NCT06484231

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 24, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 6, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 6, 2025

Completed
Last Updated

August 12, 2025

Status Verified

August 1, 2025

Enrollment Period

2 years

First QC Date

June 26, 2024

Last Update Submit

August 6, 2025

Conditions

Malignancy

Keywords

malignancylobectomyprophylaxisthromboelastography

Outcome Measures

Primary Outcomes (4)

  • r time

    'r time' value measured by thromboelastography

    24 months

  • k time

    'k time' value measured by thromboelastography

    24 months

  • maximum amplitude (MA)

    'MA' value measured by thromboelastography

    24 months

  • angle a

    'angle a' value measured by thromboelastography

    24 months

Secondary Outcomes (1)

  • complications

    24 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent lobectomy due to malignancy

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University Faculty of Medicine

Izmir, Bornova, 35100, Turkey (Türkiye)

Location

Related Publications (6)

  • 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.

    PMID: 28326488BACKGROUND

  • 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.

    PMID: 29588087BACKGROUND

  • 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.

    PMID: 33009716BACKGROUND

  • 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.

    PMID: 11049889BACKGROUND

  • 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.

    PMID: 26574762BACKGROUND

  • 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.

    PMID: 19509608BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Gizem Kececi Ozgur

    Ege University Faculty of Medicine, Department of Thoracic Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 26, 2024

First Posted

July 3, 2024

Study Start

July 24, 2023

Primary Completion

August 6, 2025

Study Completion

August 6, 2025

Last Updated

August 12, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)