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).
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
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.
r time
'r time' value measured by thromboelastography
Measured: 24 months
k time
'k time' value measured by thromboelastography
Measured: 24 months
maximum amplitude (MA)
'MA' value measured by thromboelastography
Measured: 24 months
angle a
'angle a' value measured by thromboelastography
Measured: 24 months
Secondary outcomes (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.
- First posted3 Jul 2024
- Study start24 Jul 2023
- Primary completion6 Aug 2025
- Study completion6 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for MalignancyStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gizem Kececi Ozgur, Ege University
- Investigators
- Gizem Kececi Ozgur, Principal investigator, Ege University Faculty of Medicine, Department of Thoracic Surgery
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 28326488Mukai 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 29588087Wang 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 33009716Klein 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 11049889Tekkesin 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 26574762Van 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 19509608Kececi 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Prophylactic Low Molecular Weight Heparin by Thromboelastography in Patients Who Underwent Lobectomy Due to Malignancy
- ClinicalTrials.gov ID
- NCT06484231
- Acronym / sponsor ID
- 22-AKD-64
- Conditions
- Malignancy
- Keywords
- malignancy, lobectomy, prophylaxis, thromboelastography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 24 Jul 2023 (actual)
- Primary completion
- 6 Aug 2025 (actual)
- Study completion
- 6 Aug 2025 (actual)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent lobectomy due to malignancy
Key inclusion criteria (1 listed)
- Patients who underwent lobectomy with thoracotomy or videothoracoscopy (VATS) due to malignancy (primary or secondary lung cancer)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
r time
Time frame: 24 months
'r time' value measured by thromboelastography
k time
Time frame: 24 months
'k time' value measured by thromboelastography
maximum amplitude (MA)
Time frame: 24 months
'MA' value measured by thromboelastography
angle a
Time frame: 24 months
'angle a' value measured by thromboelastography
1 secondary outcome
complications
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Background: PubMed 28326488Moaad 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.
- Background: PubMed 29588087Mukai 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.
- Background: PubMed 33009716Wang 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.
- Background: PubMed 11049889Klein 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.
- Background: PubMed 26574762Tekkesin 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.
- Background: PubMed 19509608Van 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.
- Derived from this study: PubMed 42661399Kececi 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.
- Individual participant dataSharing planned: No
Related trials for Malignancy
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gizem Kececi Ozgur principal investigator
Ege University Faculty of Medicine, Department of Thoracic Surgery
1 site in 1 country: see every site and its status.
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.