-utero cord blood collection
SCU units are collected after placental delivery (ex-utero) by trained obstetric personnel. The cord is clamped at one minute postpartum. Once the placenta is expelled, it is rapidly transported to the collection area, which contains supplies and a surgical table designed for ex-utero SCU collection. This table has a top tray supported by an armrest. The placenta is placed on this specially designed tray with a central hole that allows the umbilical cord to hang. Proper asepsis of the cord is first performed with povidone-iodine and then with 70% alcohol. Subsequently, the umbilical vein is cannulated at the most distal point of the placenta, and placental blood is collected by gravity into a sterile bag. Gentle massage can be applied to the placenta to continue draining blood by gravity. If visible blood remains, a second puncture can be made by bringing the needle insertion point closer to the placenta.
In-utero cord blood collection
The cord blood is clamped in a delayed modality, defined as after at least 1 minute after delivery. The cord is sterilized, and cord blood is collected using aseptic technique (proper asepsis of the cord is first performed with povidone-iodine and then with 70% alcohol). Blood is allowed to flow by gravity and the needle is removed when blood flow ceases.
Eligibility Criteria
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Inclusion Criteria
* Geographical origin and history of known travels
* Absence of potentially transmissible diseases (infectious, hematological, and autoimmune)
* Absence of diseases that can alter prenatal obstetric variables: multiple pregnancy, pregestational diabetes mellitus, intrauterine growth restriction, hypertensive states of pregnancy or chronic arterial hypertension, and fetal pathology.
* Any type of delivery: vaginal delivery and cesarean section.
* Deliveries from week 37 or higher.
* Standardization of the timing of clamping in all cases to one minute.
18 Years
50 Years
FEMALE
Yes
Sponsors
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Fundacion Dexeus
OTHER
Responsible Party
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Nimet Caner
Principal Investigator
Locations
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Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus
Barcelona, , Spain
Countries
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References
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Querol S, Gomez SG, Pagliuca A, Torrabadella M, Madrigal JA. Quality rather than quantity: the cord blood bank dilemma. Bone Marrow Transplant. 2010 Jun;45(6):970-8. doi: 10.1038/bmt.2010.7. Epub 2010 Mar 1.
Rocha V, Gluckman E; Eurocord and European Blood and Marrow Transplant Group. Clinical use of umbilical cord blood hematopoietic stem cells. Biol Blood Marrow Transplant. 2006 Jan;12(1 Suppl 1):34-41. doi: 10.1016/j.bbmt.2005.09.006.
Gluckman E. Milestones in umbilical cord blood transplantation. Blood Rev. 2011 Nov;25(6):255-9. doi: 10.1016/j.blre.2011.06.003. Epub 2011 Jul 20.
Solves Alcaina P, Perales Marin A, Mirabet Lis V, Brik Spinelli M, Soler Garcia MA, Roig Oltra R. [Donors selection and retrieval of units in an umbilical cord blood bank]. Med Clin (Barc). 2007 Oct 27;129(15):561-5. doi: 10.1157/13111706. Spanish.
Magalon J, Maiers M, Kurtzberg J, Navarrete C, Rubinstein P, Brown C, Schramm C, Larghero J, Katsahian S, Chabannon C, Picard C, Platz A, Schmidt A, Katz G. Banking or Bankrupting: Strategies for Sustaining the Economic Future of Public Cord Blood Banks. PLoS One. 2015 Dec 1;10(12):e0143440. doi: 10.1371/journal.pone.0143440. eCollection 2015.
Kurtzberg J, Cairo MS, Fraser JK, Baxter-Lowe L, Cohen G, Carter SL, Kernan NA. Results of the cord blood transplantation (COBLT) study unrelated donor banking program. Transfusion. 2005 Jun;45(6):842-55. doi: 10.1111/j.1537-2995.2005.04428.x.
Bart T, Boo M, Balabanova S, Fischer Y, Nicoloso G, Foeken L, Oudshoorn M, Passweg J, Tichelli A, Kindler V, Kurtzberg J, Price T, Regan D, Shpall EJ, Schwabe R. Impact of selection of cord blood units from the United States and swiss registries on the cost of banking operations. Transfus Med Hemother. 2013 Feb;40(1):14-20. doi: 10.1159/000345690. Epub 2013 Jan 7.
Committee Opinion No. 684: Delayed Umbilical Cord Clamping After Birth. Obstet Gynecol. 2017 Jan;129(1):1. doi: 10.1097/AOG.0000000000001860.
Lin X, Torrabadella M, Amat L, Gomez S, Azqueta C, Sanchez M, Cuadras D, Martinez Lorenzo MJ, Brull JM, Gaya A, Cemborain A, Perez Garcia C, Arroyo J, Querol S, Gomez Roig MD. Estimated fetal weight percentile as a tool to predict collection of cord blood units with higher cellular content: implications for prenatal selection of cord blood donors. Transfusion. 2018 Jul;58(7):1732-1738. doi: 10.1111/trf.14651. Epub 2018 May 6.
Vanegas D, Trivino L, Galindo C, Franco L, Salguero G, Camacho B, Perdomo-Arciniegas AM. A new strategy for umbilical cord blood collection developed at the first Colombian public cord blood bank increases total nucleated cell content. Transfusion. 2017 Sep;57(9):2225-2233. doi: 10.1111/trf.14190. Epub 2017 Jun 26.
Solves P, Moraga R, Saucedo E, Perales A, Soler MA, Larrea L, Mirabet V, Planelles D, Carbonell-Uberos F, Monleon J, Planells T, Guillen M, Andres A, Franco E. Comparison between two strategies for umbilical cord blood collection. Bone Marrow Transplant. 2003 Feb;31(4):269-73. doi: 10.1038/sj.bmt.1703809.
Solves P, Moraga R, Mirabet V, Larrea L, Soler MA. In utero or ex utero cord blood collection: an unresolved question. Transfusion. 2003 Aug;43(8):1174-6; author reply 1176. doi: 10.1046/j.1537-2995.2003.00459.x. No abstract available.
Related Links
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Related Info
Other Identifiers
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FSD-BST-2022-08
Identifier Type: -
Identifier Source: org_study_id
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