Liver CirrhosisPhase 1/2ATASICPNCT04397289
Anticoagulation Therapy After Splenectomy in Cirrhosis Patient
A Phase 1/2 study testing Heparin and Rivaroxaban in people with Liver Cirrhosis and Portal Hypertension, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
1. Inclusion and Exclusion Criteria Inclusion criteria: Inpatients who received laparotomy or laparoscopic splenectomy according to clinical, B-ultrasound scan, CT or MRI diagnosis of cirrhosis and portal hypertension. Exclusion criteria: 1. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Cirrhosis, Portal Hypertension, Anticoagulant-induced Bleeding
- What is being tested?
- Heparin and Rivaroxaban
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 12 Feb 2018to 31 Mar 2021
- Phase
- Phase 1/2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inpatients who received laparotomy or laparoscopic splenectomy according to clinical, B-ultrasound scan, CT or MRI diagnosis of cirrhosis and portal hypertension
Who cannot join
- Portal vein thrombosis found by preoperative color Doppler ultrasound or MRI examination;
- Liver cirrhosis complicated with liver tumor;
- Liver cirrhosis complicated with blood system diseases;
- Patients who have not signed the informed consent form.
Trial locations and contacts
1 site in 1 country.
China1 site
the first hospital of xi'an jiaotong University
Xi'an, Shaanxi, 710061
About this study
Official title: The Preventive Effect of Anticoagulants on the Formation of Thrombosis After Splenectomy in Liver Cirrhosis Patients With Portal Hypertension
- Inclusion and Exclusion Criteria Inclusion criteria: Inpatients who received laparotomy or laparoscopic splenectomy according to clinical, B-ultrasound scan, CT or MRI diagnosis of cirrhosis and portal hypertension.
Exclusion criteria:
- ) Portal vein system thrombosis (PVST) found by preoperative color Doppler ultrasound or MRI examination;
- ) Liver cirrhosis complicated with liver tumor;
- ) Liver cirrhosis complicated with blood system diseases;
- ) Patients who have not signed the informed consent form.
- Research subgroup According to the order of the patients, the following groups are entered in turn, and the cycle is repeated.
- ) Heparin group
- ) Rivaroxaban group
- ) Control group.
Read the detailed description
- Inclusion and Exclusion Criteria Inclusion criteria: Inpatients who received laparotomy or laparoscopic splenectomy according to clinical, B-ultrasound scan, CT or MRI diagnosis of cirrhosis and portal hypertension.
Exclusion criteria:
- ) Portal vein system thrombosis (PVST) found by preoperative color Doppler ultrasound or MRI examination;
- ) Liver cirrhosis complicated with liver tumor;
- ) Liver cirrhosis complicated with blood system diseases;
- ) Patients who have not signed the informed consent form.
- Research subgroup According to the order of the patients, the following groups are entered in turn, and the cycle is repeated.
- ) Heparin group: Low molecular weight heparin 5000U ih Q12h was given 24 hours after operation, 5 days after operation. Warfarin 1.25-2.5 mg po qd, 30 days after operation. PT（prothrombin time）/INR（international normalized ratio） was kept at 1.25-1.5.
- ) Rivaroxaban group: Rivaroxaban 10mg po qd from 24 hours after operation, 30 days after operation. PT/INR was kept at 1.25-1.5.
- ) Control group: No preventive intervention measures. If platelets in the above groups are > 500× 109/L, aspirin 100 mg qd is added for 1 month. If platelets are > 1000× 109/L, platelet collection is performed.
- Monitoring indicators Color Doppler ultrasound was reexamined 1, 2, 3 and 4 weeks after operation to find out whether PVST was present. Abdominal CT was performed when PVST was suspected. After the patient's condition is stable, the portal vein system ultrasound is reviewed monthly, and the follow-up time is 1 year.
- Being tested
- Heparin and Rivaroxaban
- Medical subject headings
- Liver Cirrhosis, Hypertension, Portal, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heparin and RivaroxabanDrug
Also called platelet collection
Low molecular weight heparin 5000U ih Q12h was given 24 hours after operation, 5 days after operation Rivaroxaban 10mg PO QD from 24 hours after operation, 30 days after operation
| Study group | Role | What they receive |
|---|---|---|
| Heparin group | Experimental | Low molecular weight heparin 5000U ih Q12h was given 24 hours after operation, 5 days after operation. Warfarin 1.25-2.5 mg po qd, 30 days after operation. PT/INR was kept at 1.25-1.5. Receives: Drug: Heparin and Rivaroxaban |
| Rivaroxaban group | Experimental | Rivaroxaban 10mg PO QD from 24 hours after operation, 30 days after operation. PT/INR was kept at 1.25-1.5. Receives: Drug: Heparin and Rivaroxaban |
| Control group | Sham comparator | No preventive intervention measures. Receives: Drug: Heparin and Rivaroxaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
thrombosis formation
The evaluation index is the incidence of PVST
Measured: 1 year after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start12 Feb 2018
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- yingmin yao, PhD, Study director, the first hospital of xi'an jiaotong university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04397289
- Sponsor's protocol ID
- XJTU1AF2017LSK-43
- Acronym
- ATASICP
- Status last verified
- Aug 2021
- First submitted
- 6 Nov 2019
- Last updated
- 26 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Preventive Effect of Anticoagulants on the Formation of Thrombosis After Splenectomy in Liver Cirrhosis Patients With Portal Hypertension
- ClinicalTrials.gov ID
- NCT04397289
- Acronym / sponsor ID
- ATASICP / XJTU1AF2017LSK-43
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 12 Feb 2018 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 21 May 2020 (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.
