Cirrhosis, Liver, Procedural Bleeding, Thrombocytopenia; Drugs
Conditions
Keywords
Cirrhosis, Thrombocytopenia
Brief summary
Thrombocytopenia is a frequent issue in patients with cirrhosis undergoing various types of procedures (e.g. liver biopsy, endoscopy and minor surgical interventions). Thrombocytopenia \< 50\*10\^9/L increases the risk of perioperative and postoperative bleedning and might prevent patients with cirrhosis to undergo important procedures. Doptelet is a small molecular trombopoetin agonist, which results in proliferation and differentiation of megakaryocytes in the bone marrow resulting in increased levels of thrombocytes. It is given orally as a pill and is used to increase platelet count in patients with severe thrombocytopenia (\< 50\*10\^9/L) and cirrhosis and thus not to normalize platelet count. This study investigates the safety and efficacy of Doptelet in patients with cirrhosis and thrombocytopenia (\< 50\*10\^9/L) undergoing minor procedures like Transjugular Adjusted Liver Biopsy (TJALB) and gastroscopy.
Interventions
DRUGDoptelet Pill
40 mg or 60 mg Doptelet orally 10-13 days before planned procedure.
Sponsors
Hvidovre University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age: \>17 years and ≤80 years * ASA I-III * Patients who read, understood and signed informed consent. * Patients with a diagnosis of cirrhosis * Thrombocytopenia \<50\*109 * The patient is scheduled for one of the following procedures: Transjugular Adjusted Liver Biopsy (TJALB), gastroscopy or percutan paracentesis of ascites in the following month.
Exclusion criteria
* Patients who do not speak and understand Danish. * Patients who cannot cooperate within the trial. * Patients who did not sign an informed consent regardless of the cause. * Active drug abuse - to the discretion of the investigator. * Thrombocytes \>50\*10\^9 * Patients with hereditary trombolic diseases (e.g. Factor V Leiden, antithrombin deficiency, protein S and C deficiency, prothrombin G202110A mutation). * INR \> 1,7 * Ongoing infection verified by blood culture, clinical examination, and acute phase reactants (e.g. CRP)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 3 months postprocedural | Mortality, bleedning, blood clots, readmission, reoperation |
Contacts
Primary ContactChristian Snitkjær, M.B.
Backup ContactLine Molzen, M.D.
Outcome results
None listed