VALIDATION OF THE VIBe INTRAOPERATIVE BLEEDING SCALE IN LIVER SURGERY

Liver Cancer Clinical Trial

Official title:

VALIDATION OF THE VIBe INTRAOPERATIVE BLEEDING SCALE IN LIVER SURGERY. PROSPECTIVE AND MULTICENTRIC STUDY

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05369988
• Other study ID #: PI21-510
• Status: Not yet recruiting
• Start date: July 1, 2022
• Est. completion date: April 1, 2023

Study information

• Verified date: May 2022
• Source: Hospital Miguel Servet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Surgical hemostasis has become one of the fundamental principles for the advancement of surgery. The use of hemostatic agents is standard in many surgical specialties, although the lack of consensus or standardized classifications to determine intraoperative bleeding has led to their inappropriate selection on many occasions. The recommendations of international organizations highlight the need for a bleeding severity scale validated in clinical studies that allows selecting the hemostatic agent that best suits each case.

Description:

Surgical hemostasis has become one of the fundamental principles for the advancement of surgery. The use of hemostatic agents is standard in many surgical specialties, with greater use in major surgeries. Inadequate hemostasis significantly increases the risk of perioperative morbidity and mortality, healthcare costs and the use of resources. The need for hemostasis has led to the development of various topical hemostatic agents.

Clinical studies that have analyzed the use of topical hemostats have not used standardized definitions or classifications to determine the severity of intraoperative bleeding, partly due to a lack of consensus on the definition of the severity of bleeding and partly due to the severity of bleeding. lack of requirements to do so. This has led many surgeons to an inadequate selection of hemostats for different bleeding situations, the results being inefficient. Using standardized criteria, the results of clinical studies can be compared to determine the effectiveness of hemostatic agents.

The FDA (Food and Drug Administration) requires the use of a bleeding severity scale validated in clinical studies investigating hemostatic agents. The VIBe (Validated Intraoperative Bleeding Scale) for intraoperative bleeding was developed in 2017.This scale has been validated by a large number of expert surgeons from all specialties, but in an animal model. However, it has not yet been clinically validated.

Liver surgery is one of the surgeries where intraoperative bleeding is more important. In Spain, around 5000 liver resections are performed annually, not including liver transplants. It is, therefore, a perfect framework to validate the applicability of the VIBe scale of severity of intraoperative bleeding.

In order to evaluate the viability of a prospective clinical study in liver surgery, a parallel project has been worked on based on the evaluation of the applicability of the VIBe scale, carried out by liver surgeons by reviewing the original video recordings described in the VIBe scale. Forty-seven surgeons were selected from 10 medium-high-volume liver surgery centers, all of them reference centers (same centers that will participate in the prospective study). 5 of the 10 hospitals perform liver transplants. These centers have a mean reference population of 922,506 ± 225,603 patients. The mean number of major hepatectomies per year is 23 ± 16, the number of minor hepatectomies 56 ± 24, and the number of liver transplants 40 ±

27. 40.5% of all hepatectomies are performed by a minimally invasive approach.

The 47 surgeons viewed 14 videos used by Lewis et al. for the validation of the original VIBe scale. 63.3% of the participating surgeons were men with a mean age of 41.6 years. 17% were unit / department heads and 83% were senior surgeons. The mean experience was 9.3 years, and the majority were experts (21.3%) or with advanced knowledge (53.2%) in minimally invasive surgery. Only 23.4% had prior knowledge of the VIBe scale, but all surgeons used hemostats in their daily clinical practice. The VIBe scale achieved a mean intraobserver agreement of 0.985 and an interobserver agreement of 0.929, neither of which was influenced by the experience of the surgeon or the volume of surgeries per year. The average rating for all videos was 67% correct, in line with the original validation. Most surgeons considered that the scale represented the range of severity of bleeding in their procedures (91%), relevant to assess intraoperative hemostasis in clinical studies (96%) and clinical practice (87.2%), useful in CMI (96%), and also to differentiate hemostatic agents (81%).

