CirrhosisPhase 4NCT04976543
Safety of Anticoagulant Therapy After Endoscopic Treatment
A Phase 4 study testing nadroparin calcium-warfarin sequential anticoagulation in people with Cirrhosis and Portal Vein Thrombosis, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
The investigators aimed to verify the efficacy and safety of nadroparin calcium warfarin sequential (NWS) anticoagulation therapy after endoscopic therapy in PVT patients with cirrhosis and AVB. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cirrhosis, Portal Vein Thrombosis, Esophageal and Gastric Varices
- What is being tested?
- nadroparin calcium-warfarin sequential anticoagulation
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2020to 28 Jun 2022
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of cirrhosis
- Portal hypertension with esophageal and gastric varices
- diagnosis of PVT by imaging examination
- undergo endoscopic therapy
Who cannot join
- older than 75 years
- uncontrolled active bleeding
- hepatocellular carcinoma or other extrahepatic malignancy
- on-going or received antithrombotic/thrombolytic treatment
- previous treatment with TIPSS
- cavernous transformation of the portal vein
Show all 11Show fewer
- platelet count lower than 10*10 ^ 9/L, creatinine more than 170 μmol/L
- Budd-Chiari syndrome
- pregnancy or breast-feeding period
- severe cardiopulmonary diseases, severe systemic infection or sepsis
- inability to sign informed consent
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Gastroenterology,Qilu Hospital,Shandong University
Jinan, Shandong, 250012
About this study
Official title: Initiation of NWS Anticoagulation Therapy After Oesophageal Variceal Band Ligation Was Safe in Portal Vein Thrombosis Patients With Cirrhosis and Acute Variceal Bleeding: A Multi-central Randomized Controlled Trial
The investigators aimed to verify the efficacy and safety of nadroparin calcium warfarin sequential (NWS) anticoagulation therapy after endoscopic therapy in PVT patients with cirrhosis and AVB.
Read the detailed description
Acute variceal bleeding is one of the most serious complications of liver cirrhosis and is associated with significant morbidity and mortality. Portal vein thrombosis (PVT) aggravates portal hypertension and worsens hemorrhage, which Increases the risk of endoscopic therapy, and PVT has been shown to be associated with a longer time to variceal eradication, a higher risk of variceal relapse and rebleeding. So, PVT should be treated earlier. Data regarding the safety and initiation time of anticoagulant therapy in PVT patients with variceal bleeding after endoscopic therapy is lacking. Aim of this study is to verify the efficacy and safety of NWS anticoagulation therapy in PVT patients with cirrhosis and AVB after endoscopic therapy and further to explored the appropriate initiation time of NWS anticoagulation therapy after EVL in these patients.
- Conditions
- Cirrhosis, Portal Vein Thrombosis, Esophageal and Gastric Varices, Anticoagulant-induced Bleeding
- Being tested
- nadroparin calcium-warfarin sequential anticoagulation
- Keywords
- endoscopic therapy, endoscopic variceal band ligation, warfarin, nadroparin calcium
- Medical subject headings
- Fibrosis, Esophageal and Gastric Varices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nadroparin calcium-warfarin sequential anticoagulationDrug
Also called anticoagulation
The NWS therapy group were given a subcutaneous injection of nadroparin calcium every 12 hours for 1 month and switched to warfarin for 5 months. Warfarin was initiated at least 5 days before nadroparin calcium was stopped. International normalized ratio (INR) was detected every 3-4 days and adjusted carefully by 0.75mg dosage until achieve the target level of 2-3.
