Effect of Human Plasma Protein Transfusion With and Without Crystalloids During Major Liver Resection Surgeries

NCT05033704 | Unknown

• 1 other identifier: MRC-01-18-256
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of acid-base and electrolyte changes after administration of commonly used colloid solutions (plasma protein fraction contains 5% albumin), and crystalloids (saline 0.9% and lactated ringers solutions) is the primary endpoint of this study. The secondary endpoints are to study dilution acidosis and changes in plasma volume induced by albumin versus crystalloids and their effect on tissue perfusion by randomizing patients into two groups where each group receives intraoperatively one type of the two fluids. Changes in acid-base, electrolytes, and dilution acidosis

Conditions

Coagulation; Intravascular; Fluid Electrolyte Disorders

Keywords

Human Plasma Protein; Crystalloids; Liver Resection Surgeries

Outcome Measures

Primary Outcomes (3)

• Base deficit

  The primary end point of the study will be changes in base deficit in the two groups

  Intra-operative at the end of the four stages of liver resection

• Strong Ion difference

  The primary end point of the study will be changes in strong ion difference in the two groups

  Intra-operative time at the end of four stages of liver resection

• Intra-vascular Albumin content

  The primary end point of the study will be changes in intra-vascular albumin mass in the two groups

  Intra-operative time at the end of the four stages of liver resection

Secondary Outcomes (4)

• Kidney functions

  Urine out put at the end of surgery and postoperative day one serum creatinine

• Total blood loss

  End of surgery blood loss

• Changes in coagulation using Thromboelastogram

  At the the end of resection phase and end of surgery

• Tissue perfusion index

  The four intra-operative stages of liver resection

Study Arms (2)

(Group A)

EXPERIMENTAL

Twenty-four of the 48 patients will receive an intraoperative intravenous infusion of 5% human plasma protein fraction PPF, (A group). PPF 5% "Octapharma 5 %" is a colloid solution containing (47.6-52.5% proteins, of which 45.6-52.5 gm/L albumin and 142.5-157.5 mmol/L sodium). Fluids will be given targeting euvolemic state which is defined as central venous pressure (CVP) 5-10 mmHg or Stroke volume variation (SVV) of ≤ 13%. Central venous pressure (CVP) CVP of -1 to 1 mmHg or Stroke volume variation (SVV) of 18-21% (12) will be targeted during transaction times. The transfusion trigger will be Hemoglobin of ≤8 gm/dl.

Drug: 5% human plasma protein fraction (PPF)

(Group RS)

NO INTERVENTION

24 patients will receive an intraoperative intravenous infusion of crystalloids (0.9 % normal saline and/ or Lactated Ringer's solution) (RS group). Fluids will be given targeting euvolemic state which is defined as central venous pressure (CVP) 5-10 mmHg or Stroke volume variation (SVV) of ≤ 13%. Central venous pressure (CVP) CVP of -1 to 1 mmHg or Stroke volume variation (SVV) of 18-21% (12) will be targeted during transaction times. The transfusion trigger will be Hemoglobin of ≤8 gm/dl.

Interventions

5% human plasma protein fraction (PPF) DRUG

Infusion of 5% human plasma protein fraction PPF. PPF 5% "Octapharma 5 %" is a colloid solution containing (47.6-52.5% proteins, of which 45.6-52.5 gm/L albumin and 142.5-157.5 mmol/L sodium).

Also known as: 5% Human Albumen

(Group A)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• Not allergic to PPF5%, NS and RL,
• No morphological or functional cardiac valve/s changes, cardiac ischemia, significant arrhythmias or in failure,
• Patients with normal liver function tests before surgery and has no chronic active liver disease,
• Patients with normal kidney functions.

You may not qualify if:

• Patients with cardiac disease,
• Kidney disease,
• Liver dysfunction,
• Those who receive additional blood products other than PRBCs.

Sponsors & Collaborators

• Hamad Medical Corporation: lead

Study Sites (1)

Hamad Medical Corporation

Doha, Baladīyat ad Dawḩah, 3050, Qatar

RECRUITING

Related Publications (15)

• Janeway, C. A.

