Cerebral AneurysmEAPCAAMHO2NCT03306836
Exploration of Anticoagulation Program in Cerebral Aneurysm and Arteriovenous Malformations With Hybrid Operation 2
A study testing Heparin Sodium in people with Cerebral Aneurysm and Arteriovenous Malformations, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
In the stage of randomized controlled study, our purpose is to obtain the Intraoperative anticoagulation program supported by evidence-based medicine. Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Cerebral Aneurysm, Arteriovenous Malformations
- What is being tested?
- Heparin Sodium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 408 participants
- Where
- 1 siteChina
- Study dates
- Sep 2016to Aug 2021
- Phase
- Interventional
- 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 Up to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1.All patients undergoing hybird surgery.
Who cannot join
- Poor general condition , severe primary disease, surgical contraindications
- Patient or family refused surgery
- Fusiform aneurysm,Traumatic aneurysm,Infectious aneurysms
- Combined with other hemorrhagic cerebrovascular disease
- Combined with malignant brain tumor
- Perinatal, Pregnancy
- Patients unwilling to participate in the trial
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Yong Cao, M.D., 010-67096523 ext. 100050, caoyong6@hotmail.com
Yong Cao, M.D.
About this study
Official title: Multi-center，Single Blind，Prospective Randomized Controlled Trial of Exploration of Anticoagulation Program in Cerebral Aneurysm and Arteriovenous Malformations With Hybrid Operation
In the stage of randomized controlled study, our purpose is to obtain the Intraoperative anticoagulation program supported by evidence-based medicine.
Read the detailed description
This study is divided into anticoagulation program in cerebral aneurysm with hybrid operation and anticoagulation program in cerebral arteriovenous malformations with hybrid operation two parts, and each part divide into two stage, on the stage of registration study. This study is a multi-center, single-blind, prospective cohort study. Record the patient's intraoperative activated coagulation time Changes in detail, to observe the effect of activated coagulation time maintenance level on hemorrhage event rate of Intraoperative and postoperative 48 hours, purpose to find out the safety range of activated coagulation time level in cerebral aneurysm and arteriovenous malformations with hybrid operation. On the stage of randomized controlled study. This study is a multicenter, single-blind, prospective, randomized controlled study. Patients is divided into intraoperative standard dose group of Heparin Sodium and low dose group of Heparin Sodium randomly. To observe the effect of different anticoagulation regimens on activated coagulation time safety coverage rate during surgery, and finally develop a scientific and effective intraoperative anticoagulant therapy program.
- Conditions
- Cerebral Aneurysm, Arteriovenous Malformations
- Being tested
- Heparin Sodium
- Keywords
- Hybrid operation, Cerebral Aneurysm, Arteriovenous Malformations, Anticoagulation
- Medical subject headings
- Intracranial Aneurysm, Arteriovenous Malformations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heparin SodiumDrug
Infused with 5000 IU of Heparin Sodium
Heparin SodiumDrug
Infusion Heparin Sodium at a rate of 18 IU / kg.h
| Study group | Role | What they receive |
|---|---|---|
| Standard dose group of Heparin Sodium | Experimental | First infused with 5000 IU of Heparin Sodium, then continuous infusion at a rate of 18 IU / kg.h during the hybrid operation. Receives: Drug: Heparin Sodium |
| Low dose group of Heparin Sodium | Active comparator | infusion Heparin Sodium at a rate of 18 IU / kg.h during the hybrid operation. Receives: Drug: Heparin Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in activated coagulation time safety coverage rate from the beginning of surgery to 48 hours after surgery
Activated coagulation time average value falls in the safety coverage rate from the beginning of surgery to 48 hours after surgery.
Measured: From the beginning of surgery to 48 hours after surgery
Secondary outcomes (3)
Changes in hemorrhage event rate from the beginning of surgery to 48 hours after surgery
Hemorrhage event include intracranial hemorrhage caused by non-surgical reasons, as well as other organs or parts of the massive bleeding or small bleeding, Including subperitoneal hemorrhage, intraocular hemorrhage, gross hematuria, epistaxis time prolonged or repeated, gastrointestinal bleeding, hemoptysis, subconjunctival hemorrhage, hematoma greater than 5cm, bleeding difficult to control the and so on.
Measured: From the beginning of surgery to 48 hours after surgery
Changes in ischemia event rate from the beginning of surgery to 48 hours after surgery
Ischemia event include Cerebral infarction and transient ischemic attack.
Measured: From the beginning of surgery to 48 hours after surgery
Intraoperative blood loss
All the blood lost during the surgery should be collected and measured.
