Individualized Multimodal Hemostasis Evaluation Pyramid (IMHOTEP)

NCT03555383 | Completed

• 1 other identifier: Semmelweis University
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the hemostatic changes defined as hemostasis reserve capacity (HRC) in the first perioperative 48 hours of bloodless liver transplanted patients.

Conditions

Blood Loss, Postoperative; Liver Transplant; Hemostatic Disorder

Keywords

bloodless transplantation; hemostasis reserve capacity; surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Length of Intensive Care Unit stay

  An expected average of 3 days

• Length of hospital stay

  An expected average of 2 weeks

Interventions

Coagulation factor levels DIAGNOSTIC_TEST

The minimal functional hemostasis reserve capacity are defined by triggers as hematocrit: 27%, platelets: 30 G/l, Fibrinogen (FI): 1g/l, FII-FV-FVII-FX: 30%, Antithrombin III: 40%, FXIII: 60% levels. The estimate blood volume methodology is used for to determine the amount of allowable blood loss in volume (ml) that does not require replacement based on current and trigger levels. The individualized pyramid of intervention defined as hemostasis reserve capacity are followed at every studied patient. All measurements and calculations are performed before liver transplantation (T1), at arrival on Intensive Care Unit (T2) and 12-24-48 hours after liver transplantation (T3-4-5).

Also known as: Calculation of hemostasis reserve capacity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients who underwent bloodless liver transplantation in Semmelweis University Department of Transplantation and Surgery

You may qualify if:

• All bloodless liver transplanted patients in Semmelweis University Department of Transplantation and Surgery will be included in the study

You may not qualify if:

• 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.

Sponsors & Collaborators

• Semmelweis University: lead

Study Sites (1)

Semmelweis University

Budapest, Pest County, 1082, Hungary

Location

Related Publications (10)

• 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. doi: 10.1093/bja/aew308.

  PMID: 27799175 BACKGROUND

• Bidlingmaier C, Olivieri M, Hutker 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.

  PMID: 28130047 BACKGROUND

• 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.

  PMID: 23385607 BACKGROUND

• 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.

  PMID: 27559005 BACKGROUND

• Gorlinger K. [Coagulation management during liver transplantation]. Hamostaseologie. 2006 Aug;26(3 Suppl 1):S64-76. German.

  PMID: 16953295 BACKGROUND

• 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.

  PMID: 24397345 BACKGROUND

• 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.

  PMID: 27473518 BACKGROUND

• 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, Lance MD, Pitarch JVL, Mallett S, Meier J, Molnar ZL, Rahe-Meyer N, Samama CM, Stensballe J, Van der Linden PJF, Wikkelso 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.

  PMID: 28459785 BACKGROUND

• 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, Bruyere F, Berger J, Ansieau JP, Salome F, Hubert J, Pfister C, Trifard F, Gigante M, Baumert H, Mejean 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.

  PMID: 24053412 BACKGROUND

• 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. No abstract available.

  PMID: 25022237 BACKGROUND

MeSH Terms

Conditions

Postoperative Hemorrhage; Hemostatic Disorders

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Leader

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: June 13, 2018
• Study Start: August 1, 2017
• Primary Completion: August 1, 2020
• Study Completion: August 31, 2020
• Last Updated: September 2, 2020

Record last verified: 2020-09

Locations

HU (1)