With these preliminary data, based on the video classification exercise, we can conclude that the VIBe scale is useful for the assessment of the severity of bleeding performed by liver surgeons. Therefore, an assessment of the severity of intraoperative bleeding using the scale in actual liver surgery is feasible. Our goal is to publish these results independently before starting the clinical observation record.

To evaluate the clinical applicability, a prospective registry of patients undergoing liver surgery has been designed in the 10 selected Spanish centers. Demographic and preoperative, intraoperative and postoperative data will be collected. Intraoperative bleeding will be measured according to the VIBe scale at two points of the surgical intervention: the maximum bleeding and at the end of the surgery. Data will be collected on the type of hemostatic or surgical strategy that has been carried out to correct bleeding (i.e. pressure, suture, coagulation, hemostatic, etc.) and other data related to bleeding (blood loss, units of blood transfused, etc.). Postoperative complications will be classified according to the Clavien-Dindo classification and the CCI (Comprehensive Complication Index). Major complications are defined as those with a Clavien-Dindo ≥ IIIa. The classification of liver failure and postoperative bleeding are defined following the International Study Group of Liver Liver Surgery (ISGLS) classifications. At the end of the registration a statistical analysis of the data will be performed to determine the applicability and usefulness of the VIBe scale in liver surgery, as well as to determine the relationship between the type of bleeding, the hemostatic measurements used, the success rate of the hemostatic measurements, and the bleeding-related complications.

Despite the extensive literature published on liver surgery, there is no scientific evidence that allows us to have validated scalds that quantify the severity of intraoperative bleeding and, consequently, select which is the best hemostatic procedure that is adapted to each case. All of this has repercussions on patient safety, increased postoperative morbidity and mortality, as well as the inappropriate use of healthcare resources and consequently increased costs.

This prospective multicenter study in national centers that perform Liver Surgery aims to evaluate and validate a scale that allows quantifying intraoperative bleeding in liver surgery.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 259
• Est. completion date: April 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients age = 18, scheduled for liver surgery, by open or minimally invasive approach, regardless of diagnosis;

• ASA score <4

• They have signed the informed consent.

Exclusion Criteria:

• Patients with contraindications for liver surgery

• Emergency surgical interventions

• Patients <18 years

• Patients who have not signed the informed consent.

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Hemorrhage
• Liver Cancer
• Liver Metastases

Locations

Country	Name	City	State
Spain	Daniel Aparicio Lopez	Zaragoza
Spain	Mario Serradilla Martin	Zaragoza

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Miguel Servet	Asociación Española de Cirujanos

Country where clinical trial is conducted

Spain, 

References & Publications (16)

American Society of Anesthesiologists Task Force on Perioperative Blood Management. Practice guidelines for perioperative blood management: an updated report by the American Society of Anesthesiologists Task Force on Perioperative Blood Management*. Anest — View Citation

Christensen MC, Krapf S, Kempel A, von Heymann C. Costs of excessive postoperative hemorrhage in cardiac surgery. J Thorac Cardiovasc Surg. 2009 Sep;138(3):687-93. doi: 10.1016/j.jtcvs.2009.02.021. Epub 2009 Apr 19. — View Citation

Dimick JB, Chen SL, Taheri PA, Henderson WG, Khuri SF, Campbell DA Jr. Hospital costs associated with surgical complications: a report from the private-sector National Surgical Quality Improvement Program. J Am Coll Surg. 2004 Oct;199(4):531-7. — View Citation

Filipescu DC, Stefan MG, Valeanu L, Popescu WM. Perioperative management of antiplatelet therapy in noncardiac surgery. Curr Opin Anaesthesiol. 2020 Jun;33(3):454-462. doi: 10.1097/ACO.0000000000000875. Review. — View Citation

Fischer CP, Bochicchio G, Shen J, Patel B, Batiller J, Hart JC. A prospective, randomized, controlled trial of the efficacy and safety of fibrin pad as an adjunct to control soft tissue bleeding during abdominal, retroperitoneal, pelvic, and thoracic surg — View Citation

