Anticoagulants and Bleeding DisordersNCT05545475
Safety of Anticoagulant Therapy After Tissue Glue for Gastric Varices
An observational study of Anticoagulants and Bleeding Disorders and Tissue Adhesion, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
This study aimed to clarify the safety of anticoagulant therapy after glue injection for cirrhotic variceal bleeding patients with portal vein thrombosis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anticoagulants and Bleeding Disorders, Tissue Adhesion, Gastric Varices Bleeding
- What is being tested?
- Low molecular weight heparin
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 18 Jan 2024
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All cirrhotic patients complicated with imaging-confirmed PVT and undergoing injection of tissue adhesive for GVs from three tertiary referral hospitals (Qilu Hospital of Shandong University, Shandong Provincial Hospital, and Taian City Central Hospital) were screened.
Who may be able to join
- clinical diagnosis of cirrhosis
- Portal hypertension with gastric varices
- diagnosis of PVT by imaging examination
- undergo glue injection for gastric varices
Who cannot join
- hepatocellular carcinoma or other extrahepatic malignancy
- isolated portal cavernoma
- treatment with TIPS, thrombolysis, thrombectomy or liver transplantation
- previous long-term anticoagulation therapy for various reasons
- pregnant women
- previous endoscopic treatment of GVs
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Gastroenterology,Qilu Hospital,Shandong University
Jinan, Shandong, 250012
Yanjing Gao, PhD.MD, 86-18560086087, gaoyanjing@sdu.edu.cn
About this study
This study aimed to clarify the safety of anticoagulant therapy after glue injection for cirrhotic variceal bleeding patients with portal vein thrombosis.
Read the detailed description
Acute esophagogastric varices bleeding is a common gastroenterological emergency. And the bleeding from ruptured gastric varices is massive and difficulty to stop, even after aggressive pharmacological and conservative treatment. Even after aggressive pharmacological and conservative treatment, maintaining patients without bleeding for a long time is still a challenging clinical problem. Endoscopic tissue adhesive injection is recommended by many international guidelines for acute hemostasis and secondary prevention of gastric variceal bleeding. However, postoperative glue extrusion is inevitable, and the the rebleeding caused by glue ulcers is a problem that is often faced in clinical work. In patients with portal vein thrombosis, the need for anticoagulation and the choice of anticoagulant drugs need to be carefully evaluated in terms of risk and benefit, as the dual conflicts of thrombosis and anticoagulation are involved. At present, there is no in-depth study or consensus on the effect of anticoagulation on rebleeding after glue injection in patients with portal vein thrombosis. This study is of great significance for the treatment and prognosis of patients with gastric varices combined with portal vein thrombosis.
- Being tested
- Low molecular weight heparin
- Keywords
- anticoagulants, tissue glue, gastric varices
- Medical subject headings
- Hemostatic Disorders, Tissue Adhesions, Esophageal and Gastric Varices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low molecular weight heparinDrug
Also called Nadroparin calcium, Rivaroxiban, Warfarin, Enoxaparin
Anticoagulants were given. When using warfarin, 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 |
|---|---|---|
| Anticoagulation group | 1 mg/kg of nadroparin calcium or enoxaparin every 12 h, 5000 IU of low molecular weight heparin (LMWH) every 12 h, 20 mg of rivaroxaban once daily, or warfarin adjusted by an increase or decrease of 0.75 mg until the target international normalized ratio (INR) of 2-3 was reached. Receives: Drug: Low molecular weight heparin | |
| Control group | No anticoagulation group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of a bleeding episode from glue cast extrusion
hematemesis, melena, or a ≥ 2 g drop in hemoglobin, with endoscopy-confirmed active spurting or oozing from the site of extrusion of glue casts, or an ulcer with an adherent clot or a visible vessel and no other sources of bleeding
Measured: 6-month
Secondary outcomes (1)
death
death from all causes of illness related to liver dysfunction
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 posted19 Sep 2022
- Study start1 Jan 2022
- Primary completion18 Jan 2023 (estimated)
- Study completion18 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anticoagulants and Bleeding DisordersStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong Provincial Hospital, Taian City Central Hospital
- Responsible party
- Sponsor
- Investigators
- Yanjing Gao, PhD., Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05545475
- Sponsor's protocol ID
- 20220117-Qilu
- Status last verified
- Jan 2022
- First submitted
- 23 Feb 2022
- Last updated
- 19 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Anticoagulant Therapy After Tissue Glue for Gastric Varices
- ClinicalTrials.gov ID
- NCT05545475
- Acronym / sponsor ID
- 20220117-Qilu
- Keywords
- anticoagulants, tissue glue, gastric varices
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Collaborators
- Shandong Provincial Hospital, Taian City Central Hospital
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 18 Jan 2023 (estimated)
- Study completion
- 18 Jan 2024 (estimated)
- First posted
- 19 Sep 2022 (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 aimed to clarify the safety of anticoagulant therapy after glue injection for cirrhotic variceal bleeding patients with portal vein thrombosis.
