Evidence map›Paper›PMID 30046714›Full record

ArticleResearch and practice in thrombosis and haemostasis2018

Randomized, double-blind, placebo-controlled, interventional phase IV investigation to assess the efficacy and safety of r-hirudin gel (1120I.U) in patients with hematomas.

Hani El-Mowafi, Ahmed El Araby, Yasser Kandil, Ahmed Zaghloul

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Research and practice in thrombosis and haemostasis, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01960569 (Single Centre,Randomized,Phase IV Study to Assess the Topical r-Hirudin), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.7field-weighted citation impact, top 25% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01960569 phase4unknown statusnot on this map

Single Centre,Randomized,Phase IV Study to Assess the Topical r-Hirudin (Thrombexx)Efficacy in the Patients With Haematomas

TypeinterventionalSponsorMinaPharm PharmaceuticalsRan2013 to 2014Enrolled200Conditionsr-Hirudin (Thrombexx) Efficacy in Treatment of HaematomasArmsactive product ( Thrombexx) assigned to arm 1, Placebo assigned to arm 2
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Review
  2. Recent progress on formulations of hirudin.Pharmaceutical science advances · 2025
    Review
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 1 institution in 1 country.

Hani El-MowafiOrthopedic Surgery Department Mansoura University Mansoura Egypt.
Ahmed El ArabyOrthopedic Surgery Department Mansoura University Mansoura Egypt.
Yasser KandilOrthopedic Surgery Department Mansoura University Mansoura Egypt.
Ahmed ZaghloulOrthopedic Surgery Department Mansoura University Mansoura Egypt.
Mansoura University · EG

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHirudin is the most potent direct thrombin inhibitor, and recombinant forms are routinely used in anticoagulation therapy. Recombinant hirudin gels are commercially available for the treatment of hematomas and associated symptoms.

objectivesTo assess the efficacy and safety of a topically administered recombinant hirudin gel in patients with hematomas. PATIENTS/

methodsThis double-blind, placebo-controlled, phase IV investigation recruited patients presenting with at least one hematoma. Subjects were randomly assigned (1:1) recombinant hirudin gel (1120 IU/100 g) or a placebo, administered 2-3 times daily for 16 days. Changes in hematoma size, flare, and the proportion of patients achieving complete resolution of hematomas and associated edemas were investigated.

resultsBy study end, a greater proportion of subjects in the treatment group achieved a complete resolution of hematomas versus placebo (98.0% vs 71.9%;

conclusionsTopical recombinant hirudin is an effective, safe, and well tolerated intervention for the symptomatic treatment of hematomas. This trial was registered at http://www.clinicaltrials.gov as NCT01960569.

Indexed as

administrationantithrombinhematomahirudinstopicaltrauma

Identifiers

PMID30046714
PMCPMC6055561
OpenAlexW2767606866

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.