THERCA: Management of Anticoagulants and Antithrombotics in Patients With CSDH

• Sponsor: University Hospital of Ferrara (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05079295
• Collaborator: (none)
• Enrollment: 400
• Location: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 16.7

Study Details

Study Description

Brief Summary

Primary objective of the study will be to compare, up to 6 months after surgery, number of relapses (post operative re-bleeding) or intracerebral hemorrhage (others than subdural hematomas) and thromboembolic or cardiovascular ischemic events, in patients undergoing surgery for chronic subdural hematoma (CSDH). These data will be correlated to the suspension or not of antithrombotics or anticoagulants before surgery or their re-introduction after surgery.

Condition or Disease	Intervention/Treatment	Phase
Chronic Subdural Hematoma; Anticoagulant-induced Bleeding; Thromboembolic Stroke; Cardiovascular Stroke	Procedure: CSDH evacuation

Study Design

• Study Type: Observational
• Anticipated Enrollment: 400 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Thromboembolic and Hemorrhagic Risk Evaluation in Surgically Treated Patients With CSDH Taking Anticoagulants and Antithrombotics
• Actual Study Start Date: Feb 20, 2021
• Anticipated Primary Completion Date: Feb 20, 2022
• Anticipated Study Completion Date: Feb 20, 2023

Arms and Interventions

Arm	Intervention/Treatment
Group 1 Patients taking anticoagulants or antithrombotics	Procedure: CSDH evacuation; Burr hole for chronic subdural hematomas
Group 2 Controls	Procedure: CSDH evacuation; Burr hole for chronic subdural hematomas

Outcome Measures

Primary Outcome Measures

1. hemorrhagic or thromboembolic events evaluation [up to 6 months after surgery]

   hemorrhagic (re-bleedings in surgical field, other cerebral bleedings); thromboembolic events(acute ischemic stroke, acute myocardial infarction, pulmunoray embolism, deep venous thrombosis)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 95 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age > 18 years old

• Informed consent

• Evidence of CSDH which needs surgery

• patients taking antithrombotics or anticoagulants

Exclusion Criteria:

• previous surgery for CSDH

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Sant'Anna	Ferrara	Emilia-Romagna	Italy	44124

Sponsors and Collaborators

• University Hospital of Ferrara

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dott.ssa Alba Scerrati, Principal Investigator, University Hospital of Ferrara
• ClinicalTrials.gov Identifier: NCT05079295
• Other Study ID Numbers: 1102/2020/Oss/AOUFe
• First Posted: Oct 15, 2021
• Last Update Posted: Oct 27, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Dott.ssa Alba Scerrati, Principal Investigator, University Hospital of Ferrara: chronic subdural hematoma; anticoagulants; antithrombotics; thromboembolic disease; cardiovascular risk
• Additional relevant MeSH terms: Stroke; Hematoma, Subdural; Hematoma, Subdural, Chronic; Myocardial Infarction; Hematoma

Study Results

No Results Posted as of Oct 27, 2021