Detailed description
Acute esophagogastric varices bleeding is a common gastroenterological emergency. And the bleeding from ruptured gastric varices is massive and difficulty to stop, even after aggressive pharmacological and conservative treatment. Even after aggressive pharmacological and conservative treatment, maintaining patients without bleeding for a long time is still a challenging clinical problem. Endoscopic tissue adhesive injection is recommended by many international guidelines for acute hemostasis and secondary prevention of gastric variceal bleeding. However, postoperative glue extrusion is inevitable, and the the rebleeding caused by glue ulcers is a problem that is often faced in clinical work. In patients with portal vein thrombosis, the need for anticoagulation and the choice of anticoagulant drugs need to be carefully evaluated in terms of risk and benefit, as the dual conflicts of thrombosis and anticoagulation are involved. At present, there is no in-depth study or consensus on the effect of anticoagulation on rebleeding after glue injection in patients with portal vein thrombosis. This study is of great significance for the treatment and prognosis of patients with gastric varices combined with portal vein thrombosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anticoagulation group | – | Drug: Low molecular weight heparin1 mg/kg of nadroparin calcium or enoxaparin every 12 h, 5000 IU of low molecular weight heparin (LMWH) every 12 h, 20 mg of rivaroxaban once daily, or warfarin adjusted by an increase or decrease of 0.75 mg until the target international normalized ratio (INR) of 2-3 was reached. |
| Control group | – | –No anticoagulation group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All cirrhotic patients complicated with imaging-confirmed PVT and undergoing injection of tissue adhesive for GVs from three tertiary referral hospitals (Qilu Hospital of Shandong University, Shandong Provincial Hospital, and Taian City Central Hospital) were screened.
Key inclusion criteria (4 listed)
- clinical diagnosis of cirrhosis
- Portal hypertension with gastric varices
- diagnosis of PVT by imaging examination
- undergo glue injection for gastric varices
Key exclusion criteria (6 listed)
- hepatocellular carcinoma or other extrahepatic malignancy
- isolated portal cavernoma
- treatment with TIPS, thrombolysis, thrombectomy or liver transplantation
- previous long-term anticoagulation therapy for various reasons
- pregnant women
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 |
|---|---|---|
| Low molecular weight heparinAlso: Nadroparin calcium, Rivaroxiban, Warfarin, EnoxaparinAnticoagulants were given. When using warfarin, 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 | Anticoagulation group |
Primary outcome
the incidence of a bleeding episode from glue cast extrusion
Time frame: 6-month
hematemesis, melena, or a ≥ 2 g drop in hemoglobin, with endoscopy-confirmed active spurting or oozing from the site of extrusion of glue casts, or an ulcer with an adherent clot or a visible vessel and no other sources of bleeding
1 secondary outcome
death
Time frame: 6-month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
Related trials for Anticoagulants and Bleeding Disorders
RecruitingPhase 3
Thrombolysis in Factor Xa-inhibitors Trial
Stroke, Stroke (in Patients With Atrial Fibrillation)
Not yet recruitingPhase 4
Perioperative Dutasteride for Hemorrhage Control in Bipolar TURP Under Anticoagulation.
Benign Prostatic Hyperplasia, Postoperative Hemorrhage
RecruitingPhase 3
Phase 3 Trial of Reltodecacog Alfa (VMX-C001) vs Usual Pharmacological Care in Patients Taking a FXa Direct Oral Anticoagulant Who Require Urgent Surgery With or Without Heparin.
Blood Loss, Surgical, Coagulation Disorder
Enrolling by invitationPhase 4
LMWH vs Aspirin for VTE Prophylaxis in Orthopaedic Oncology
Sarcoma, Soft Tissue Sarcoma
RecruitingObservational study
Treatment Outcomes of Direct Oral Anticoagulants in Cerebral Venous Thrombosis in Vietnam
Cerebral Venous Thrombosis
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. 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?
An observational study of Anticoagulants and Bleeding Disorders and Tissue Adhesion, 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 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 19 Sep 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.
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 Yanjing Gao, PhD. (18560086087, gaoyanjing@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of a bleeding episode from glue cast extrusion (time frame: 6-month). 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 19 Sep 2022.