Effect of Eltrombopag Olamine on Platelet Recovery and Bleeding Complications Among Dengue Patients with Severe Thrombocytopenia_ A Randomized Controlled Trial

To determine the effect of eltrombopag olamine on platelet recovery time and bleeding complications in patients of dengue fever

It is a single-center randomized, double-blind, controlled clinical trial with a parallel group design of 50 patients.

This single-center clinical trial will be conducted at the Isolated Dengue Ward of Pak Emirates Military Hospital Rawalpindi. Patients will be randomized using online computer-generated numbers to either a control or intervention group after consent. The manual platelets count, serum albumin, serum ferritin, and lipid profile will be measured at the time of admission and 7 days after intervention, the intervention group will be given oral Tab eltrombopag 25 mg once daily for 03 days while the control group will be oral tablet of glucose for same duration.

Adult patients with dengue fever and thrombocytopenia. Patients with malaria co-infection and severe dengue will be excluded

The patients in the intervention group will be given Tab eltrombopag 25 mg once daily for 03 days. The control group will receive routine and conservative medical care along with oral tablets of Glucose for 3 days once daily.

1. The primary outcome will be platelet recovery time and incidence of bleeding complications amongst the groups. 2. The secondary outcome will be changes in inflammatory markers. Both of the outcomes will be measured on the 7th day after intervention.

We used simple randomization to ensure an unbiased and equal chance of assignment for all participants. The unit of randomization was the individual participant, ensuring that each subject’s assignment was unaffected by others. The random sequence was generated using a computer-based random number generator (RNG). Allocation concealment was strictly implemented to prevent selection bias. The randomization sequence was stored in a password-protected electronic file, and investigators enrolling participants had no prior access to assignment details.

The participants, investigator, and healthcare providers (doctors and nurses) were blinded. Blinding was achieved by placing the drug (Eltrombopag Olamine) and the placebo in identical white capsules. The medications were prepared by a pharmacist in a separate room that was inaccessible to everyone else. The white capsules, labeled with patient IDs, were provided to the healthcare providers, who administered the medications to the patients according to the labeled IDs, thereby ensuring adherence to the blinding protocol.

The Deidentified Individual Participant Data Set, Study Protocol, Statistical Analysis Plan, and Informed Consent forms will be made available to desirous researchers upon reasonable requests, and after clearance from the institutional data registry body. The said documents will be shared in a non-editable format via email after scrutinizing the need for subject documents by the requesting authorities

The data will be available 6 months after the publication of the trial.

The data will be available to researchers and teaching institutes for literary and educational purposes,

The data will be available for academic, research and literary purposes. Tt will not be available for commercial use.

The data can be obtained via Email from: Dr Fatima Masud Department of Medicine, Pak Emirates Military Hospital Rawalpindi fatimamasud454@gmail.com

Data will be made available on reasonable request, after approval from the data registry department of the institute.