| Study group | Role | What they receive |
|---|---|---|
| NWS group | Experimental | nadroparin calcium injection subcutaneously every 12 hours for 1 month and switched to warfarin orally for 5 months Receives: Drug: nadroparin calcium-warfarin sequential anticoagulation |
| control group | No intervention | no anticoagulation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of overall recanalization
the sum of the fraction of patients who had complete or partial recanalization
Measured: 6-month
rate of bleeding
rates of upper gastrointestinal (GI) rebleeding, epistaxis, injection-site hemorrhage, and other bleeding events
Measured: 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start1 Feb 2020
- Primary completion31 Dec 2021
- Study completion28 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Liaocheng People's Hospital, Taian City Central Hospital
- Responsible party
- Sponsor
- Investigators
- Yanjing Gao, PhD.MD, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04976543
- Sponsor's protocol ID
- 20200202-Qilu
- Status last verified
- Feb 2020
- First submitted
- 15 Jul 2021
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initiation of NWS Anticoagulation Therapy After Oesophageal Variceal Band Ligation Was Safe in Portal Vein Thrombosis Patients With Cirrhosis and Acute Variceal Bleeding: A Multi-central Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04976543
- Acronym / sponsor ID
- 20200202-Qilu
- Conditions
- Cirrhosis, Portal Vein Thrombosis, Esophageal and Gastric Varices, Anticoagulant-induced Bleeding
- Keywords
- endoscopic therapy, endoscopic variceal band ligation, warfarin, nadroparin calcium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Collaborators
- Liaocheng People's Hospital, Taian City Central Hospital
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 28 Jun 2022 (actual)
- First posted
- 26 Jul 2021 (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.
The investigators aimed to verify the efficacy and safety of nadroparin calcium warfarin sequential (NWS) anticoagulation therapy after endoscopic therapy in PVT patients with cirrhosis and AVB.
Detailed description
Acute variceal bleeding is one of the most serious complications of liver cirrhosis and is associated with significant morbidity and mortality. Portal vein thrombosis (PVT) aggravates portal hypertension and worsens hemorrhage, which Increases the risk of endoscopic therapy, and PVT has been shown to be associated with a longer time to variceal eradication, a higher risk of variceal relapse and rebleeding. So, PVT should be treated earlier. Data regarding the safety and initiation time of anticoagulant therapy in PVT patients with variceal bleeding after endoscopic therapy is lacking. Aim of this study is to verify the efficacy and safety of NWS anticoagulation therapy in PVT patients with cirrhosis and AVB after endoscopic therapy and further to explored the appropriate initiation time of NWS anticoagulation therapy after EVL in these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NWS group | Experimental | Drug: nadroparin calcium-warfarin sequential anticoagulationnadroparin calcium injection subcutaneously every 12 hours for 1 month and switched to warfarin orally for 5 months |
| control group | No intervention | –no anticoagulation therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- clinical diagnosis of cirrhosis
- Portal hypertension with esophageal and gastric varices
- diagnosis of PVT by imaging examination
- undergo endoscopic therapy
Key exclusion criteria (11 listed)
- older than 75 years
- uncontrolled active bleeding
- hepatocellular carcinoma or other extrahepatic malignancy
- on-going or received antithrombotic/thrombolytic treatment
- previous treatment with TIPSS
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 |
|---|---|---|
| nadroparin calcium-warfarin sequential anticoagulationAlso: anticoagulationThe NWS therapy group were given a subcutaneous injection of nadroparin calcium every 12 hours for 1 month and switched to warfarin for 5 months. Warfarin was initiated at least 5 days before nadroparin calcium was stopped. International normalized ratio (INR) was detected every 3-4 days and adjusted carefully by 0.75mg dosage until achieve the target level of 2-3. | Drug | NWS group |
Primary outcome
rate of overall recanalization
Time frame: 6-month
the sum of the fraction of patients who had complete or partial recanalization
rate of bleeding
Time frame: 6-month
rates of upper gastrointestinal (GI) rebleeding, epistaxis, injection-site hemorrhage, and other bleeding events
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 Oct 2022.
- 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.
Yanjing Gao, PhD.MD principal investigator
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing nadroparin calcium-warfarin sequential anticoagulation in people with Cirrhosis and Portal Vein Thrombosis, run by Qilu Hospital of Shandong 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 4 inclusion and 11 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 Oct 2022. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
rate of overall recanalization (time frame: 6-month). 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 12 Oct 2022.