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MalignancyNCT06484231

Evaluation of the Effectiveness of Prophylactic LMWH by Thromboelastography

An observational study of Malignancy, run by Ege University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignancy
How many people
25 participants
Where
1 siteTurkey (Türkiye)
Study dates
24 Jul 2023to 6 Aug 2025
How long will I take part?
3 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients who underwent lobectomy due to malignancy

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ege University Faculty of Medicine

    Izmir, Bornova, 35100

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of the Effectiveness of Prophylactic Low Molecular Weight Heparin by Thromboelastography in Patients Who Underwent Lobectomy Due to Malignancy

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.

Read the 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.

Conditions
Malignancy
Keywords
malignancy, lobectomy, prophylaxis, thromboelastography
Medical subject headings
Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. r time

    'r time' value measured by thromboelastography

    Measured: 24 months

  2. k time

    'k time' value measured by thromboelastography

    Measured: 24 months

  3. maximum amplitude (MA)

    'MA' value measured by thromboelastography

    Measured: 24 months

  4. angle a

    'angle a' value measured by thromboelastography

    Measured: 24 months

Secondary outcomes (1)
  1. complications

    development of complications

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2024
  2. Study start24 Jul 2023
  3. Primary completion6 Aug 2025
  4. Study completion6 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
25 participants (actual)
Target duration
3 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06484231
Sponsor's protocol ID
22-AKD-64
Status last verified
Aug 2025
First submitted
26 Jun 2024
Last updated
12 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28326488
  • 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.

    PubMed 29588087
  • 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.

    PubMed 33009716
  • 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.

    PubMed 11049889
  • 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.

    PubMed 26574762
  • 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.

    PubMed 19509608
  • Kececi Ozgur G, Mammadov R, Akpunar E, Akcam TI, Ozdil A, Ergonul AG, Cagirici U, Cakan A. Evaluation of changes in coagulation profile by thromboelastography in patients undergoing lobectomy for malignancy. Turk Gogus Kalp Damar Cerrahisi Derg. 2026 Aug 27. doi: 10.4274/tjtcs.2026.2026-5-16. Online ahead of print.

    PubMed 42661399

Questions about this trial

What is this clinical trial studying?

An observational study of Malignancy, run by Ege University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

r time (time frame: 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06484231, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.

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