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Abstract
Introduction Thrombocytopaenia is a common entity in CLD with or without cirrhosis. Liver biopsy is the gold standard for diagnosis and prognosis of CLD. Platelet count is imperative before percutaneous liver biopsy. Platelet transfusion requires over night hospitalisation with transfusion associated morbidities and cost burden. Romiplostim, a fusion protein TPO, is a hormone that regulates platelet production approved in idiopathic thrombocytopenic purpura (ITP). This study evaluates single use of Romiplostim 2 week prior to liver biopsy to avoid biopsy related morbidity and mortality.
Methods 65 patients (n=65), (mean age: 56 years; M:F-2:1) with Hepatitis C: 37/65 (57%); hepatitis B (HBV) 7 (15.5%), Alcoholic Cirrhosis 10 (15%); Non-Alcoholic steato-hepatits (NASH) 3 (5%), Primary biliary cirrhosis (PBC) 6 (9%) with pre-biopsy mean platelet count 77k; Mean MELD score 20, mode fibrotic score F4 were randomised in blinded fashion into three groups: Group A (n=18), received seven units of platelet transfusion at night for the morning procedure. Group B (n=23) received Romiplostim 500 μg sc given 2 weeks prior to the procedure, and Group C (n=24) Elthrombopag orally 75 mg/day for 2 weeks. PLT-CT was repeated 2 h prior and Post-biopsy in 4 weeks in all groups. Inclusion criteria: CLD with thrombocytopaenia.
| BL PLT (×109/l) | PreOp PLT (×109/l) | 4 wk PostOp (×109/l) | Mean Chg BL to PreOp (×109/l) | Mean Chg PreOp to 4 wk PostOp (×109/l) | Mean Chg BL to 4 wk PostOp (×109/l) | Cost (WAC) | |
| PLT TRF | 56.9* | 183.8 | 85.9 | 126.8 | −97.9 | 28.9 | $7500 |
| Romiprostim | 58.7* | 232† | 366.2‡ | 173.3† | 192.9‡ | 307.5‡ | $2284 |
| Elthrombopag | 54.5* | 189.9* | 173.6§ | 135.4* | −16.3§ | 119.1§ | $2991 |
*p=ND vs PLT.
†p<0.05 vs PLT TRF and Elthrombopag.
‡p<0.001 vs PLT TRF and Elthrombopag.
§p<0.001 vs PLT TRF.
Conclusion This pilot study demonstrates that single use of Romiplostim is efficacious, cost-effective, and safe without side effects for liver biopsy with severe thrombocytopaenia. Single use of Romiplostim should be considered before Trans jugular intra-hepatic porto-systemic shunts or portal haemodynamic procedures and prior to surgical interventions with severe thrombocytopaenia. A large randomised clinical trial is needed for further validation.
Competing interests None declared.