A Post Marketing study of VELSEAL-T to control the bleeding from severely bleeding wounds due to accidents, trauma cases and after angiography / angioplasty

Phase 4

Completed

• Conditions: Health Condition 1: T889- Complication of surgical and medical care, unspecifiedHealth Condition 2: null- Patients with severely bleeding wounds such as accidents, trauma cases, deep arterial wounds and after angiography / angioplasty

• Registration Number: CTRI/2018/02/012239
• Lead Sponsor: Datt Mediproducts Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2016-10-06
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

1.Males and females above 18 years of age who require haemostasis control for traumatic injuries, both venous and arterial bleeds and after angiography/angioplasty.

2.Subjects who can provide informed consent form in writing and medically in a position to undergo consent and screening processes.

3. The subject is willing and able to comply with the requirements of the study protocol, including the predefined follow-up evaluations.

Exclusion Criteria

1. Subjects who present with medical emergency, where treatment is more priority than the informed consent process.

2. Subjects who cannot provide informed consent such as unconscious subjects.

3. The subjects who have been treated with other higher treatment for Haemorrhage control such as Tourniquets for more than 2 hours, Blood or platelet-rich-plasma transfusion etc.

4. Subjects with haematocrit less than 38% or haemoglobin less than 10 gm%.

5. Subjects with known haemorrhagic disorders like GI bleeding, Ante partum haemorrhage, metropathia haemorrhagica, history of haematemesis, haematuria, epistaxis etc.

6. Known cases of genetic bleeding disorder.

7. Subjects who have platelet count one thousand or more below the lower normal limit.

8. Subjects with known possible loss of plasma or blood from other areas than wound such as lacerations, uterine bleeding, gastro-intestinal bleeding etc.

9. The subject has an active infection at the surgical site.

Study & Design

• Study Type: PMS
• Study Design: Not specified