Emicizumab for surgery for patients with haemophilia
Phase 3
- Conditions
- Health Condition 1: D758- Other specified diseases of bloodand blood-forming organs
- Registration Number
- CTRI/2021/09/036767
- Lead Sponsor
- Roche Products India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Age >2 years <60 years, severe haemophilia A with or without inhibitor, elective major surgery for any indication except neurosurgical or invasive ophthalmic procedures.
Exclusion Criteria
Emergency surgery, severe organ dysfunction, coagulopathy (DIC) requiring multiple blood product support, patients requiring antiplatelet agents, patients on any other on-going trial, history of previous thromboembolic episode, previous hypersensitivity to any of the study drugs.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Haemostatic efficacy during surgery and the post-operative period upto 14 days or wound healing whichever is earlier, assessed by surgeons as excellent, good, average or poor compared to a similar surgery done in a patient with normal haemostatic system.Timepoint: 14 days and wound healing
- Secondary Outcome Measures
Name Time Method Category â?? 1: Incidence of Break through Bleeds (BTBs) in post-op period upto 14 days and the number of patients requiring additional haemostatic doses / agents (FVIII / rFVIIa / aPCC) <br/ ><br>Category â?? 2: Requirement of additional doses / haemostatic agents (FVIII / rFVIIa / aPCC) (if in the case of rFVIIa this will be more than the upper range of the planned dose for that day) <br/ ><br>Category â?? 3: Requirement of red blood cell / plasma transfusions (within 48 hours after surgery, and 7 and 14 days after surgery) <br/ ><br>Category â?? 4: Incidence of adverse events (up to 30 days after surgery). This will be recorded and correlated with haemostatic support during that phase <br/ ><br>Category â?? 5: Percentage of patients with surgical complications requiring hospitalization after discharge or second surgical procedure (within 28 days after initial surgery for the same site)Timepoint: 14days and 30days