To evaluate the efficacy and safety of Injection Reptilase in the prophylaxis of bleeding in patients undergoing major abdominal/ pelvic surgeries

An Open Label, Comparative, multi centre study to evaluate efficacy and safety of Injection reptilase in the prophylaxis of blood loss during intra-abdominal/ pelvic surgery

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2008/091/000283

Enrollment

100

Registered

2009-01-07

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: null- Prophylaxis of blood loss in intra abdominal/ pelvic surgery

Interventions

Intervention1: Standard Therapy for controlling blood loss + Injection Reptilase 1 NIH unit: 1 NIH unit of Injection Reptilase given IM/IV 30 minutes preoperatively, followed by 1 NIH unit IM post-ope

Eligibility

Inclusion criteria

Inclusion criteria: (1) Adult patients undergoing major elective abdominal/ pelvic surgery (2) Surgeries involving an expected blood loss of 400- 500 ml (3) Patients aged between 18 to 60 years. (4) Both sexes. (5) Patients needing hospitalization for at least 5 days. (One day pre-op & 3 post op).

Exclusion criteria

Exclusion criteria: (1) Patients aged less than 18 years and greater than 60 years. (2) Emergency surgery & surgery needing hospitalization for less than 5 days. (3) Patients with sever anemia (hematocrit <21%) (4) Patients with sudden/ massive blood loss. (5) H/O thromboembolic disorders. (6) H/O alcohol or drug abuse (7) Clinically significant impairment of hepatic and renal functions (8) Baseline laboratory values outside the clinically acceptable limits (9) Pregnant women and lactating mothers (10) Women of child bearing age not practicing contraception (11) Patients or relatives unwilling to give written informed consent (12) Participation in a clinical study involving an investigational product within past 120 days.

Design outcomes

Primary

Measure	Time frame
Intra-operative blood loss (ml )Timepoint: At the end of surgery;Intra-operative blood loss (ml )Timepoint: At the end of surgery;Intra-operative blood loss (ml )Timepoint: At the end of surgery	—

Secondary

Measure	Time frame
Actual blood loss Timepoint: At the end of study;BT/CT/PT pre and post operativeTimepoint: Within 30 minutes of surgery;Need for transfusionTimepoint: At the end of study;Pre and post op HemoglobinTimepoint: Within 30 minutes of surgery	—

Countries

India

Contacts

Public ContactDr Vijaya Jaiswal

Vijayajaiswal@troikaapharma.com

Outcome results

None listed

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