The following outline provides general guidelines that should be used by ATACH‐II clinical sites relying on telemedicine for subject enrollment. Some site-specific adjustments are expected as each ATACH‐II clinical site has a different telemedicine infrastructure in place. Before the implementation of this procedure, the ATACH‐II clinical site must have its local Internal Review Board (IRB) approve the telemedicine procedure that will be implemented.
The hub site will identify spoke sites within a transfer time ceiling no greater than 2.5 h by either ground or air. The hub site will identify emergency departments at spokes that have nicardipine stocked at their pharmacies. Nicardipine on‐site will make subject randomization possible at a spoke center that will later transfer the subject while actively receiving the study drug. At spoke centers that do not stock nicardipine, only screening and optimization of transfer can be performed. Normal study procedures will be resumed when patient arrives at the hub center. After a patient has been diagnosed with ICH by CT imaging at the spoke, clinicians need to contact the hub center via telemedicine, and discuss treatment options along with the inclusion/exclusion criteria for the trial. The CT scan will be reviewed by the investigator at the hub center in real time; the ATACH‐II investigator will determine the hematoma volume using the ABC/2 technique. If enrollment criteria are met, clinicians at the hub center should discuss the clinical trial and the informed consent form with the patient or the LAR to save time. If patient or LAR agrees to participate in the trial, documentation of informed consent can occur by at least two different ways, depending on local IRB regulations.
-
6.1.
The Informed Consent Form (ICF) will be faxed to the spoke site with the date, time, and signature of the investigator at the hub site. The subject or LAR will then sign the ICF and fax it to the hub site. Local IRBs may require a witness to validate the authenticity of the signature or may require the subject or LAR to re‐consent in person upon arrival at the ATACH‐II site.
-
6.2.
The subject or LAR will sign a local paper copy of the consent form while at the spoke site after providing verbal consent to the investigator over telemedicine and will bring the form to the primary hub site. After arrival to the hub site, the ICF will be signed by the local investigator. Local IRBs may require a witness to validate the authenticity of the signature. The witness may be required to sign the informed consent form. Local IRBs may require the subject or LAR to re‐consent in person upon arrival at the ATACH‐II site.
After consent is obtained, randomization may be executed.
Nicardipine may have been initiated before randomization according to the trial protocol, but after randomization, it should be titrated to the BP goal determined by the randomization arm (<180 mm Hg versus <140 mm Hg). Treatment goal and monitoring frequencies will be communicated to the EMS personnel. Upon the patient’s arrival at the hub site, continuous adherence to the protocol should be followed.
NOTE: According to the current manual of procedures, nicardipine can be initiated up to 30 min after randomization through telemedicine, as long as the drug initiation time remains <4.5 h from symptoms onset.
|
