A Phase 4 clinical trial to evaluate safety and efficacy of Velseal to achieve Haemostasis in traumatic or surgical wound, both Venous and arterial bleeds. - VELSEA

Datt Mediproducts Pvt Ltd0 sites101 target enrollmentTBD

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Health Condition 1: T888- Other specified complications of surgical and medical care, not elsewhere classifiedHealth Condition 2: null- Patients who require haemostasis control for traumatic injuries, both venous and arterial bleeds.
Sponsor: Datt Mediproducts Pvt Ltd
Enrollment: 101
Status: Completed
Last Updated: 4 years ago

No summary available.

Registry

who.int

Start Date

TBD

End Date

September 7, 2016

Last Updated

4 years ago

Study Type

Pms

Sponsor

•1\. Males and females above 18 years of age who require haemostasis control for traumatic injuries, both venous and arterial bleeds.
•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.

•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.