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

NCT05148650 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2021-12-08

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Standard laboratory coagulation tests and rotational thromboelastometry measurements

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.

Sponsors & Collaborators

  • Medical University of Silesia

    lead OTHER

Principal Investigators

  • Łukasz J Krzych, Professor · Faculty of Medical Sciences in Katowice, Medical University of Silesia

  • Agnieszka Wiórek, MD · Faculty of Medical Sciences in Katowice, Medical University of Silesia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-16
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05148650 on ClinicalTrials.gov