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Recombinant human activated factor VII for upper gastrointestinal bleeding in patients with liver diseases

People with liver disease have an increased risk of upper gastrointestinal bleeding. Upper gastrointestinal bleeding is a frequent cause of morbidity and mortality in this population group. Due to severe liver damage, these people acquire coagulopathy (a bleeding disorder). Therefore, one of the approaches used for treating upper gastrointestinal bleeding is recombinant human activated factor VII, which is identical in structure and activity to human factor VII. The review includes two randomised clinical trials with 493 participants. The risk of bias was low. Both trials compared recombinant human activated factor VII with placebo. The meta‐analysis showed that the recombinant human activated factor VII does not seem to reduce mortality in patients with liver disease and suffering from upper gastrointestinal bleeding, irrespective of the grade of liver damage. The current evidence is insufficient to support or reject recombinant human activated factor VII for these patients.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2012

Recombinant factor VIIa for the prevention and treatment of bleeding in patients without haemophilia

The purpose of this review was to evaluate the evidence of effectiveness and safety for the use of recombinant factor VIIa (rFVIIa). This drug has been used in patients who are either at risk of major bleeding (e.g. because of planned high‐risk surgery), or who have uncontrolled bleeding (e.g. related to trauma). There have been many articles in the literature describing the off‐license use of this drug, which often suggest benefit. However, most of the publications are based on small numbers of patients (in case reports or case series) and may be affected by bias. Randomised controlled trials provide higher‐quality research findings and allow us to assess the evidence of drug effectiveness with more certainty.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2012

Haemostatic drug therapies for acute spontaneous intracerebral haemorrhage

More than one tenth of all strokes are caused by bleeding in the brain (known as intracerebral haemorrhage). Most of these intracerebral haemorrhages do not have an identifiable cause. The bigger the haemorrhage, the more likely it is to be fatal. Roughly one third of these haemorrhages enlarge significantly within the first 24 hours. Therefore, drugs that promote clotting ‐ known as haemostatic drugs ‐ might reduce the risk of death or being disabled after an intracerebral haemorrhage by limiting its growth, if given soon after the bleeding starts. But haemostatic drugs can cause unwanted clotting, such as heart attacks and clots in leg veins. I reviewed the evidence in 1398 adults from five phase II randomised controlled trials and one phase III randomised controlled trial. Recombinant activated factor VII (rFVIIa) was the most widely tested drug. rFVIIa did not significantly reduce the risk of a bad outcome (death or dependence) within 90 days of intracerebral haemorrhage, when compared against placebo. I found no evidence of benefit from haemostatic drug treatments for people with spontaneous intracerebral haemorrhage, though further trials appear justified.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2009

Preventing bleeding in people with congenital bleeding disorders during and after surgery

In haemophilia and other congenital bleeding disorders blood does not clot properly, which can cause excessive bleeding. This is particularly relevant during surgery, when the risk of bleeding depends on the type and severity of the clotting disorder and on the type of surgery. Therefore, during and after surgery, these individuals should receive treatment to improve the ability of their blood to clot and so prevent bleeding. Clotting factor concentrates (when available and appropriate in those individuals missing specific clotting proteins) or other non‐specific drugs for clotting, or a combination of both, are administered. It is not known what is the optimal dose or duration or method of administration of these treatments in these circumstances.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2015

Treatment for excessive bleeding after childbirth

After a woman gives birth, womb muscles contract, clamping down on the blood vessels and helping to limit bleeding when the placenta has detached. If the muscles do not contract strongly enough, very heavy bleeding (postpartum haemorrhage) can occur, which can be life threatening. These situations are common in resource‐poor countries, and maternal mortality is about 100 times higher than in resource‐rich countries. It is a very serious problem that requires effective treatments that might avoid the use of surgery to remove the womb (hysterectomy). This is often the last treatment option and leaves the woman unable to have more children. In most settings, women are given a drug at the time of birth (before excessive bleeding occurs) to reduce the likelihood of excessive blood loss. However, despite this intervention, some women bleed excessively, and this review looked to see what interventions might be used to reduce the amount of blood lost by these women. Treatment options include drugs to increase muscles contractions (such as oxytocin, ergometrine and prostaglandins like misoprostol), drugs to help with blood clotting (haemostatic drugs such as tranexamic acid and recombinant activated factor VII), surgical techniques (such as tying off or blocking of the uterine artery) and radiological interventions (to assist in blocking the main artery to the womb by using gel foams).

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2014

Desmopressin acetate (DDAVP) for preventing and treating acute bleeds during pregnancy in women with congenital bleeding disorders

Congenital bleeding disorders cause problems with bleeding during pregnancy, labour and delivery. Bleeding complications in women with congenital bleeding disorders are an important cause of disease and death linked to childbirth. Agents to stop the flow of blood are used for women with these bleeding disorders during pregnancy. Desmopressin acetate is a drug used to effectively increase the concentration of factor VIII in the blood and to increase the clumping together of platelets to stop bleeding. It does not come from human plasma and it carries no risk of infection. It might be a precious resource in patients with von Willebrand disease, haemophilia A or congenital platelet disorders to prevent and treat bleeding episodes related to pregnancy. We did not find any randomised controlled trials assessing desmopressin acetate in this group of patients. Given the ethical considerations, future randomised controlled trials are unlikely. Evidence is needed to show the risks and benefits of desmopressin acetate when used to prevent and treat bleeding during pregnancy in women with congenital bleeding disorders. While there is evidence from observational trials that shows the drug is effective in stopping and preventing bleeding, we conclude that there is still a need to generate other high quality controlled evidence.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2013

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