Cohort studyindependent cross-checkabstract checked I-ORG-117 standard review
Blood clots and sepsis after spleen removal in ITP
Splenectomy and the incidence of venous thromboembolism and sepsis in patients with immune thrombocytopenia.
Overview
Boyle S et al.. Blood 2013 · PMID 23637127 · DOI 10.1182/blood-2012-12-467068
Patients whose spleen was removed had more blood clots (4.3% vs 1.7%) and more sepsis than similar patients who kept their spleen.
Does the study support the specific claim? Yes · Methodological quality: moderate
Plain-language summary
Study explained simply
- What did the researchers want to find out?
Measure clot and sepsis risk after splenectomy in ITP
- How was the study done?
Cohort study
- How many people, animals or samples were studied?
9976 ITP patients
- What was actually found?
Higher VTE and sepsis risk, early and late
- How large was the observed effect?
Late VTE HR 2.7
- What do the results mean in everyday life?
Splenectomy has lasting risks to weigh
- What are the study's limitations?
Administrative data
- What does it say about Elawady's specific claim?
Supports the VTE part of the claim
- Do the results apply to Germany and Europe?
Applicable
- What can explicitly not be concluded from this study?
Not more than about a decade of data
Scientific in-depth review
1. Full reference
- Authors
- Boyle S et al.
- Journal
- Blood
- Year
- 2013
- Identifier
- PMID 23637127 DOI 10.1182/blood-2012-12-467068
- Verification
- verified – PubMed efetch 2026-10-26; Crossref works API 2026-10-26
- Retracted
- no
- Corrections
- none
- Extent checked
- abstract only
- Conflicts of interest and funding
Not stated in abstract.
2. Research question
Risks of venous thromboembolism and sepsis after splenectomy in ITP.
3. Study design and population
- Study design
- Cohort study – Retrospective cohort (California discharge data) of patients with immune thrombocytopenia
- Population
9976 patients with ITP, 1762 splenectomised
- Country
USA (California)
- Period
Not stated in abstract
- Sample size
9976 (1762 splenectomy)
- Inclusion and exclusion criteria
ITP diagnosis
4. Methods and endpoints
- Exposure / intervention
Splenectomy
- Comparator
ITP patients without splenectomy
- Endpoints
Abdominal VTE, VTE (DVT/PE), sepsis
- Statistical methods
Cumulative incidence; adjusted HR early (<90 d) and late (>=90 d)
5. Actual results
- Results
Abdominal VTE 1.6% vs 1%; VTE 4.3% vs 1.7%. Abdominal VTE HR 5.4 (2.3-12.5) early, 1.5 (0.9-2.6) late. VTE HR 5.2 (3.2-8.5) early and 2.7 (1.9-3.8) late. Sepsis 11.1% vs 10.1%; adjusted HR 3.3 (2.4-4.6) early and 1.6 or 3.1 late depending on comorbidities.
- Absolute risks
VTE cumulative incidence 4.3% vs 1.7%.
- Authors' conclusion
ITP patients after splenectomy are at increased risk of abdominal VTE, VTE and sepsis.
6. Strengths
- Disease-matched comparison (all ITP)
- Large cohort
7. Weaknesses
- Administrative data
- Residual confounding by severity
8. Risk of bias
- Orienting tool
- ROBINS-E
- Type of assessment
- simplified assessment (abstract only)
- Full formal assessment
- no
- Overall risk of bias
- some concerns
- Rationale
Comparison within the same disease reduces confounding by indication.
9. Assessment of the statistical interpretation
VTE absolute difference 2.6 points, NNH about 38 (stats/C-ORG-12_13_splenectomy.py).
10. Relevance to the specific claim
Shows a lasting VTE and sepsis excess after splenectomy compared with patients with the same disease.
11. Independent contrary findings
Rørholt 2017 (A-ORG-17): MI and pulmonary hypertension explained by underlying disease.
12. Transferability to Germany and Europe
US data; biology transferable.
13. Overall methodological judgement
Supports the VTE part of C-ORG-13 (late HR 2.7), within a disease-matched comparison.
| Multidimensional assessment | |
|---|---|
| Authenticity of the source | verified |
| Methodological quality | moderate |
| Risk of bias | some concerns |
| Precision of results | moderate |
| Directness | direct |
| Reproducibility | replicated |
| Consistency with the overall evidence | consistent |
| Regional transferability | high |
| Adequacy of the interpretation (by the archive) | not applicable |
14. Open questions
Very long-term (>10 years) VTE risk.