Revisions for Atorvastatin and desamethasone in adult patients with chronic subdural hematoma; Phase I-II. | Registro Público Cubano de Ensayos Clínicos

28 March 2024 - 10:58am by HUPMAD		28 March 2024 - 10:58am by HUPMAD

Changes to Public title
-	Atorvastatin and desamethasone in adult patients with chronic subdural hematoma; Phase I-II.	+	Atorvastatin and dexamethasone in adult patients with chronic subdural hematoma; Phase I-II.

Revision of 28 March 2024 - 10:58am:

Atorvastatin and dexamethasone in adult patients with chronic subdural hematoma; Phase I-II.

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

ADELE Study

Scientific title:

Evaluation of the effect and safety of atorvastatin and dexamethasone in the postoperative treatment of patients with chronic subdural hematoma.

Secondary indentifying numbers:

HUMAD/HSC/2301

Issuing authority of the secondary identifying numbers:

“Manuel Ascunce Domenech” University Hospital (HUMAD)

Source(s) of monetary or material support:

Ministry of Public Health, Cuba. Biotechnology and Pharmaceutical Industries Group BioCubaFarma, Cuba.

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Reference number:

In process

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Gretel

Last name:

Mosquera Betancourt

Medical Specialty :

Doctor in Medical Sciences; Second degree specialist in Neurosurgery.

Affiliation:

“Manuel Ascunce Domenech” University Hospital (HUMAD)

Postal address:

Carretera Central Oeste, Km 4 1/2

City:

Camaguey

Country:

Cuba

Zip Code:

70700

Telephone:

+53-32231011

Email address:

gremb.cmw@infomed.sld.cu

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not applicable

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

15/06/2024

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Chronic subdural hematoma

Intervention(s):

Group I - Atorvastatin (Experimental): Atorvastatin and, Conventional treatment. The atorvastatin will be administered 20 mg daily orally for 8 weeks, starting on the first postoperative day. The Conventional treatment will be administered in the same way of the group IV. Group II - Dexamethasone (Experimental): Dexamethasone and Conventional treatment. Dexamethasone will be administered for 4 weeks in the following scheme: The first three days (starting on the first postoperative day) one vial (4 mg) will be administered intravenously every 6 hours; from day 4 to 6, one vial (4 mg) every 8 hours intravenously; on day 7, one vial (4 mg) every 12 hours intravenously; From day 8 to 10, one tablet (4mg) will be administered orally every 12 hours; and from day 11, one tablet (4 mg) will be administered orally daily until the treatment is completed. The Conventional treatment will be administered in the same way of the group IV. Group III - Atorvastatin and Dexamethasone (Experimental): Atorvastatin, Dexamethasone and Conventional treatment. The Atorvastatin will be administered in the same way of the group I, the Dexamethasone will be administered in the same way of the group II and, the Conventional treatment will be administered in the same way of the group IV. Group IV - Conventional Treatment (Control): Conventional treatment (supine position in the Fowler position at 30 to 40º, 100% supplemental oxygen, basic hydration, antimicrobials, anticonvulsants, analgesics, gastric protection) during hospital admission (7 days).

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

1. Reduction in the volume of the subdural hematoma (It will be evaluated as “Yes” when the volume in mL of the current Computed Axial Tomography decreases with respect to the initial evaluation and “No” in any other case). Measurement time: At baseline, at the 7th day and at the month. 2. Reduction in recurrences of subdural hematoma (by Computerized Axial Tomography; Yes, No). Measurement time: At baseline, at the 7th day and, at a month.

Key secondary outcomes:

