Liver Transplant Clinical Trial
Official title:
Hemostasis Kinetics During Bloodless Liver Transplantation
Verified date | September 2020 |
Source | Semmelweis University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study evaluates the hemostatic changes defined as hemostasis reserve capacity (HRC) in the first perioperative 48 hours of bloodless liver transplanted patients.
Status | Completed |
Enrollment | 59 |
Est. completion date | August 31, 2020 |
Est. primary completion date | August 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - All bloodless liver transplanted patients in Semmelweis University Department of Transplantation and Surgery will be included in the study Exclusion Criteria: - Patients with: Required Red Blood Cells (RBC), Fresh Frozen Plasma (FFP) or platelets replacement in the perioperative first 48 hours, pediatric patients (age < 18 years) and acut liver failure patients. |
Country | Name | City | State |
---|---|---|---|
Hungary | Semmelweis University | Budapest | Pest Megye |
Lead Sponsor | Collaborator |
---|---|
Semmelweis University |
Hungary,
Baron DM, Metnitz PG, Fellinger T, Metnitz B, Rhodes A, Kozek-Langenecker SA. Evaluation of clinical practice in perioperative patient blood management. Br J Anaesth. 2016 Nov;117(5):610-616. — View Citation
Bidlingmaier C, Olivieri M, Hütker S, Dietl S, Kurnik K. Perioperative management of hemostasis in children and adolescents. Blood Cells Mol Dis. 2017 Sep;67:91-95. doi: 10.1016/j.bcmd.2017.01.009. Epub 2017 Jan 16. Review. — View Citation
Gibon E, Courpied JP, Hamadouche M. Total joint replacement and blood loss: what is the best equation? Int Orthop. 2013 Apr;37(4):735-9. doi: 10.1007/s00264-013-1801-0. Epub 2013 Feb 6. Review. — View Citation
Goel R, Cushing MM, Tobian AA. Pediatric Patient Blood Management Programs: Not Just Transfusing Little Adults. Transfus Med Rev. 2016 Oct;30(4):235-41. doi: 10.1016/j.tmrv.2016.07.004. Epub 2016 Aug 1. Review. — View Citation
Görlinger K. [Coagulation management during liver transplantation]. Hamostaseologie. 2006 Aug;26(3 Suppl 1):S64-76. Review. German. — View Citation
Kahvecioglu D, Erdeve O, Alan S, Cakir U, Yildiz D, Atasay B, Arsan S. The impact of evaluating platelet transfusion need by platelet mass index on reducing the unnecessary transfusions in newborns. J Matern Fetal Neonatal Med. 2014 Nov;27(17):1787-9. doi: 10.3109/14767058.2013.879708. Epub 2014 Feb 3. — View Citation
Keir AK, Stanworth SJ. Neonatal Plasma Transfusion: An Evidence-Based Review. Transfus Med Rev. 2016 Oct;30(4):174-82. doi: 10.1016/j.tmrv.2016.07.001. Epub 2016 Jul 9. Review. — View Citation
Kozek-Langenecker SA, Ahmed AB, Afshari A, Albaladejo P, Aldecoa C, Barauskas G, De Robertis E, Faraoni D, Filipescu DC, Fries D, Haas T, Jacob M, Lancé MD, Pitarch JVL, Mallett S, Meier J, Molnar ZL, Rahe-Meyer N, Samama CM, Stensballe J, Van der Linden PJF, Wikkelsø AJ, Wouters P, Wyffels P, Zacharowski K. Management of severe perioperative bleeding: guidelines from the European Society of Anaesthesiology: First update 2016. Eur J Anaesthesiol. 2017 Jun;34(6):332-395. doi: 10.1097/EJA.0000000000000630. — View Citation
Lang H, Mouracade P, Gimel P, Bernhard JC, Pignot G, Zini L, Crepel M, Rigaud J, Salomon L, Bellec L, Vaessen C, Roupret M, Jung JL, Mourey E, Martin X, Bigot P, Bruyère F, Berger J, Ansieau JP, Salome F, Hubert J, Pfister C, Trifard F, Gigante M, Baumert H, Méjean A, Patard JJ. National prospective study on the use of local haemostatic agents during partial nephrectomy. BJU Int. 2014 May;113(5b):E56-61. doi: 10.1111/bju.12397. Epub 2013 Oct 31. — View Citation
Massicotte L, Denault AY, Thibeault L, Hevesi Z, Nozza A, Roy A. Relationship between conventional coagulation tests and bleeding for 600 consecutive liver transplantations. Transplantation. 2014 Jul 27;98(2):e13-5. doi: 10.1097/TP.0000000000000253. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of coagulation factor levels and hemostasis reserve capacity during bloodless liver transplantation from baseline till the second postoperative day | Based on coagulation factors measurements the allowable blood loss is calculated and defined as hemostasis reserve capacity till compulsory coagulation factor or blood products replacement is needed to avoid coagulopathic bleeding in the perioperative phase of liver transplantation. The changes of the measured coagulation factors and the hemostasis reserve capacity is counted at the different meaning points: baseline-before liver transplantation (T1), after successful liver transplantation at arrival on intensive care unit-ICU (T2) and postoperatively according to the graft function: 12 hours after liver transplantation (T3), 24 hours after liver transplantation (T4), 48 hours after liver transplantation (T5). | Participants will be followed preoperatively, postoperative 0,12, 24, 48. hours after liver transplantation | |
Secondary | Length of Intensive Care Unit stay | Participants will be followed for the duration of Intensive Care Unit stay | An expected average of 3 days | |
Secondary | Length of hospital stay | Participants will be followed for the duration of hospital stay | An expected average of 2 weeks |
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