To observe Haemophilia patients for control of external bleeding by using VELSEAL-T

Completed

• Conditions: Hereditary factor VIII deficiency,

• Registration Number: CTRI/2017/10/009966
• Lead Sponsor: Dr Anupam Dutta

Brief Summary

Haemophilia, an inherited X-linked recessive disorder, with an incidence of 1 per 10000 births, manifests as spontaneous or trauma induced hemorrhagic episodes in patients, progressing to chronic disability and premature mortality in untreated patients or patients with sub-optimal treatment. Haemophilia A is due to a deficiency of clotting factor VIII, Haemophilia B is due to a deficiency of factor IX and Haemophilia C is due to deficiency of factor XI. Most of current treatment for haemorrhage control in hemophilic patient is transfusion of plasma; it enhances the concentration of clotting factor in blood which boosts the coagulation process.

VELSEAL-T of Datt Mediproduct Pvt Ltd is approved by state FDA, Haryana, India as a hemostatic patch to control haemorrhage. This is an innovative Hemostatic medical device to control haemorrhage ; It consists of clotting agent (Thrombin) and anti-fibrinolytic agent (Tranexamic Acid). These constituents are held on the internal surface of VELSEAL-T. That enables the rapid coagulation when blood flows into the device, leading to sealing and stabilization of wound surfaces.

It is presumed that VELSEAL-T shows its Hemostatic action even in person with low concentration of clotting factors such as in hemophilic patients. Reason being the blood which enters the matrix of VELSEAL – T undergoes an enhancement in the coagulation process due to the presence of clotting factors.

**The rationale of this study is to observe the safety and efficacy of VELSEAL-T in Haemophilia patients. The current study will collect data of haemophilia subject, if they will use VELSEAL-T as a first aid for haemorrhage control and information will be collected for the time of haemostasis and chances of secondary bleeding**.

The information/ data collected during the study will provide a comprehensive overview of the outcomes associated with VELSEAL-T and factors influencing its use in the clinical management in term of Haemostasis achievement in haemophilia patient with external bleeding.

 **Sample size calculation**

As mentioned in the previous study (M. Elaine Eyster, Robert A. Gordon, 1981) the response within subject group was normally distributed with upper limit of 1 sigma limit (i.e. 10.85 minutes) and standard deviation 3.2 minutes. If estimate lies within one minute of the given limit, then Hypothesis (**H0**) to be tested will be

**H0: µ ≤ 12 minutes**

Which states that “Average time to cease haemorrhage in the subjects receiving VELSEAL-T haemostatic device is within 12 minutes of application of device.â€

and alternate hypothesis (**H1**) was set as

**H1: µ > 12 minutes**

In this study, the Type I error probability associated with the test of this null hypothesis is 0.05 and following parameters was taken:

Level of significance (α) = 5 %

Accepted margin (d = delta) = 10.0% of 11 = 1 approx

Standard deviation (s.d) = 3.2

Standard Normal variate (Z) = 1.645

And sample size was calculated by below formula:

Formula = N = **Sample size = Zα2 \*(s.d)2/(d2)**

Thus, we need to study 28 experimental subjects to be able to reject the null hypothesis that the population mean of the experimental group is less than 12 minutes, by considered this value, the calculated **sample size is 28 and with** **20% drop-outs, the final sample size was calculated as 34.**

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-19
• Last Update Posted: 2021-01-12

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Patients above 18 years of age with haemophilia disorders who require haemostasis control.
• Patients who can provide informed consent form in writing and medically in a position to undergo consent for data collection.
• Subjects willing and able to comply with the requirements of the study protocol, including the predefined follow-up evaluations.

Exclusion Criteria

• Subjects with medical emergency, where treatment is the priority than the informed consent process and his/her representative deny to participant in the study.
• Subjects who cannot provide the 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 known possible loss of plasma or blood from other areas than wound such as lacerations, Uterine bleeding, Gastro-intestinal bleeding etc.
• Subjects with an active infection at the injury site.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To observe the hemostatic efficacy of VELSEAL-T on haemophilia subjects with external bleeding to control haemorrhage.	12 minutes

Secondary Outcome Measures

Name	Time	Method
1. Assessment of number of VELSEAL-T-T used on a single wound until complete haemostasis.	2. Assessment of VELSEAL-T related adverse events.

Trial Locations

Locations (1)

Assam Medical College and Hospital; 🇮🇳 Dibrugarh, ASSAM, India

Assam Medical College and Hospital

🇮🇳Dibrugarh, ASSAM, India

Dr Anupam Dutta

Principal investigator

9954249208

dranupamdutta@yahoo.com