Haemostasis Imbalance in Chronic Liver DiseaseNCT03589430
Haemostatic Imbalance in Patients With Chronic Liver Disease
An observational study of Haemostasis Imbalance in Chronic Liver Disease, run by Assiut University.
Trial summary
To assess the level of protein C, S ,antithrombin in patients with liver cirrhosis To correlate the level of these parameters with the degree of liver cirrhosis To correlate the level of procoagulants with the level of anticoagulant proteins in liver cirrhosis Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Haemostasis Imbalance in Chronic Liver Disease
- What is being tested?
- Laboratory investigations ( protein C, protein S , antithrombin III)
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2018to 30 Mar 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with liver cirrhosis
Who may be able to join
- Patients diagnosed as liver cirrhosis confirmed clinical , biochemical and ultrasonography.
- severity of cirrhosis was assessed according to Child-Pugh score and MELD score.
Who cannot join
- history of bleeding or thrombotic disorder,
- history of renal disease, diabetes mellitus,
- ongoing or recent pregnancy,
- recent history of transfusion of blood products,
- current anticoagulation therapy.
- Hepatocellular carcinoma
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Haemostatic Imbalance in Patients With Chronic Liver Disease- Its Relation to Severity and Outcome
To assess the level of protein C, S ,antithrombin in patients with liver cirrhosis To correlate the level of these parameters with the degree of liver cirrhosis To correlate the level of procoagulants with the level of anticoagulant proteins in liver cirrhosis
Read the detailed description
The liver has a cardinal role in the haemostatic system. Liver has the major role in synthesizing all clotting factors and coagulation inhibitors. Under the physiological conditions the balanced levels of procoagulant and anticoagulants determine the risk of hemorrhage and thrombosis.
In chronic liver disease due to chronic hepatitis and underlying cirrhosis, this haemostatic imbalance leads to hypercoagulability which favors thrombosis despite the longer coagulation times of their plasma, compared with that of healthy individuals. The end stage cirrhosis is however predominately associated with bleeding tendency.
Protein C (PC) and protein S (PS) are vitamin K-dependent glycoproteins, that act as natural anticoagulants.
Antithrombin III (AT III) is a natural anticoagulant that is synthesized exclusively in parenchymal cells of the liver The cause of hypercoagulability in chronic liver disease is the reduced level of protein C and increased level of factor VIIIa .As a consequence of hypercoagulability, the deep vein thrombosis, pulmonary embolism, hepatic and portal vein thrombosis may occur.
Varnika et al 2017 found a significantly low protein C value in both chronic hepatitis and cirrhosis group when compared with control group.
Acquired deficiency of АТ III can be caused by decreased synthesis due to damage to hepatic cells Patients with CLD were (and are still) subjected to laboratory screening with the prothrombin and activated partial thromboplastin times (PT and APTT), and those with abnormal values were (are) treated with plasma or procoagulant agents to correct the abnormalities and to prevent haemorrhage during invasive procedures or to stop bleeding from the gastrointestinal tract. Saja et al., and Saray et al 2009 found significantly low protein C value in both chronic hepatitis and cirrhosis group when compared with control group. This was a sign of reduced hepatocyte synthetic capacity in chronic hepatitis. Zocco et al 2009 showed that in CLD reduction in plasma levels of PC correlate with a higher Model For End-Stage Liver Disease (MELD) score. These findings, including the present one, confirm that levels of PC are sensitive markers .
Determination of the levels of AT III and aminotransferase activity in patients with liver disease may be used for differential diagnoses and the monitoring of disease progression.
Little attention had been paid to the fact that, similar to procoagulant factors, their anticoagulant counterparts (namely protein C [PC] and antithrombin) are also reduced to the same extent in this setting.
