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[Clinical] Some suggestions for clinical trials of hemostatic products

from CIRS by

Wound bleeding is a common surgical problem that can lead to blood loss and related complications, such as hemorrhagic shock, which can lead to death. This not only causes work difficulties for doctors, but also causes significant losses to patients. Therefore, during the surgical procedure, the multi-purpose hemostatic material is used to stop bleeding.

Although the hemostatic materials have undergone a long period of development, there are still various deficiencies, such as chemical materials, which have been eliminated due to their short-term effects such as poor hemostasis and cancer risk. Protein-based hemostatic materials, although they have enhanced hemostatic effect, they are gradually withdrawn from the market due to the potential risks of spreading blood-borne diseases, zoonotic diseases, immune reactions and protein allergies due to their containing animal proteins; Fibrous hemostatic materials circumvent the side effects of protein hemostatic materials, but the hemostatic effect is poor, and it is easy to form a place after disintegration and swelling, the metabolites are acidic, inhibit tissue growth, and the problem of residual in the body has not been solved in time. Nowadays, more starch polysaccharide hemostatic materials are used, which have the characteristics of rapid hemostasis, good fluidity, hydrophilicity and strong adhesion. After the hemostasis is completed, they can be rapidly degraded and absorbed in the short term.

The clinical trial design of hemostatic products is mostly multi-center non-inferiority design with prospective, randomized, single-blind, parallel control. The clinical trial process needs to focus on the following:

I. Single-blind trial design

In a single-blind clinical trial, only the investigator knew about the grouping, and the subjects did not know whether they were the experimental group or the control group. The advantage of this method is that the researcher can better observe and understand the subjects, and can deal with the unexpected problems that may occur on the research subjects when necessary, so as to ensure the safety of the research subjects; the disadvantage is that the researcher cannot be avoided. Subjective bias is likely to cause uneven treatment in the test group and the control group.

II. Random timing in the test

This relates to whether the entire clinical trial meets the protocol and whether the subject is effectively protected.

III. Determination of hemostasis time

The determination of the effective time is generally calculated using a stopwatch, but this will cause some problems. For example, how do researchers accurately record bleeding time? How to confirm whether this time is the exact time? Does the time on the record have subjective factors? Therefore, in the manner of recording plus video, the recording is performed in detail, and the random number information of the subject that needs to appear in the video is required.

IV. Combined medication

Since such products are wound hemostasis products, so strict rules should be applied to the use of hemostatic drugs in preoperative, intraoperative and postoperative patients to avoid interaction and affect the evaluation indicators.

V. Issuance of compensation fees for subjects

Please note whether the subject's compensation fee is paid on time during the test, and whether the examination fee of the failed patient is issued or not.

The above ideas are based on the actual problems encountered by CIRS Group in clinical trials. But clinical trials are ever-changing, so specific products need to be analyzed in detail.


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