Acute LeukemiaNCT07108686
Bleeding and Thrombotic Risk Prediction in Acute Leukemia: Clinical Utility of the Siriraj Acute Myeloid/Lymphoblastic Leukemia (SiAML) Score Versus Established Hemostatic Tools
An observational study of Acute Leukemia, run by Assiut University.
Trial summary
Acute leukemia is a blood cancer marked by rapid growth of immature cells, causing bone marrow failure and serious complications. Among these, thrombosis and bleeding are major concerns, significantly increasing illness and death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Leukemia
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Newly diagnosed patients with acute leukemia
Who may be able to join
- • Newly diagnosed patients with acute leukemia, including: Acute lymphoblastic leukemia (ALL) Acute promyelocytic leukemia (APL) Acute myeloid leukemia (AML)
Who cannot join
- • Patients with a known history of familial thrombophilia.
- Patients who received antiplatelet or anticoagulant agents prior to the diagnosis of acute leukemia.
- Patients who complained of bleeding related to any coagulation disorders
About this study
Official title: "Bleeding and Thrombotic Risk Prediction in Acute Leukemia: Clinical Utility of the Siriraj Acute Myeloid/Lymphoblastic Leukemia (SiAML) Score Versus Established Hemostatic Tools"
Acute leukemia is a blood cancer marked by rapid growth of immature cells, causing bone marrow failure and serious complications. Among these, thrombosis and bleeding are major concerns, significantly increasing illness and death. Venous thromboembolism (VTE) occurs in about 9% of patients, with some studies showing rates up to 13.6% within the first six months after diagnosis (1,2,3). Bleeding complications are also frequent, with 60-80% of acute leukemia patients developing thrombocytopenia, a major risk factor for life-threatening hemorrhagic events such as intracranial hemorrhage (ICH). In fact, up to 26% of patients may experience clinically significant bleeding during induction therapy, often within the first two weeks of treatment (4,5). The development of thrombosis and bleeding in acute leukemia is complex and involves multiple factors. Leukemic blasts promote clotting, while chemotherapy, infections, and use of central venous catheters further elevate the risk of both bleeding and thrombosis (1,6). Despite the clinical significance of these complications, predicting which patients are at highest risk remains challenging. Several predictive scores have been developed for VTE and bleeding in cancer patients, but their utility in acute leukemia is limited due to the unique risk profile of this population. Recent efforts have focused on developing and validating simplified, leukemia-specific predictive models that incorporate clinical and laboratory parameters to better stratify risk and guide management (1,7). Owattanapanich W. and his colleagues designed a new Siriraj Acute Myeloid/Lymphoblastic Leukemia (SiAML) bleeding and thrombosis scoring system for thrombohemorrhagic complications in newly diagnosed acute leukemia. They reported that this score might be valuable for prognosticating individuals at risk for bleeding and thrombotic complications. However, several limitations were identified: the small sample size, especially for APL cases, prevented analysis by leukemia subtype and may have led to underreporting of thrombohemorrhagic events. The retrospective design also resulted in missing patient data. Lastly, external validation in diverse populations is needed to confirm the accuracy of the scoring systems (7). Therefore, in our study, we aim to extend the previous work by including two additional scores: the ISTH-BAT and the Khorana score. We will compare the sensitivity and specificity of the ISTH-BAT, ISTH-DIC, Khorana, and siAML scores in relation to hemorrhagic and thrombotic complications in patients with acute leukemia. Our study also seeks to validate the clinical utility and accuracy of these scores in predicting both types of complications across all subtypes of acute leukemia, to make sure that analysis of all subtypes will be performed. Furthermore, by adopting a prospective design, we aim to minimize missing data and enhance the reliability of our findings.
- Conditions
- Acute Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| study group | patient with Acute Myeloid/Lymphoblastic Leukemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
the accuracy of the newly proposed SiAML score
To validate the clinical accuracy of the newly proposed SiAML score in predicting both bleeding and thrombotic complications in patients with Acute Leukemia .
Measured: 6 months
the accuracy of the newly proposed SiAML score
To validate the clinical utility and ensure the accuracy of the newly proposed SiAML score in predicting both bleeding and thrombotic complications in patients with Acute Leukemia .