Measured: From the beginning of surgery to 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study startSep 2016
- Primary completionSep 2020 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral AneurysmStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 408 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tang-Du Hospital, Kunming Medical University, First Affiliated Hospital of Fujian Medical University, Nanjing PLA General Hospital, Fujian Medical University Union Hospital
- Responsible party
- Principal investigator, Dr. Yong Cao, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03306836
- Sponsor's protocol ID
- 2016YFC1301800-2
- Acronym
- EAPCAAMHO2
- Status last verified
- Oct 2017
- First submitted
- 31 May 2017
- Last updated
- 11 Oct 2017
- 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 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center，Single Blind，Prospective Randomized Controlled Trial of Exploration of Anticoagulation Program in Cerebral Aneurysm and Arteriovenous Malformations With Hybrid Operation
- ClinicalTrials.gov ID
- NCT03306836
- Acronym / sponsor ID
- EAPCAAMHO2 / 2016YFC1301800-2
- Conditions
- Cerebral Aneurysm, Arteriovenous Malformations
- Keywords
- Hybrid operation, Cerebral Aneurysm, Arteriovenous Malformations, Anticoagulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 408 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Tang-Du Hospital, Kunming Medical University, First Affiliated Hospital of Fujian Medical University, Nanjing PLA General Hospital, Fujian Medical University Union Hospital
- Study start
- Sep 2016 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 11 Oct 2017 (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.
In the stage of randomized controlled study, our purpose is to obtain the Intraoperative anticoagulation program supported by evidence-based medicine.
Detailed description
This study is divided into anticoagulation program in cerebral aneurysm with hybrid operation and anticoagulation program in cerebral arteriovenous malformations with hybrid operation two parts, and each part divide into two stage, on the stage of registration study. This study is a multi-center, single-blind, prospective cohort study. Record the patient's intraoperative activated coagulation time Changes in detail, to observe the effect of activated coagulation time maintenance level on hemorrhage event rate of Intraoperative and postoperative 48 hours, purpose to find out the safety range of activated coagulation time level in cerebral aneurysm and arteriovenous malformations with hybrid operation. On the stage of randomized controlled study. This study is a multicenter, single-blind, prospective, randomized controlled study. Patients is divided into intraoperative standard dose group of Heparin Sodium and low dose group of Heparin Sodium randomly. To observe the effect of different anticoagulation regimens on activated coagulation time safety coverage rate during surgery, and finally develop a scientific and effective intraoperative anticoagulant therapy program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard dose group of Heparin Sodium | Experimental | Drug: Heparin SodiumFirst infused with 5000 IU of Heparin Sodium, then continuous infusion at a rate of 18 IU / kg.h during the hybrid operation. |
| Low dose group of Heparin Sodium | Active comparator | Drug: Heparin Sodiuminfusion Heparin Sodium at a rate of 18 IU / kg.h during the hybrid operation. |
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 1.All patients undergoing hybird surgery.
Key exclusion criteria (7 listed)
- Poor general condition , severe primary disease, surgical contraindications
- Patient or family refused surgery
- Fusiform aneurysm,Traumatic aneurysm,Infectious aneurysms
- Combined with other hemorrhagic cerebrovascular disease
- Combined with malignant brain tumor
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 SodiumInfused with 5000 IU of Heparin Sodium | Drug | Standard dose group of Heparin Sodium |
| Heparin SodiumInfusion Heparin Sodium at a rate of 18 IU / kg.h | Drug | Low dose group of Heparin Sodium, Standard dose group of Heparin Sodium |
Primary outcome
Changes in activated coagulation time safety coverage rate from the beginning of surgery to 48 hours after surgery
Time frame: From the beginning of surgery to 48 hours after surgery
Activated coagulation time average value falls in the safety coverage rate from the beginning of surgery to 48 hours after surgery.
3 secondary outcomes
Changes in hemorrhage event rate from the beginning of surgery to 48 hours after surgery
Time frame: From the beginning of surgery to 48 hours after surgery
Changes in ischemia event rate from the beginning of surgery to 48 hours after surgery
Time frame: From the beginning of surgery to 48 hours after surgery
Intraoperative blood loss
Time frame: From the beginning of surgery to 48 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2017.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heparin Sodium in people with Cerebral Aneurysm and Arteriovenous Malformations, run by Beijing Tiantan Hospital 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 7 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 11 Oct 2017. 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 Yong Cao, Doctor (010-67096510, caoyong6@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in activated coagulation time safety coverage rate from the beginning of surgery to 48 hours after surgery (time frame: From the beginning of surgery to 48 hours 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 11 Oct 2017.