A Post Marketing study of VELSEAL to control the bleeding from severely bleeding wounds due to accidents, trauma cases and deep arterial wounds.

Not Applicable

Completed

Conditions: Other specified complications of surgical and medical care, not elsewhere classified, Patients who require haemostasis control for traumatic injuries, both venous and arterial bleeds.,

Registration Number: CTRI/2018/03/012373

Lead Sponsor: Datt Mediproducts Pvt Ltd

Brief Summary: This is an open label, single arm PMS study with a primary objective:

To evaluate the efficacy of the VELSEAL in controlling Hemorrhage from traumatic injuries, both venous and arterial bleeds.

**Secondary objectives of study are**

Assessment of safety of VELSEAL (adverse events).

Assessment of VELSEAL success (defined as the percentage of first bleeding site applications for which hemostasis obtained within 10 minutes of study device application).

Assessment of number of VELSEAL used on a single wound until complete haemostasis.

Assessment of device-related adverse events.

To evaluate average time taken after application of VELSEAL for control of hemorrhage

**Sample size calculation and study Hypothesis :**

As per published reference, A study was conducted in Interventional Cardiology set-up to establish the safety and efficacy of the devices on basis of Events (haemorrhage, hematoma and abrasions) were found to be 7.2% in 400 subjects. This value is used for margin of error calculation; 0.05 Margin of error is for 95% CI. To calculate performance goal, both margins were merged with the initial reference value and maximum event rate of 12.25% was obtained. Taking that value in reference, the proportion based Normal Curve was obtained on Minitab. The power of 80% is maintained on comparator p from 0.12 to 0.18.

Hence, Proportion of population who continue with Haemorrhage at treated site beyond 10 minutes was planned to be less than 16%. This value was set as a performance goal (Alternate Hypothesis: less than).

Thus Null Hypothesis was set as

H0 = M1- M2 = 0,

Where M2 is actual proportion of events and M1 is performance goal = 16%

Alternate Hypothesis was set as

H1 = M1-M2 > 0.

With this, the calculated sample size at 95% CI, upper bound and 80% power was 100. Adding 20%

Drop-outs, the final sample size was calculated as 120. Hence, a sample size of 100 subjects was planned for this study.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 100

Inclusion Criteria

Males and females above 18 years of age who require haemostasis control for traumatic injuries, both venous and arterial bleeds.
Subjects who can provide informed consent form in writing and medically in a position to undergo consent and screening processes.
The subject is willing and able to comply with the requirements of the study protocol, including the predefined follow-up evaluations.

Exclusion Criteria

Subjects who present with medical emergency, where treatment is more priority than the informed consent process.
Subjects who cannot provide informed consent such as unconscious subjects.
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.
Subjects with haematocrit less than 38% or haemoglobin less than 10 gm%.
Subjects with known haemorrhagic disorders like GI bleeding, Ante partum haemorrhage, metropathia haemorrhagica, history of haematemesis, haematuria, epistaxis etc.
Known cases of genetic bleeding disorder.
Subjects who have platelet count one thousand or more below the lower normal limit.
Subjects with known possible loss of plasma or blood from other areas than wound such as lacerations, uterine bleeding, gastro-intestinal bleeding etc.
The subject has an active infection at the surgical site.

Study & Design

Study Type: PMS

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of the VELSEAL Device in controlling Hemorrhage from traumatic injuries, both venous and arterial bleeds.	within 10 minutes of study device application

Secondary Outcome Measures

Name	Time	Method
Proportion of Population demonstrating failure of Hemorrhage control within 20 minutes after application of the device.	Proportion of Population demonstrating secondary Hemorrhage after removal of VELSEAL.

Trial Locations

Locations (3): Government Medical College, Nagpur,
🇮🇳
Nagpur, MAHARASHTRA, India
King Georgeâ€™s Medical University,
🇮🇳
Lucknow, UTTAR PRADESH, India
Rajiv Gandhi Institute of Medical Science & Government General Hospital
🇮🇳
Srikakulam, ANDHRA PRADESH, India
Government Medical College, Nagpur,
🇮🇳Nagpur, MAHARASHTRA, India
Dr Raj Gajbhiye
Principal investigator
9422101440
rajgajbhiye@hotmail.com