- Being tested
- Laboratory investigations ( protein C, protein S , antithrombin III)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory investigations ( protein C, protein S , antithrombin III)Other
laboratory investigations ( protein C , protein S , antithrombin)
| Study group | Role | What they receive |
|---|---|---|
| 1 child A | child A liver cirrhosis Receives: Other: Laboratory investigations ( protein C, protein S , antithrombin III) | |
| 2 child B | child B liver cirrhosis Receives: Other: Laboratory investigations ( protein C, protein S , antithrombin III) | |
| 3 child C | child C liver cirrhosis Receives: Other: Laboratory investigations ( protein C, protein S , antithrombin III) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assesment of haemostatic profile in different stages of liver cirrhosis
assessment of the level of protein C, S ,antithrombin in patients with liver cirrhosis, and correlate the level of these parameters with the degree of liver cirrhosis
Measured: baseline
Secondary outcomes (1)
The value of anticoagulant use in patients with liver cirrhosis
Cirrhotic patients has bleeding disorders and also high possibility of developing thrmobosis , so secondary to this study which assess the cause of hypercoaguability state in liver cirrhosis, new studies can be based on this study to assess the value of use of anticoagulant therapy in cirrhotic patients who are at high risk of developing thrombosis
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start1 Sep 2018 (estimated)
- Primary completion1 Sep 2019 (estimated)
- Study completion30 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Haemostasis Imbalance in Chronic Liver DiseaseStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Mohammed Mahrous Sayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03589430
- Sponsor's protocol ID
- Haemostasis imbalance in CLD
- Status last verified
- Jul 2018
- First submitted
- 5 Jul 2018
- Last updated
- 18 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rai V, Dhameja N, Kumar S, Shukla J, Singh R, Dixit VK. Haemostatic Profile of Patients with Chronic Liver Disease- its Correlation with Severity and Outcome. J Clin Diagn Res. 2017 Aug;11(8):EC24-EC26. doi: 10.7860/JCDR/2017/24975.10451. Epub 2017 Aug 1.
PubMed 28969137Wypasek E, Undas A. Protein C and protein S deficiency - practical diagnostic issues. Adv Clin Exp Med. 2013 Jul-Aug;22(4):459-67.
PubMed 23986205Hessien M, Ayad M, Ibrahim WM, ulArab BI. Monitoring coagulation proteins during progression of liver disease. Indian J Clin Biochem. 2015 Apr;30(2):210-6. doi: 10.1007/s12291-014-0429-1. Epub 2014 Apr 19.
PubMed 25883431Tripodi A, Anstee QM, Sogaard KK, Primignani M, Valla DC. Hypercoagulability in cirrhosis: causes and consequences. J Thromb Haemost. 2011 Sep;9(9):1713-23. doi: 10.1111/j.1538-7836.2011.04429.x.
PubMed 21729237
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Haemostatic Imbalance in Patients With Chronic Liver Disease- Its Relation to Severity and Outcome
- ClinicalTrials.gov ID
- NCT03589430
- Acronym / sponsor ID
- Haemostasis imbalance in CLD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (estimated)
- Primary completion
- 1 Sep 2019 (estimated)
- Study completion
- 30 Mar 2020 (estimated)
- First posted
- 17 Jul 2018 (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.
To assess the level of protein C, S ,antithrombin in patients with liver cirrhosis To correlate the level of these parameters with the degree of liver cirrhosis To correlate the level of procoagulants with the level of anticoagulant proteins in liver cirrhosis
Detailed description
The liver has a cardinal role in the haemostatic system. Liver has the major role in synthesizing all clotting factors and coagulation inhibitors. Under the physiological conditions the balanced levels of procoagulant and anticoagulants determine the risk of hemorrhage and thrombosis.
In chronic liver disease due to chronic hepatitis and underlying cirrhosis, this haemostatic imbalance leads to hypercoagulability which favors thrombosis despite the longer coagulation times of their plasma, compared with that of healthy individuals. The end stage cirrhosis is however predominately associated with bleeding tendency.
Protein C (PC) and protein S (PS) are vitamin K-dependent glycoproteins, that act as natural anticoagulants.
Antithrombin III (AT III) is a natural anticoagulant that is synthesized exclusively in parenchymal cells of the liver The cause of hypercoagulability in chronic liver disease is the reduced level of protein C and increased level of factor VIIIa .As a consequence of hypercoagulability, the deep vein thrombosis, pulmonary embolism, hepatic and portal vein thrombosis may occur.
