Status:
Ready to upload
Record number:
1660
Adverse Occurrence type:
MPHO Type:
Estimated frequency:
Morbidity was great: 21 patients (30%) had major complications resulting in two deaths. Ten episodes of bacteriemia and 2 episodes of fungemia, resulting in one death were documented in 11 patients (from 71 total). The frequency of sepsis was similar with all the catheter types. The rate of sepsis per 1000 patient-catheter days was 7.3. In most patients sepsis occurred soon after catheter insertion.
Alerting signals, symptoms, evidence of occurrence:
Data were prospectively collected on 71 consecutive patients for PE treatment for clinically suspected thrombotic thrombocytopenic purpura–hemolytic-uremic syndrome (TTP-HUS) from mid-1996 to mid-1999. Complications were defined as major or minor,and distinguished between those related to central venous catheter access or to the plasma. Twenty-one patients (30%) had 27 major complications, which caused two deaths. The major complications included 2 episodes of hemorrhage after subclavian line insertion (1 death), 1 pneumothorax requiring a chest tube, 12 systemic infections (1 death), 7 episodes of catheter thrombosis requiring removal of the central venous catheter, 2 episodes of venous thrombosis requiring anticoagulant treatment, 2 episodes of hypoxemia and hypotension, and 1 episode of serum sickness. Minor complications occurred in 22 additional patients (31%). Twenty-eight patients (39%) had no complications.
Demonstration of imputability or root cause:
All 71 patients fulfilled the diagnostic criteria for TTP-HUS (thrombocytopenia and microangiopathic hemolytic anemia); most patients also had neurologic (78%) and renal (92%) abnormalities, and 49 percent of patients had fever. Major catheter-related complications occurred in one patient, a 28-year-old woman who was 5 days postpartum and who died suddenly of hemorrhage after elective insertion of a percutaneous subclavian catheter to replace an initial femoral catheter. Three plasma-related major complications occurred. Two patients developed concurrent hypotension and hypoxemia, presumably caused by an allergic reaction to the plasma: one patient required transfer to an intensive care unit, and the reaction in the other patient prevented the PE procedure from being completed. One patient developed acute polyarthritis, resembling serum sickness, and required treatment with prednisone for 5 weeks. These complications occurred with the use of both FFP and CPP.
Imputability grade:
3 Definite/Certain/Proven
Groups audience:
Keywords:
Reference attachment:
Suggest references:
M.A. Rizvi, S.K. Vesely, J.N. George, L. Chandler, D. Duvall, J.W. Smith, and R.O. Gilcher (2000). Complications of plasma exchange in 71 consecutive patients treated for clinically suspected thrombotic thrombocytopenci purpura-hemolytic-uremic syndrome. Transfusion Volume 40 ; 896-901
Note:
Two different adverse occurrences: catheter related complications (record 1653) and allergic reaction to plasma (record 1660) requiring two different entries - done (Evi, 2015/09/17)
Expert comments for publication:
With the increased frequency of diagnosis and improved survival of thrombotic thrombocytopenic purpura–hemolytic-uremic syndrome (TTP-HUS), the morbidity of plasma exchange (PE) treatment has become more important. The morbidity and mortality of catheter placement and PE are important considerations when PE treatment for clinically suspected TTP-HUS is anticipated.