Kommu SS, McArthur R, Emara AM, Reddy UD, Anderson CJ, Barber NJ, Persad RA, Eden CG. Current Status of Hemostatic Agents and Sealants in Urologic Surgical Practice. Rev Urol. 2015;17(3):150-9. — View Citation

Levy JH, Dutton RP, Hemphill JC 3rd, Shander A, Cooper D, Paidas MJ, Kessler CM, Holcomb JB, Lawson JH; Hemostasis Summit Participants. Multidisciplinary approach to the challenge of hemostasis. Anesth Analg. 2010 Feb 1;110(2):354-64. doi: 10.1213/ANE.0b0 — View Citation

Lewis KM, Li Q, Jones DS, Corrales JD, Du H, Spiess PE, Lo Menzo E, DeAnda A Jr. Development and validation of an intraoperative bleeding severity scale for use in clinical studies of hemostatic agents. Surgery. 2017 Mar;161(3):771-781. doi: 10.1016/j.sur — View Citation

Menkis AH, Martin J, Cheng DC, Fitzgerald DC, Freedman JJ, Gao C, Koster A, Mackenzie GS, Murphy GJ, Spiess B, Ad N. Drug, devices, technologies, and techniques for blood management in minimally invasive and conventional cardiothoracic surgery: a consensu — View Citation

Schuhmacher C, Pratschke J, Weiss S, Schneeberger S, Mihaljevic AL, Schirren R, Winkler M, Emmanouilidis N. Safety and effectiveness of a synthetic hemostatic patch for intraoperative soft tissue bleeding. Med Devices (Auckl). 2015 Mar 31;8:167-74. doi: 1 — View Citation

Shander A, Van Aken H, Colomina MJ, Gombotz H, Hofmann A, Krauspe R, Lasocki S, Richards T, Slappendel R, Spahn DR. Patient blood management in Europe. Br J Anaesth. 2012 Jul;109(1):55-68. doi: 10.1093/bja/aes139. Epub 2012 May 24. — View Citation

Shander A. Financial and clinical outcomes associated with surgical bleeding complications. Surgery. 2007 Oct;142(4 Suppl):S20-5. Review. — View Citation

Society of Thoracic Surgeons Blood Conservation Guideline Task Force, Ferraris VA, Brown JR, Despotis GJ, Hammon JW, Reece TB, Saha SP, Song HK, Clough ER; Society of Cardiovascular Anesthesiologists Special Task Force on Blood Transfusion, Shore-Lesserso — View Citation

Stokes ME, Ye X, Shah M, Mercaldi K, Reynolds MW, Rupnow MF, Hammond J. Impact of bleeding-related complications and/or blood product transfusions on hospital costs in inpatient surgical patients. BMC Health Serv Res. 2011 May 31;11:135. doi: 10.1186/1472 — View Citation

Wright JD, Ananth CV, Lewin SN, Burke WM, Siddiq Z, Neugut AI, Herzog TJ, Hershman DL. Patterns of use of hemostatic agents in patients undergoing major surgery. J Surg Res. 2014 Jan;186(1):458-66. doi: 10.1016/j.jss.2013.07.042. Epub 2013 Aug 13. — View Citation

Wright Jr. JR, Schachar, NS. Necessity is the mother of invention: William Stewart Halsted's addiction and its influence on the development of residency training in North America. Can J Surg. 2020 Jan 16;63(1):E13-E19. doi: 10.1503/cjs.003319. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To validate the VIBe scale.	To validate the VIBe scale for intraoperative bleeding in liver surgery.	30 days
Secondary	Usefulness of the scale	Assess the repeatability, reproducibility and usefulness of the scale in this type of surgery.	30 days
Secondary	Determine the relationship between type of bleeding and hemostatic used, the success rate of hemostatic measurements, and complications related to bleeding.	Determine the relationship between type of bleeding and hemostatic used, the success rate of hemostatic measurements, and complications related to bleeding.	30 days