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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05517356
Other study ID # 2022YLK19
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2021
Est. completion date December 31, 2024

Study information

Verified date August 2022
Source Xiamen Cardiovascular Hospital, Xiamen University
Contact Xijie Wu, PhD
Phone +86-13799959630
Email wxjusa@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Management strategy of malperfusion syndrome in acute type A aortic dissection (ATAAD) patients remains controversial, with different views on when the surgery should be offered. At present, the mortality of ATAAD patients complicated with malperfusion is stubbornly high. The purpose of this study is to improve the outcomes of ATAAD with malperfusion syndrome. The investigators formulated tailored management strategies for malperfused patients based on the duration of symptoms onset.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Tailored management strategies
Our basic surgical strategies for the central repair operations for ATAAD are as follows. As arterial lines for cardiopulmonary bypass, side branches of the axillary and femoral arteries were used. Circulatory arrest was established when the nasopharyngeal temperature reached 25°C. Anterograde selective cerebral perfusion was performed through the right axillary artery, and the brain was perfused at approximately 5 mL/kg/min. The extent of aortic replacement was determined according to the extent of dissection involvement. For malperfused patients with symptom onset within 6 hours, the immediate central repair was performed followed by repeat CTA postoperatively, and endovascular reperfusion was applied if the malperfusion persisted. While for patients with symptom onset beyond 6 hours, delayed central repair were performed after the organ functions improved.

Locations

Country Name City State
China Department of Cardiac Surgery, Xiamen Cardiovascular Hospital of Xiamen University, School of Medicine, Xiamen University Xiamen Fujian

Sponsors (1)

Lead Sponsor Collaborator
Xiamen Cardiovascular Hospital, Xiamen University

Country where clinical trial is conducted

China, 

References & Publications (11)

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Outcome

Type Measure Description Time frame Safety issue
Primary Mortality (number of all cause death) All cause death 12 months
Secondary Low cardiac output syndrome Number of participants complicated with low cardiac output syndrome after surgery 30 days
Secondary New cerebrovascular events Number of participants complicated with new cerebrovascular events after surgery 30 days
Secondary Intestinal necrosis Number of participants complicated with intestinal necrosis after surgery 30 days
Secondary Lower limb necrosis Number of participants complicated with lower limb necrosis after surgery 30 days
Secondary Multiple organ failure Number of participants complicated with multiple organ failure after surgery 30 days
Secondary Extracorporeal membrane oxygenation Number of participants requiring extracorporeal membrane oxygenation after surgery 30 days
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