Exploration of Anticoagulation Program in Cerebral Aneurysm and Arteriovenous Malformations With Hybrid Operation 2 (EAPCAAMHO2)
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ClinicalTrials.gov Identifier: NCT03306836 |
Recruitment Status : Unknown
Verified October 2017 by Dr. Yong Cao, Beijing Tiantan Hospital.
Recruitment status was: Recruiting
First Posted : October 11, 2017
Last Update Posted : October 11, 2017
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Condition or disease | Intervention/treatment | Phase |
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Cerebral Aneurysm Arteriovenous Malformations | Drug: Heparin Sodium | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 408 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Multi-center,Single Blind,Prospective Randomized Controlled Trial of Exploration of Anticoagulation Program in Cerebral Aneurysm and Arteriovenous Malformations With Hybrid Operation |
Actual Study Start Date : | September 2016 |
Estimated Primary Completion Date : | September 2020 |
Estimated Study Completion Date : | August 2021 |

Arm | Intervention/treatment |
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Experimental: Standard dose group of Heparin Sodium
First infused with 5000 IU of Heparin Sodium, then continuous infusion at a rate of 18 IU / kg.h during the hybrid operation.
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Drug: Heparin Sodium
Infused with 5000 IU of Heparin Sodium Drug: Heparin Sodium Infusion Heparin Sodium at a rate of 18 IU / kg.h |
Active Comparator: Low dose group of Heparin Sodium
infusion Heparin Sodium at a rate of 18 IU / kg.h during the hybrid operation.
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Drug: Heparin Sodium
Infusion Heparin Sodium at a rate of 18 IU / kg.h |
- 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.
- 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 ]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.
- 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 ]Ischemia event include Cerebral infarction and transient ischemic attack.
- Intraoperative blood loss [ Time Frame: From the beginning of surgery to 48 hours after surgery ]All the blood lost during the surgery should be collected and measured.

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Ages Eligible for Study: | up to 70 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
1.All patients undergoing hybird surgery.
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03306836
Contact: Yong Cao, Doctor | 010-67096510 | caoyong6@hotmail.com |
China, Beijing | |
Beijing Tiantan Hospital, Capital Medical University | Recruiting |
Beijing, Beijing, China, 100050 | |
Contact: Yong Cao, M.D. 010-67096523 ext 100050 caoyong6@hotmail.com | |
Principal Investigator: Yong Cao, M.D. |
Responsible Party: | Dr. Yong Cao, principal, Beijing Tiantan Hospital |
ClinicalTrials.gov Identifier: | NCT03306836 |
Other Study ID Numbers: |
2016YFC1301800-2 |
First Posted: | October 11, 2017 Key Record Dates |
Last Update Posted: | October 11, 2017 |
Last Verified: | October 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hybrid operation Cerebral Aneurysm Arteriovenous Malformations Anticoagulation |
Hemangioma Intracranial Aneurysm Aneurysm Arteriovenous Malformations Congenital Abnormalities Vascular Diseases Cardiovascular Diseases Vascular Malformations Cardiovascular Abnormalities Neoplasms, Vascular Tissue Neoplasms by Histologic Type Neoplasms |
Intracranial Arterial Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Heparin Calcium heparin Anticoagulants Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |