To evaluate the efficacy and safety of Injection Reptilase in the prophylaxis of bleeding in patients undergoing major abdominal/ pelvic surgeries
- Conditions
- Health Condition 1: null- Prophylaxis of blood loss in intra abdominal/ pelvic surgery
- Registration Number
- CTRI/2008/091/000283
- Lead Sponsor
- Troikaa Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
(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).
(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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Actual blood loss<br>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