Impact of Balanced Crystalloid and Colloid Infusion on Haemostasis in Healthy Male Volunteers

NCT05148650 | Unknown

• 1 other identifier: KNW/0022/KB1/159/II/15161819
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The project focuses on perioperative bleeding that requires transfusion of blood products and supplementation of intravascular volume with crystalloids and colloids. The implemented fluid therapy affects coagulation and fibrinolysis, depending on the type of fluid used in an intravenous infusion. Massive haemorrhage significantly impacts the perioperative period and postoperative quality of life and requires individualized therapy, rending the ongoing project relevant from the perspective of the patients.

Conditions

Perioperative Hemorrhage; Dilutional Coagulopathy

Keywords

perioperative hemorrhage; fluid therapy; fluid resuscitation; rotational thromboelastometry; goal-directed therapy; dilutional coagulopathy

Outcome Measures

Primary Outcomes (6)

• Rotational thromboelastometry (ROTEM) viscoelastic point-of-care coagulation measurements before and after balanced crystalloid infusion

  EXTEM, INTEM, FIBTEM assays: * A10: clot firmness amplitude measured after 10 minutes (mm) * A20: clot firmness amplitude measured after 20minutes (mm) * AA: alpha angle (\*) * CFT: clot forming time (s) * CT: clotting time (s) * MCE: maximum clot elasticity * MCF: maximum clot firmness (mm) * ML: maximum lysis (%)

  60 minutes

• Rotational thromboelastometry (ROTEM) viscoelastic point-of-care coagulation measurements before and after synthetic colloid infusion

  EXTEM, INTEM, FIBTEM assays: * A10: clot firmness amplitude measured after 10 minutes (mm) * A20: clot firmness amplitude measured after 20minutes (mm) * AA: alpha angle (\*) * CFT: clot forming time (s) * CT: clotting time (s) * MCE: maximum clot elasticity * MCF: maximum clot firmness (mm) * ML: maximum lysis (%)

  60 minutes

• Standard laboratory tests reporting coagulation status before and after balanced crystalloid infusion

  * fibrinogen concentration (mg/dl) * APTT: activated partial thromboplastin time (s) * PT: prothrombin time (s) * INR: international normalized ratio * PLT: platelet count (10\^3/ul) * MPV: mean platelet volume (fl) * PDW: platelet distribution width (fl) * P-LCR: platelet-large cell ratio (%)

  60 minutes

• Standard laboratory tests reporting coagulation status before and after synthetic colloid infusion

  * fibrinogen concentration (mg/dl) * APTT: activated partial thromboplastin time (s) * PT: prothrombin time (s) * INR: international normalized ratio * PLT: platelet count (10\^3/ul) * MPV: mean platelet volume (fl) * PDW: platelet distribution width (fl) * P-LCR: platelet-large cell ratio (%)

  60 minutes

• Standard laboratory tests reporting fibrinolysis status before and after balanced crystalloid infusion

  \- D-dimer concentration (ug/ml)

  60 minutes

• Standard laboratory tests reporting fibrinolysis status before and after synthetic colloid infusion

  \- D-dimer concentration (ug/ml)

  60 minutes

Secondary Outcomes (1)

• Safety outcomes after crystalloid and colloid infusion

  28 days

Study Arms (2)

Crystalloid infusion

EXPERIMENTAL

Intravenous (IV) transfusions were performed of a 20ml/kg of a balanced crystalloid solution (Optilyte®, Fresenius Kabi). The infusions were performed through an intravenous cannula (18G) inserted into a vein in the antecubital fossa on the non-dominant limb at 1000 ml/h

Diagnostic Test: Standard laboratory coagulation tests and rotational thromboelastometry measurements

Colloid infusion

EXPERIMENTAL

Intravenous (IV) transfusions were performed of a 20ml/kg of gelatin 26,500 Da (Geloplasma®, Fresenius Kabi). The infusions were performed through an intravenous cannula (18G) inserted into a vein in the antecubital fossa on the non-dominant limb at 1000 ml/h

Diagnostic Test: Standard laboratory coagulation tests and rotational thromboelastometry measurements

Interventions

Standard laboratory coagulation tests and rotational thromboelastometry measurements DIAGNOSTIC_TEST

Blood for coagulation tests (thromboelastometry, aPTT, PT, INR, fibrinogen concentration, D dimers) and blood morphology was collected just before and immediately after the fluid infusion. With the use of a vacuum system, 20 ml of blood was collected through an IV cannula. The first 5 ml of blood were disposed of due to the possible interference with vascular stasis and fluid infusion on the measurements results. Functional tests of coagulation were analysed through ROTEM. ROTEM coagulation analysis was carried out using a ROTEM delta analyzer (Tem Innovations GmbH, Munich, Germany), and assays were allowed to run for 60 minutes. Assays were run immediately after blood sampling to minimize a preanalytical error. Three ROTEM assays were run simultaneously, INTEM, EXTEM, and FIBTEM.

Colloid infusion; Crystalloid infusion

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male volunteers aged 18-30 years
• The American Society of Anaesthesiologists Physical Status (ASA PS) I risk class
• Must be able to give informed consent

You may not qualify if:

• Female sex
• Blood type O
• A positive history of any acute diseases in the last four weeks
• Chronic diseases
• Any diagnosed haemostatic disorders
• History of anticoagulation
• Any known bleeding diathesis
• Any pharmacotherapy in the previous week
• Participants were informed about the prohibition of drinking alcohol, excessive exercise, and stress on the day before blood sampling

Sponsors & Collaborators

• Medical University of Silesia: lead

Study Sites (1)

Department of Anaesthesiology and Intensive Care, Faculty of Medical Sciences in Katowice, Medical University of Silesia in Katowice

Katowice, Silesian Voivodeship, 40-752, Poland

Location

Related Publications (1)

• Wiorek A, Mazur PK, Niemiec B, Krzych LJ. Association between Functional Parameters of Coagulation and Conventional Coagulation Tests in the Setting of Fluid Resuscitation with Balanced Crystalloid or Gelatine: A Secondary Analysis of an In Vivo Prospective Randomized Crossover Study. J Clin Med. 2022 Jul 14;11(14):4065. doi: 10.3390/jcm11144065.

  PMID: 35887829 DERIVED

Study Officials

• Łukasz J Krzych, Professor

  Faculty of Medical Sciences in Katowice, Medical University of Silesia

  STUDY DIRECTOR

• Agnieszka Wiórek, MD

  Faculty of Medical Sciences in Katowice, Medical University of Silesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: December 8, 2021
• Study Start: February 16, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: December 8, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)