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute LeukemiaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, maram Abdallah, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07108686
- Sponsor's protocol ID
- SiAML VS Established Hemostati
- Status last verified
- Jul 2025
- First submitted
- 31 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Bleeding and Thrombotic Risk Prediction in Acute Leukemia: Clinical Utility of the Siriraj Acute Myeloid/Lymphoblastic Leukemia (SiAML) Score Versus Established Hemostatic Tools"
- ClinicalTrials.gov ID
- NCT07108686
- Acronym / sponsor ID
- SiAML VS Established Hemostati
- Conditions
- Acute Leukemia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 7 Aug 2025 (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.
Acute leukemia is a blood cancer marked by rapid growth of immature cells, causing bone marrow failure and serious complications. Among these, thrombosis and bleeding are major concerns, significantly increasing illness and death. Venous thromboembolism (VTE) occurs in about 9% of patients, with some studies showing rates up to 13.6% within the first six months after diagnosis (1,2,3). Bleeding complications are also frequent, with 60-80% of acute leukemia patients developing thrombocytopenia, a major risk factor for life-threatening hemorrhagic events such as intracranial hemorrhage (ICH). In fact, up to 26% of patients may experience clinically significant bleeding during induction therapy, often within the first two weeks of treatment (4,5). The development of thrombosis and bleeding in acute leukemia is complex and involves multiple factors. Leukemic blasts promote clotting, while chemotherapy, infections, and use of central venous catheters further elevate the risk of both bleeding and thrombosis (1,6). Despite the clinical significance of these complications, predicting which patients are at highest risk remains challenging. Several predictive scores have been developed for VTE and bleeding in cancer patients, but their utility in acute leukemia is limited due to the unique risk profile of this population. Recent efforts have focused on developing and validating simplified, leukemia-specific predictive models that incorporate clinical and laboratory parameters to better stratify risk and guide management (1,7). Owattanapanich W. and his colleagues designed a new Siriraj Acute Myeloid/Lymphoblastic Leukemia (SiAML) bleeding and thrombosis scoring system for thrombohemorrhagic complications in newly diagnosed acute leukemia. They reported that this score might be valuable for prognosticating individuals at risk for bleeding and thrombotic complications. However, several limitations were identified: the small sample size, especially for APL cases, prevented analysis by leukemia subtype and may have led to underreporting of thrombohemorrhagic events. The retrospective design also resulted in missing patient data. Lastly, external validation in diverse populations is needed to confirm the accuracy of the scoring systems (7). Therefore, in our study, we aim to extend the previous work by including two additional scores: the ISTH-BAT and the Khorana score. We will compare the sensitivity and specificity of the ISTH-BAT, ISTH-DIC, Khorana, and siAML scores in relation to hemorrhagic and thrombotic complications in patients with acute leukemia. Our study also seeks to validate the clinical utility and accuracy of these scores in predicting both types of complications across all subtypes of acute leukemia, to make sure that analysis of all subtypes will be performed. Furthermore, by adopting a prospective design, we aim to minimize missing data and enhance the reliability of our findings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | –patient with Acute Myeloid/Lymphoblastic Leukemia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed patients with acute leukemia
Key inclusion criteria (1 listed)
- • Newly diagnosed patients with acute leukemia, including: Acute lymphoblastic leukemia (ALL) Acute promyelocytic leukemia (APL) Acute myeloid leukemia (AML)
Key exclusion criteria (3 listed)
- • Patients with a known history of familial thrombophilia.
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
the accuracy of the newly proposed SiAML score
Time frame: 6 months
To validate the clinical accuracy of the newly proposed SiAML score in predicting both bleeding and thrombotic complications in patients with Acute Leukemia .
the accuracy of the newly proposed SiAML score
Time frame: baseline
To validate the clinical utility and ensure the accuracy of the newly proposed SiAML score in predicting both bleeding and thrombotic complications in patients with Acute Leukemia .
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Leukemia, run by Assiut University.
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: opening soon, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
the accuracy of the newly proposed SiAML score (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2025.