Varnika et al 2017 found a significantly low protein C value in both chronic hepatitis and cirrhosis group when compared with control group.
Acquired deficiency of АТ III can be caused by decreased synthesis due to damage to hepatic cells Patients with CLD were (and are still) subjected to laboratory screening with the prothrombin and activated partial thromboplastin times (PT and APTT), and those with abnormal values were (are) treated with plasma or procoagulant agents to correct the abnormalities and to prevent haemorrhage during invasive procedures or to stop bleeding from the gastrointestinal tract. Saja et al., and Saray et al 2009 found significantly low protein C value in both chronic hepatitis and cirrhosis group when compared with control group. This was a sign of reduced hepatocyte synthetic capacity in chronic hepatitis. Zocco et al 2009 showed that in CLD reduction in plasma levels of PC correlate with a higher Model For End-Stage Liver Disease (MELD) score. These findings, including the present one, confirm that levels of PC are sensitive markers .
Determination of the levels of AT III and aminotransferase activity in patients with liver disease may be used for differential diagnoses and the monitoring of disease progression.
Little attention had been paid to the fact that, similar to procoagulant factors, their anticoagulant counterparts (namely protein C [PC] and antithrombin) are also reduced to the same extent in this setting.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 child A | – | Other: Laboratory investigations ( protein C, protein S , antithrombin III)child A liver cirrhosis |
| 2 child B | – | Other: Laboratory investigations ( protein C, protein S , antithrombin III)child B liver cirrhosis |
| 3 child C | – | Other: Laboratory investigations ( protein C, protein S , antithrombin III)child C liver cirrhosis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with liver cirrhosis
Key inclusion criteria (2 listed)
- Patients diagnosed as liver cirrhosis confirmed clinical , biochemical and ultrasonography.
- severity of cirrhosis was assessed according to Child-Pugh score and MELD score.
Key exclusion criteria (6 listed)
- history of bleeding or thrombotic disorder,
- history of renal disease, diabetes mellitus,
- ongoing or recent pregnancy,
- recent history of transfusion of blood products,
- current anticoagulation therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laboratory investigations ( protein C, protein S , antithrombin III)laboratory investigations ( protein C , protein S , antithrombin) | Other | 1 child A, 2 child B, 3 child C |
Primary outcome
Assesment of haemostatic profile in different stages of liver cirrhosis
Time frame: baseline
assessment of the level of protein C, S ,antithrombin in patients with liver cirrhosis, and correlate the level of these parameters with the degree of liver cirrhosis
1 secondary outcome
The value of anticoagulant use in patients with liver cirrhosis
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
- Background: PubMed 28969137Rai V, Dhameja N, Kumar S, Shukla J, Singh R, Dixit VK. Haemostatic Profile of Patients with Chronic Liver Disease- its Correlation with Severity and Outcome. J Clin Diagn Res. 2017 Aug;11(8):EC24-EC26. doi: 10.7860/JCDR/2017/24975.10451. Epub 2017 Aug 1.
- Background: PubMed 23986205Wypasek E, Undas A. Protein C and protein S deficiency - practical diagnostic issues. Adv Clin Exp Med. 2013 Jul-Aug;22(4):459-67.
- Background: PubMed 25883431Hessien M, Ayad M, Ibrahim WM, ulArab BI. Monitoring coagulation proteins during progression of liver disease. Indian J Clin Biochem. 2015 Apr;30(2):210-6. doi: 10.1007/s12291-014-0429-1. Epub 2014 Apr 19.
- Background: PubMed 21729237Tripodi A, Anstee QM, Sogaard KK, Primignani M, Valla DC. Hypercoagulability in cirrhosis: causes and consequences. J Thromb Haemost. 2011 Sep;9(9):1713-23. doi: 10.1111/j.1538-7836.2011.04429.x.
- Related InfoLink provided by the sponsor.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Haemostasis Imbalance in Chronic Liver Disease, 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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 18 Jul 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact sara mohammed mahrous, doctor (01009605484, sarah.3000@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assesment of haemostatic profile in different stages of liver cirrhosis (time frame: baseline). 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 NCT03589430, which also lists 4 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 18 Jul 2018.