Ready to upload
Adverse Occurrence type:
In Europe, between 2005-2009 a total of 600-700 minor donors donated annually; this number increased to over 1300/yr in recent years (1/3 of all allogeneic pediatric transplantations (n=4075) in Europe). Donation is only allowed to siblings; however, some countries allow stem cell collection to other close relatives (parent, grandparent, cousin). Majority (69%) donate bone marrow. Reporting of serious adverse events is not regulated, and probably underreported.
Time to detection:
The study investigated risks and complications during donation/collection of stem cells only. The only serious adverse occurrence reported in this study was a pneumothorax/hydrothorax after PBSC collection (CVC related) in a 5 year old child (1 of 140 PBSC donors = 0,7%; 1 of 81 CVC placements = 1,2%).
Alerting signals, symptoms, evidence of occurrence:
Median BM volume of 18,5 mL/kg of donor weight was collected (range 2-66ml). Upper respiratory tract infections observed after collection in 3 BM donors. Over 25% of BM donors and 6% of PBSC donors were exposed to allo red blood cell transfusion. Thrombocytopenia (<70g/L) was seen in 4% of PBSC donors, one donor received a platelet transfusion (thrombo 51g/L), prior to a third collection procedure. Two centers routinely administered erythropoietin (31 donors, 10%) A central venous catheter for PBSC collection was necessary in 81/140 donors, (6 were younger than 4yr), 46% (n=37) were placed under general anaesthesia, the remainder of these donors received conscious sedation. Age is only significant factor associated with risk of complications of anaesthesia after CVC placement. Side effects of G-CSF administration were comparable with known complaints in adults (headache, bone pain etc). One collection procedure was sufficient in 32%, 57% underwent 2 procedures, 11% underwent 3 procedures.
Demonstration of imputability or root cause:
Hemodynamic instability (decreased blood pressure, tachycardia, bradycardia) as a complication of anaesthesia was seen in 10% of BM donors and 4 PBSC donors. D/R weight ratio was significantly associated with the risk of cardiac complications after BM harvest under anaesthesia. D/R weight ratio and WBC <50g/L were idependent risk factors for additional aphaeresis requirement. Symptomatic hypocalcemia (as a result of exposure to anticoagulans during the procedure) was seen in 21% (n=30)
Suggest new keywords:
allo blood transfusion
Risk of complications during hematopoietic stem cell collection in pediatric sibling donors: a prospective European Group for Blood and Marrow Transplantation Pediatric DiseasesWorking Party study. Styczynski et al, BLOOD, 22 MARCH 2012 VOLUME 119, NUMBER 12
Expert comments for publication:
This study focused on collection of stem cells in minors, and reported only one serious adverse occurrence (pneumothorax after CVC placement). Risks of harm for the donor include transfusion of allogeneic blood products, (complications of) general anesthesia, excessive harvesting of bone marrow (>15 ml BM/kg donor body weight), need for CVC placement, (long term) effects of G-CSF administration (not investigated in minor donors). The authors mention that 'modifications in cilnical practice could potentially diminish the risk of HSC collection in very small children'.