1. Visualization of the membranes (Yes, No). Measurement time: At baseline, at the 7th day and at the month. 2. Collection index (numerical value). Measurement time: At a month and at 4 months. 3. Decrease in the rate of reinterventions (Yes, No). Measurement time: At a month and 4 months. 4. Reduction in operative morbidity (Yes, No). Measurement time: upon hospital discharge. 5. Survival (alive, dead). Measurement time: At hospital discharge and, At a month and 4 months. 6. Clinical prognosis (according to the Glasgow outcome assessment scale: 1) favorable (good recovery, if the patient returns to his pre-trauma activities free of sequelae or with minimal sequelae; moderate disability, if sequelae that do not allow the patient to reintegrate to his previous activity, but allow him an independent life); 2) unfavorable (severe disability, if the patient requires the assistance of another person for care; vegetative state or death)). Measurement time: At hospital discharge and, At a month and 4 months. 7. Clinical Adverse Events (AEs). They will be measured as: -Occurrence of AE (Yes, No), -Description of the AE (name of the event), -Intensity of the AE (mild, moderate, serious), -Causal relationship (unrelated, doubtful, possible, probable, definitive), -Measures adopted (None, Administration of any pharmacological therapy, Addition of a non-pharmacological therapy, Exit from the study, Hospitalization / prolongation of hospitalization), -Result (Completely resolved, Resolved with sequelae, Conditions in improvement, Present condition and unchanged, Worsening, Death caused by this event). Measurement time: daily during hospital admission and, At a month and 4 months. 8. Laboratory (numerical values of hematological and blood chemistry tests: blood count, hematocrit, leukogram with differential, platelet count, coagulogram, bleeding time, prothrombin time, coagulation time, blood gases, ALAT, ASAT, blood glucose, creatinine, lipidrogram, inogram, among others). Measurement time: At baseline, on the 7th day (at discharge) and, At a month and 4 months

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

19 years

Maximum age:

80 years

Inclusion criteria:

1. Compliance with the diagnostic criteria (tomographic of a chronic subdural hematoma, visualized as an extra-axial collection, in the shape of a crescent that extends over the surface of one or both cerebral hemispheres, independent of the density and its characteristics. morphological, causing displacement of midline structures or collapse of the ventricular system, with criteria for surgical treatment, regardless of the technique selected). 2. Age between 19 and 80 years. 3. Voluntariness of the patient (or family member) through the granting of informed (oral) consent.

Exclusion criteria:

1. Patients who are on artificial mechanical ventilation at the time of diagnosis. 2. Patients who do not recover in the immediate postoperative period and are maintained on artificial mechanical ventilation. 3. Known hypersensitivity to atorvastatin or steroids. 4. Patients treated with any of the drugs under study in the four weeks prior to inclusion in the study. 5. Patients under treatment with anticoagulants or with a coagulation disorder. 6. Patients included in other clinical trials. 7. Severe and uncontrolled arterial hypertension (systolic > 200 mmHg or diastolic > 120 mmHg) that does not decrease after treatment. 8. Pregnancy or lactation at the time of inclusion in the study (referred by the patient or family member). 9. Obvious mental inability to give consent and act accordingly with the study.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Open

Control group:

Active

Study design:

Parallel

Phase:

1-2

Target sample size:

48

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Gretel

Last Name:

Mosquera Betancourt

Specialty:

Doctor in Medical Sciences, Second degree specialist in Neurosurgery.

Affiliation:

“Manuel Ascunce Domenech” University Hospital (HUMAD)

Postal Address:

Carretera Central Oeste, Km 4 1/2

City:

Camaguey

Country:

Cuba

Zip Code:

70700

Telephone:

+53-32231011

Email :

gremb.cmw@infomed.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Gretel

Last Name:

Mosquera Betancourt

Specialty:

Doctor in Medical Sciences, Second degree specialist in Neurosurgery.

Affiliation:

“Manuel Ascunce Domenech” University Hospital (HUMAD)

Postal Address:

Carretera Central Oeste, Km 4 1/2

City:

Camaguey

Country:

Cuba

Zip Code:

70700

Telephone:

+53-32231011

Email :

gremb.cmw@infomed.sld.cu

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

“Manuel Ascunce Domenech” University Hospital (HUMAD)

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

13/12/2023

Postal address of Ethic Committee :

Carretera Central Oeste, Km 4 1/2. Camaguey, ZC: 70700. Cuba

Telephone:

+53-32231011

Email:

gremb.cmw@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

15/10/2025

Date of available results:

15/04/2026

Date of first publication:

30/11/2026

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000436

Date of Registration in Primary Registry:

28/03/2024

Record Verification Date:

2024/03/28

Next update date:

2025/03/28

Link to the spanish version:

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Atorvastatin and dexamethasone in adult patients with chronic subdural hematoma; Phase I-II.

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