- Inclusion and Exclusion Criteria Inclusion criteria: Inpatients who received laparotomy or laparoscopic splenectomy according to clinical, B-ultrasound scan, CT or MRI diagnosis of cirrhosis and portal hypertension.
Exclusion criteria:
- ) Portal vein system thrombosis (PVST) found by preoperative color Doppler ultrasound or MRI examination;
- ) Liver cirrhosis complicated with liver tumor;
- ) Liver cirrhosis complicated with blood system diseases;
- ) Patients who have not signed the informed consent form.
- Research subgroup According to the order of the patients, the following groups are entered in turn, and the cycle is repeated.
- ) Heparin group
- ) Rivaroxaban group
- ) Control group.
Detailed description
- Inclusion and Exclusion Criteria Inclusion criteria: Inpatients who received laparotomy or laparoscopic splenectomy according to clinical, B-ultrasound scan, CT or MRI diagnosis of cirrhosis and portal hypertension.
Exclusion criteria:
- ) Portal vein system thrombosis (PVST) found by preoperative color Doppler ultrasound or MRI examination;
- ) Liver cirrhosis complicated with liver tumor;
- ) Liver cirrhosis complicated with blood system diseases;
- ) Patients who have not signed the informed consent form.
- Research subgroup According to the order of the patients, the following groups are entered in turn, and the cycle is repeated.
- ) Heparin group: Low molecular weight heparin 5000U ih Q12h was given 24 hours after operation, 5 days after operation. Warfarin 1.25-2.5 mg po qd, 30 days after operation. PT（prothrombin time）/INR（international normalized ratio） was kept at 1.25-1.5.
- ) Rivaroxaban group: Rivaroxaban 10mg po qd from 24 hours after operation, 30 days after operation. PT/INR was kept at 1.25-1.5.
- ) Control group: No preventive intervention measures. If platelets in the above groups are > 500× 109/L, aspirin 100 mg qd is added for 1 month. If platelets are > 1000× 109/L, platelet collection is performed.
- Monitoring indicators Color Doppler ultrasound was reexamined 1, 2, 3 and 4 weeks after operation to find out whether PVST was present. Abdominal CT was performed when PVST was suspected. After the patient's condition is stable, the portal vein system ultrasound is reviewed monthly, and the follow-up time is 1 year.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Heparin group | Experimental | Drug: Heparin and RivaroxabanLow molecular weight heparin 5000U ih Q12h was given 24 hours after operation, 5 days after operation. Warfarin 1.25-2.5 mg po qd, 30 days after operation. PT/INR was kept at 1.25-1.5. |
| Rivaroxaban group | Experimental | Drug: Heparin and RivaroxabanRivaroxaban 10mg PO QD from 24 hours after operation, 30 days after operation. PT/INR was kept at 1.25-1.5. |
| Control group | Sham comparator | Drug: Heparin and RivaroxabanNo preventive intervention measures. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inpatients who received laparotomy or laparoscopic splenectomy according to clinical, B-ultrasound scan, CT or MRI diagnosis of cirrhosis and portal hypertension
Key exclusion criteria (4 listed)
- Portal vein thrombosis found by preoperative color Doppler ultrasound or MRI examination;
- Liver cirrhosis complicated with liver tumor;
- Liver cirrhosis complicated with blood system diseases;
- Patients who have not signed the informed consent form.
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 |
|---|---|---|
| Heparin and RivaroxabanAlso: platelet collectionLow molecular weight heparin 5000U ih Q12h was given 24 hours after operation, 5 days after operation Rivaroxaban 10mg PO QD from 24 hours after operation, 30 days after operation | Drug | Control group, Heparin group, Rivaroxaban group |
Primary outcome
thrombosis formation
Time frame: 1 year after surgery.
The evaluation index is the incidence of PVST
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 26 Aug 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
yingmin yao, PhD study director
the first hospital of xi'an jiaotong university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Heparin and Rivaroxaban in people with Liver Cirrhosis and Portal Hypertension, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
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 4 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 26 Aug 2021. 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 China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
thrombosis formation (time frame: 1 year after surgery.). 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 26 Aug 2021.