Patients undergoing vitreoretinal surgery under treatment with oral anticoagulants
Conditions
Interventions
Trade Name: PRADAXA
Product Name: Dabigatran
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: DABIGATRAN
CAS Number: 872728-81-9
Other descriptive name: DABIGATRAN ETEXILATE MESILATE
Concentrat
Sponsors
NAVARRBIOMED-FUNDACION MIGUEL SERVET
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults (over 18 years) of both sexes. 2. Clinical indication for vitrectomy alone or associated with facoemulsification or scleral buckling. 3. Under treatment with any of the following oral anticoagulants: acenocumarol, dabigatran, rivaroxaban, apixaban or edoxaban. 4. Able to give informed consent for vitreoretinal surgery and to participate in the trial. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 46
Exclusion criteria
Exclusion criteria: 1. Patients unable to be operated under retrobulbar anesthesia. 2. Patients on antiplatelet therapy except if the antiaggregation is with acetylsalicylic acid. 3. Patients who have recently started oral anticoagulation (less than 1 month before screening). 4. Any medical, psychological, psychiatric, geographic or social situation that could interfere with the participation of the patient in the trial or with the follow-up and adherence with the protocol and the evaluation of the results of the present trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare hemostasis related perioperative complications of vitreoretinal surgery in patients maintaining anticoagulant therapy before surgery with respect to patients who interrupt this therapy before vitrectomy.;Timepoint(s) of evaluation of this end point: Up to 15 days after surgery;Secondary Objective: - To compare pre and postoperative visual results after vitreoretinal surgery in patients who maintain anticoagulant therapy with respect to those who interrupt this therapy before surgery. - To compare the incidence of systemic thromboembolic events after vitreoretinal surgery in those patients who maintain anticoagulant therapy with respect to those who interrupt this therapy before surgery.;Primary end point(s): - Retrobulbar hemorrhage after local anesthesia (preoperative complication). - Choroidal hemorrhage or incoercible hemorrhage in anterior chamber or vitreous cavity during surgery (intraoperative complications). - During the first two weeks after surgery, anterior chamber hemorrhage, vitreous hemorrhage, intraretinal hemorrhage or choroidal hemorrhage (postoperative complications). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Best corrected visual acuity before surgery and three months after surgery. Visual acuity will be measured in the decimal scale and converted into logMAR scale to facilitate comparison. It will be compared visual acuity pre and postoperative between all patients and also between the two groups. - Thromboembolic events during the first three months after surgery. - Other surgical procedure related complications during the first three months after surgery.;Timepoint(s) of evaluation of this end point: - Best corrected visual acuity before surgery and three months after surgery. - Thromboembolic events during the first three months after surgery. - Other surgical procedure related complications during the first three months after surgery. | — |
Countries
Spain
Contacts
Public ContactNAVARRABIOMED
NAVARRABIOMED-FUNDACION MIGUEL SERVET
Outcome results
None listed