ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 187 for:    Arteriovenous Malformation

Exploration of Anticoagulation Program in Cerebral Aneurysm and Arteriovenous Malformations With Hybrid Operation 1 (EAPCAAMHO1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03306823
Recruitment Status : Recruiting
First Posted : October 11, 2017
Last Update Posted : October 11, 2017
Sponsor:
Collaborators:
Tang-Du Hospital
Kunming Medical University
First Affiliated Hospital of Fujian Medical University
Nanjing PLA General Hospital
Fujian Medical University Union Hospital
Information provided by (Responsible Party):
Dr. Yong Cao, Beijing Tiantan Hospital

Brief Summary:
In the stage of registration study, our purpose is to find out the safety range of activated coagulation time level in cerebral aneurysm and arteriovenous malformations with hybrid operation.

Condition or disease
Cerebral Aneurysm Arteriovenous Malformations

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 Type : Observational [Patient Registry]
Estimated Enrollment : 556 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Multi-center, Single-blind, Prospective Cohort Study 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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
aneurysm
For cerebral aneurysm with hybrid operation, anticoagulation program is decided by different surgeons based on their experience and record the patient's intraoperative activated coagulation time changes in detail.
arteriovenous malformations
For arteriovenous malformations with hybrid operation, anticoagulation program is decided by different surgeons based on their experience and record the patient's intraoperative activated coagulation time changes in detail.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Intraoperative blood loss [ Time Frame: During the surgery ]
    All the blood lost during the surgery should be collected and measured.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The investigators chose the patiens from the Tiantan hospital and other hospitals that participated in this study.The patients diagnosed as cerebral aneurysm and arteriovenous malformations,and take part in hybrid operation.
Criteria

Inclusion Criteria:

1.All patients undergoing hybird surgery.

Exclusion Criteria:

  1. Poor general condition , severe primary disease, surgical contraindications
  2. Patient or family refused surgery
  3. Fusiform aneurysm,Traumatic aneurysm,Infectious aneurysms
  4. Combined with other hemorrhagic cerebrovascular disease
  5. Combined with malignant brain tumor
  6. Perinatal, Pregnancy
  7. Patients unwilling to participate in the trial

Information from the National Library of Medicine

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): NCT03306823


Contacts
Contact: Yong Cao, Doctor 010-67096510 caoyong6@hotmail.com

Locations
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   
Sponsors and Collaborators
Beijing Tiantan Hospital
Tang-Du Hospital
Kunming Medical University
First Affiliated Hospital of Fujian Medical University
Nanjing PLA General Hospital
Fujian Medical University Union Hospital

Responsible Party: Dr. Yong Cao, Principal, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier: NCT03306823     History of Changes
Other Study ID Numbers: 2016YFC1301800-Anticoagulation
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

Keywords provided by Dr. Yong Cao, Beijing Tiantan Hospital:
Cerebral Aneurysm
Arteriovenous Malformations
Hybrid operation
Anticoagulation

Additional relevant MeSH terms:
Congenital Abnormalities
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Aneurysm
Hemangioma
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases