Clinical trial NCT06484231: Evaluation of the Effectiveness of Prophylactic LMWH by Thromboelastography
Official title: Evaluation of the Effectiveness of Prophylactic Low Molecular Weight Heparin by Thromboelastography in Patients Who Underwent Lobectomy Due to Malignancy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Malignancy
Keywords: malignancy
lobectomy
prophylaxis
thromboelastography
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent lobectomy due to malignancy

Brief summary: This study aims to evaluate the necessity and effectiveness of using low molecular weight heparin (LMWH) for prophylaxis in the postoperative period in patients who underwent lobectomy due to malignancy, using thromboelastography.Blood samples taken from the patients before low molecular weight heparin prophylaxis (preoperative), before prophylaxis in the postoperative period (postoperative day 1) and after the start of postoperative prophylaxis (postoperative day 3) will be examined by thromboelastography.

Detailed description: General characteristics of the patients such as age, gender, presence of comorbidities, smoking, type of operation and approach applied, operation duration, TEG measurements and postoperative complication development were recorded with case forms.

Eligibility criteria: Inclusion Criteria:

* Patients who underwent lobectomy with thoracotomy or videothoracoscopy (VATS) due to malignancy (primary or secondary lung cancer)

Exclusion Criteria:

* Patients with a known diagnosis of bleeding or coagulation disorders
* Patients receiving anticoagulant and antiplatelet therapy in the preoperative period
* Patients who developed perioperative bleeding and therefore underwent perioperative blood and blood product replacement

Primary outcomes:
measure: r time
timeFrame: 24 months
measure: k time
timeFrame: 24 months
measure: maximum amplitude (MA)
timeFrame: 24 months
measure: angle a
timeFrame: 24 months
Secondary outcomes:
measure: complications
timeFrame: 24 months
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University Faculty of Medicine
state: Bornova
Study officials:
affiliation: Ege University Faculty of Medicine, Department of Thoracic Surgery
name: Gizem Kececi Ozgur
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moaad F, Zakhar B, Anton K, Moner M, Wisam S, Safy F, Igor W. Is LMWH Sufficient for Anticoagulant Prophylaxis in Bariatric Surgery? Prospective Study. Obes Surg. 2017 Sep;27(9):2331-2337. doi: 10.1007/s11695-017-2638-1.
citation: Mukai M, Oka T. Mechanism and management of cancer-associated thrombosis. J Cardiol. 2018 Aug;72(2):89-93. doi: 10.1016/j.jjcc.2018.02.011. Epub 2018 Mar 24.
citation: Wang Q, Ding J, Yang R. The venous thromboembolism prophylaxis in patients receiving thoracic surgery: A systematic review. Asia Pac J Clin Oncol. 2021 Oct;17(5):e142-e152. doi: 10.1111/ajco.13386. Epub 2020 Oct 2.
citation: Klein SM, Slaughter TF, Vail PT, Ginsberg B, El-Moalem HE, Alexander R, D'Ercole F, Greengrass RA, Perumal TT, Welsby I, Gan TJ. Thromboelastography as a perioperative measure of anticoagulation resulting from low molecular weight heparin: a comparison with anti-Xa concentrations. Anesth Analg. 2000 Nov;91(5):1091-5. doi: 10.1097/00000539-200011000-00009.
citation: Tekkesin N, Tekkesin M, Kaso G. Thromboelastography for the monitoring of the antithrombotic effect of low-molecular-weight heparin after major orthopedic surgery. Anatol J Cardiol. 2015 Nov;15(11):932-7. doi: 10.5152/akd.2014.5723.
citation: Van PY, Cho SD, Underwood SJ, Morris MS, Watters JM, Schreiber MA. Thrombelastography versus AntiFactor Xa levels in the assessment of prophylactic-dose enoxaparin in critically ill patients. J Trauma. 2009 Jun;66(6):1509-15; discussion 1515-7. doi: 10.1097/TA.0b013e3181a51e33.