  BACKGROUND

• Greasley L, Russell RJ. Albumin and its role in trauma resuscitation. J R Army Med Corps. 2005 Jun;151(2):65-8. doi: 10.1136/jramc-151-02-01. No abstract available.

  PMID: 16097108 BACKGROUND

• Ashraf S. Hasanin, Fatma M.A. Mahmoud, Hossam M. Soliman. Factors affecting acid base status during hepatectomy in cirrhotic patients. Egyptian Journal of Anesthesia (2013) 29, 305-310).

  BACKGROUND

• Semin Thromb Hemost 1980; 6(2): 85-120 DOI: 10.1055/s-2007-1005097

  RESULT

• Peters T Jr. Serum albumin. Adv Protein Chem. 1985;37:161-245. doi: 10.1016/s0065-3233(08)60065-0. No abstract available.

  PMID: 3904348 RESULT

• Quinlan GJ, Martin GS, Evans TW. Albumin: biochemical properties and therapeutic potential. Hepatology. 2005 Jun;41(6):1211-9. doi: 10.1002/hep.20720. No abstract available.

  PMID: 15915465 RESULT

• Tullis JL. Albumin. 1. Background and use. JAMA. 1977 Jan 24;237(4):355-60 CONTD. doi: 10.1001/jama.237.4.355. No abstract available.

  PMID: 576167 RESULT

• Liumbruno GM, Bennardello F, Lattanzio A, Piccoli P, Rossettias G; Italian Society of Transfusion Medicine and Immunohaematology (SIMTI). Recommendations for the use of albumin and immunoglobulins. Blood Transfus. 2009 Jul;7(3):216-34. doi: 10.2450/2009.0094-09. No abstract available.

  PMID: 19657486 RESULT

• Pusey C, Dash C, Garrett M, Gascoigne E, Gesinde M, Gillanders K, Wallington T. Experience of using human albumin solution 4.5% in 1195 therapeutic plasma exchange procedures. Transfus Med. 2010 Aug 1;20(4):244-9. doi: 10.1111/j.1365-3148.2010.00999.x. Epub 2010 Mar 11.

  PMID: 20230532 RESULT

• Dill DB, Costill DL. Calculation of percentage changes in volumes of blood, plasma, and red cells in dehydration. J Appl Physiol. 1974 Aug;37(2):247-8. doi: 10.1152/jappl.1974.37.2.247. No abstract available.

  PMID: 4850854 RESULT

• Goodkin DA, Raja RM, Saven A. Dilutional acidosis. South Med J. 1990 Mar;83(3):354-5. doi: 10.1097/00007611-199003000-00029.

  PMID: 2315790 RESULT

• Mathes DD, Morell RC, Rohr MS. Dilutional acidosis: is it a real clinical entity? Anesthesiology. 1997 Feb;86(2):501-3. doi: 10.1097/00000542-199702000-00028. No abstract available.

  PMID: 9054271 RESULT

• Dunki-Jacobs EM, Philips P, Scoggins CR, McMasters KM, Martin RC 2nd. Stroke volume variation in hepatic resection: a replacement for standard central venous pressure monitoring. Ann Surg Oncol. 2014 Feb;21(2):473-8. doi: 10.1245/s10434-013-3323-9. Epub 2013 Oct 23.

  PMID: 24150192 RESULT

• Norberg A, Rooyackers O, Segersvard R, Wernerman J. Leakage of albumin in major abdominal surgery. Crit Care. 2016 Apr 26;20(1):113. doi: 10.1186/s13054-016-1283-8.

  PMID: 27117323 RESULT

• Nadler SB, Hidalgo JH, Bloch T. Prediction of blood volume in normal human adults. Surgery. 1962 Feb;51(2):224-32. No abstract available.

  PMID: 21936146 RESULT

MeSH Terms

Conditions

Thrombosis

Interventions

plasma protein fraction

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yasser Hammad, M.D.

  Hamad Medical Corporation - HMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yasser Hammad, M.D.

CONTACT

+97433000198; yhammad@hamad.qa

Nabil Shallik, M.D.

CONTACT

+97455439264; nshallik@hamad.qa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: September 5, 2021
• Study Start: September 9, 2019
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: September 5, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Directly after IRB approval.
• Access Criteria: Website

Locations

QA (1)