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A randomized controlled clinical trial of conservative versus surgical treatment of type A intermural hematoma: The TIMER study

A randomized controlled clinical trial of conservative versus surgical treatment of type A intermural hematoma: The TIMER study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058558
Enrollment
Unknown
Registered
2022-04-11
Start date
2021-07-15
Completion date
Unknown
Last updated
2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type A aortic intramural hematoma

Interventions

Group 1:surgical treatment

Sponsors

Guangdong Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Within 2 weeks of onset; 2. Involvement of ascending aorta and aortic arch; 3. CTA and UCG examinations of the aorta showed crescent shape or annular high attenuation area in the aortic wall; 4. The results of aortic CTA showed that there was no internal diaphragm flapping in the aortic lumen and no false lumen forming; 5. Aortic CTA results excluded signs of penetrating ulcer.

Exclusion criteria

Exclusion criteria: 1. Aortic diameter >=50mm; 2. Hematoma thickness >=11mm; 3. Traumatic IMH; 4. Combined PAU (PAU diameter > 2cm or depth > 1cm); 5. Unmanageable grade 3 hypertension; 6. Aortic insufficiency (2+); 7. Pericardial effusion (2+) or pleural effusion (2+); 8. Unrelieved chest pain or other IMH-related symptoms; 9. Malperfusion syndrome; 10. Patients were reluctant to join the study and did not follow the follow-up protocol.

Design outcomes

Primary

MeasureTime frame
Patient survival rate;Perioperative mortality;Complication rate;Postoperative ventilator assisted time;Time in ICU;Length of stay;Patient death;The patient had major complications;Intramural hematoma progressed to dissection and required surgical treatment;

Countries

China

Contacts

Public ContactSun Tucheng

Guangdong Provincial People's Hospital

suntucheng@126.com+86 13826409699

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026