Table 3. Results From Hematology and SARS-CoV-2 Testing for Initial 12 Patients With Cerebral Venous Sinus Thrombosis and Thrombocytopenia Following Emergency Authorization Receipt of Ad26.COV2.S Vaccine—US, 2021a.
| Patient No. | Platelet nadir, ×103/µLb | D-dimer peak, µg/mLb | Fibrinogen nadir, mg/dLb | Initial | SARS-CoV-2 | Heparin-PF4 ELISA test results (optical density)b,c | Functional platelet assay test resultsc | ||
|---|---|---|---|---|---|---|---|---|---|
| INR | aPTT, s | Serology | Viral assay | ||||||
| 1 | 12 | >20.0 | 93 | 1.4 | 31 | Not done | Negative (PCR) | Not done | Not done |
| 2 | 69 | 1.1 | 166 | 1.2 | 22.3 | Nucleocapsid antibody negative | Negative (PCR) | Positive (1.2) | Negative SRA |
| 3 | 18 | 8.46 | 82 | 1.5 | 31.1 | Not done | Negative (PCR) | Positive (2.7) | Negative SRA |
| 4 | 127 | 5.45 | 240 | 1.1 | 31.2 | Not done | Negative (PCR) | Positive (3.0) | Negative SRA |
| 5 | 10 | 7.05 | 141 | 1.1 | 18.1 | Antibody negatived | Negative (PCR) | Positive (1.6) | Negative SRA |
| 6 | 13 | 112.07 | 59 | 1.3 | 34.5 | Spike antibody negative | Negative (PCR) | Positive (3.2) | Negative SRA, negative LIA |
| 7 | 64 | 7.84 | 77 | 1.2 | –e | Not done | Not done | Positive (1.4) | Not done |
| 8 | 90 | 6.7 | 239 | 0.9 | 28 | Not done | Negative (antigen) | Positive (2.3) | Negative SRA |
| 9 | 15 | >4 | 332 | 1.1 | 26.9 | Nucleocapsid antibody negative | Negative (PCR) | Positive (2.5) | Negative SRA |
| 10 | 9 | 13.47 | 128 | 1.2 | 24.1 | Not done | Negative (PCR) | Positive (2.2) | Not done |
| 11 | 102 | 41.71 | 206 | 1.2 | 30.2 | Not done | Negative (PCR) | Positive (2.6) | Negative SRA, negative LIA |
| 12 | 20 | 45.57 | 149 | –f | 26.4 | Not done | Negative (PCR) | Positive (2.1) | Positive SRA and PEA, negative LIA |
Abbreviations: aPTT, activated partial thromboplastin time; CVST, cerebral venous sinus thrombosis; DVT, deep vein thrombosis; ELISA, enzyme-linked immunosorbent assay; INR, international normalized ratio; LIA, latex immunoturbidimetric assay; PCR, polymerase chain reaction; PEA, P-selectin expression assay; PF4, platelet factor 4; SRA, serotonin release assay.
Conversion factors: To convert platelet counts to cells/μL, multiply values by 1000.
Data are as of April 21, 2021. No patient received heparin prior to the detection of thrombocytopenia.
Reference range may vary by laboratory; representative ranges include the following: D-dimer, <0.5 µg/mL; fibrinogen, 200-400 mg/dL; heparin-PF4 ELISA optical density, 0-0.499 (each integer unit equals a 10-fold increase in signal intensity); platelets, 150-450 ×103/µL.
See Table 2 for more details.
Information was not available to distinguish whether antinucleocapsid or anti-spike SARS-CoV-2 antibodies were assessed.
The initial PTT value in this patient was obtained when the patient had already received anticoagulation.
The initial INR value in this patient was obtained when the patient had already received anticoagulation.