Emicizumab for surgery for patients with haemophilia

A prospective study to investigate peri-operative management of patients with severe haemophilia A who are on Emicizumab therapy and are undergoing elective major surgeries - Not applicable

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/09/036767

Enrollment

Registered

2021-09-23

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D758- Other specified diseases of bloodand blood-forming organs

Interventions

Intervention1: Emicizumab: During surgery, all patients will be on Emicizumab 1.5 mg/kg/week. Prior to that all patients should have received 3 mg/kg/week for a minimum of 4 weeks. Maintenance dose of

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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) 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) Category â?? 3: Requirement of red blood cell / plasma transfusions (within 48 hours after surgery, and 7 and 14 days after surgery) 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 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	—

Measure

Time frame

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) 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) Category â?? 3: Requirement of red blood cell / plasma transfusions (within 48 hours after surgery, and 7 and 14 days after surgery) 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 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

—

Countries

India

Contacts

Public ContactAby Abraham

Christian Medical College

aby@cmcvellore.ac.in04162282891

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026