Haemostasis Management of Abdominal Aortic Procedures

NCT03426839 | Unknown

• 1 other identifier: Upecs
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Comparative study on efficacy of haemostatic therapy guided either by standard laboratory coagulation parameters or point-of-care testing in patients undergoing vascular surgical procedures. We investigate the amount of perioperative bleeding and the number of blood product used. Inclusion criteria Patients scheduled for elective and acute open aorta surgery or undergoing acute aorta surgery with minimally invasive techniques and were provided treatment in the operating theatre and/or ICU attached to perioperative care, they must be at least 18 years of age and written informed consent was obtained from the patient or his/her legal representative. Randomisation technique Patients will be randomly assigned to each of two treatment groups using sealed envelopes. In group 1 (G1) haemostasis strategy guided by conventional coagulation tests, while in group 2 (G2) transfusion algorithms guided by point-of-care (POC) tests will be carried out. Sampling techniques and measurements For assessment of monitored parameters shall be used arterial or venous blood depending on the catheter placed preoperatively. In case of the above mentioned vascular surgical procedures, all patients will receive arterial cannula routinely, and, depending on the extension of procedure, as appropriate, a central venous catheter will be inserted as well. Sampling in the patient groups shall be performed as follows:

• pre- and postoperative evaluation of standard laboratory parameters in all patients
• evaluation of standard laboratory parameters and arterial Astrup test during and after surgery in group 1, if the blood loss volume reaches 1,5 ml/kg/minute during 20 minutes
• in case of elective surgery: thromboelastometry and arterial Astrup test during and after surgery in group 2 if the blood loss volume reaches 1,5 ml/kg/minute during 20 minutes
• in case of acute surgery: thromboelastometry and arterial Astrup test before, during and after surgery in group 2
• in case of positive anamnesis, preoperative platelet aggregation test in both groups Besides the above samplings, routine lab tests (blood gas, blood count, sodium (Na), potassium (K), parameters of renal and liver function, clotting and inflammation, lactic acid, blood sugar) will be performed every day as usual during intensive therapy.

Conditions

Abdominal Aortic Aneurism; Abdominal Aortic Rupture; Perioperative/Postoperative Complications; Surgical Blood Loss

Keywords

hemostatic techniques; perioperative hemorrhage; platelet function test; point of care technology; thromboelastometry; vascular surgical procedures

Outcome Measures

Primary Outcomes (2)

• The number of blood products used

  24 hours

• Amount of perioperative bleeding

  24 hours

Study Arms (2)

Conventional group

ACTIVE COMPARATOR

In the conventional group (group 1) haemostasis strategy guided by conventional coagulation tests will be carried out.

Diagnostic Test: Coagulation tests

Point of care group

ACTIVE COMPARATOR

In the point of care group (group 2) transfusion algorithms guided by point-of-care (POC) tests will be applied. We will use viscoelastic thromboelastometry and impedance aggregometry.

Diagnostic Test: Coagulation tests

Interventions

Coagulation tests DIAGNOSTIC_TEST

Also known as: Conventional coagulation tests, Point of care coagulation tests

Conventional group; Point of care group

Eligibility Criteria

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

You may qualify if:

• patients scheduled for elective and acute open aorta surgery or undergoing acute aorta surgery with minimally invasive techniques and were provided treatment in the operating theatre and/or ICU attached to perioperative care
• they must be at least 18 years of age
• written informed consent was obtained from the patient or his/her legal representative.

You may not qualify if:

• patients under 18 years of age
• informed consent not provided
• congenital coagulation factor deficiency
• congenital thrombocytopathy

Sponsors & Collaborators

• University of Pecs: lead

Related Publications (1)

• 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

MeSH Terms

Conditions

Postoperative Complications; Blood Loss, Surgical

Interventions

Blood Coagulation Tests

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hemorrhage; Intraoperative Complications

Intervention Hierarchy (Ancestors)

Hematologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomly assigned to each of two treatment groups using sealed envelopes: * Patient group 1: haemostasis strategy guided by conventional coagulation tests. * Patient group 2: transfusion algorithm guided by viscoelastic POC tests and algorithms.

Study Record Dates

• First Submitted: February 2, 2018
• First Posted: February 8, 2018
• Study Start: May 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 12, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share